Incontinence, Urinary: Comprehensive Review of Medical and Surgical Aspects
INTRODUCTION ¡@

Urinary incontinence in women is not a recent medical and social phenomenon, but the relative importance attributed to urinary incontinence as a medical problem is increasing. Several factors responsible for the increased attention to incontinence can be cited, as follows:

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As a direct result, the public is becoming more aware of the problem and is becoming more active and educated about incontinence. Patient advocacy groups provide patients access to information, incontinence products, and physicians who have interest or special expertise in these disorders. In the last decade, funding opportunities for incontinence research have increased vastly. Subspeciality professional organizations and journals are now active.

Important contributions to the understanding of the structure and functioning of the lower urinary tract include an improved understanding of the anatomy and dynamic functioning of the pelvic floor and its contribution to continence. In addition, much study has been conducted to bolster the understanding of the neurophysiology of the bladder, urethra, and pelvic floor. Finally, interest in the diagnosis and treatment of incontinence is ongoing.

The discipline of urodynamic testing is a burgeoning field but remains in its scientific infancy. Techniques of dynamic imaging of the pelvic floor and lower urinary tract, along with electrophysiologic testing, hold much promise in improving the understanding of continence mechanisms and ensuring accurate diagnoses. Exciting advances in surgical, nonsurgical, and pharmacologic treatments for incontinence are reported commonly in the literature. The future ability of physicians to diagnose and treat urinary incontinence appears to be bright.

Still, much more progress is needed. In a recent survey of primary care physicians, about 40% reported that they sometimes, rarely, or never ask patients about incontinence. More than 40% of internists and family practitioners routinely recommended absorbent pads to their patients as a solution to incontinence disorders. Continued education of the public and medical professionals is needed to improve the care rendered to individuals with urinary incontinence.

History of the Procedure: Disorders of urinary incontinence have been included in medical writing since antiquity. Lesions, such as genitourinary fistula, have been uncovered in the mummified remains of corpses dating back to 2000 BC. In the 1830s and 1840s, John Peter Mettauer first reported on the successful closure of vesicovaginal fistulas, lesions resulting in severe, debilitating urinary incontinence. However, J. Marion Sims, MD, garners much of the credit for this advancement. After countless attempts and failures, he eventually refined a technique of closure using silver wire sutures that was successful in most cases.

Sims was among the first surgeons to stress the close anatomic relationship between the genital and lower urinary tracts. In the early 1900s, Howard A. Kelly at Johns Hopkins also believed that gynecology and female urology were closely interrelated. Much of his work involved diseases of the urinary tract, and many authorities consider him an important figure in the founding of urology as a surgical specialty. Kelly is credited, along with W. A. Dunn, with the first significant surgical procedure for stress incontinence, now referred to as the Kelly plication.

Since Kelly's time, literally hundreds of procedures for the treatment of female incontinence have been devised. Only a few have stood the test of time. New procedures and modifications of older procedures continue to be developed. Few of these procedures have been subject to sufficient scientific scrutiny. The long-term efficacy of most incontinence operations is unknown. Most recently, procedures stressing minimally invasive surgical access have come to the forefront.

In addition to surgical advancements, physicians in the second half of the century have witnessed many other milestones in the study and treatment of female incontinence, including the following:

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Problem: According to the International Continence Society (ICS), urinary incontinence as a medical disorder is "a condition in which involuntary loss of urine is a social or hygienic problem and is objectively demonstrable." Urinary incontinence can be thought of as a symptom as reported by the patient, as a sign that is demonstrable on examination, and as a disorder. Urinary incontinence should not be thought of as a disease because no specific etiology exists; most individual cases are likely multifactorial in nature. The etiologies of urinary incontinence are diverse and, in many cases, incompletely understood.

In 1989, the National Institutes of Health Consensus Development Conference estimated the annual cost to society of urinary incontinence to be $10.3 billion. Some experts believe that this is a conservative estimate. More recently, this figure has been increased to $15 billion per year. True costs can be difficult to estimate because many individuals do not come to the attention of medical specialists. Some individuals pay out of pocket for adult incontinence undergarments, absorbable pads, skin care products, deodorants, and increased laundry expenses.

The psychosocial costs and morbidities are even more difficult to quantify. Embarrassment and depression are common. The affected individual may experience a decrease in social interactions, excursions out of the home, and sexual activity. The psychosocial impact on at-home caregivers, spouses, or family members rarely is considered. Recently, a questionnaire was developed to assess the quality of life of incontinent women. This questionnaire was easy to use, valid, and reliable. This tool may be a valuable adjunct to pretherapy and posttherapy assessment, as well as valuable in comparing the quality of life impact of different urodynamic diagnoses.

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Frequency: Urinary incontinence is a common medical disorder. In the United States, an estimated 13 million adults experience significant involuntary urine loss. The precise prevalence of urinary incontinence is difficult to estimate. Part of the difficulty has been in defining the degree, quantity, and frequency of urine loss necessary to qualify as pathologic. Definitions have varied significantly among studies. The prevalence rate in females aged 15-64 years has been estimated at 10-25%, and, in males, the estimated rate is 1.5-5%. In one study of randomly chosen women aged 30-59 years, 26% reported incontinence at some time during their lives, and 14% perceived incontinence to be a social or hygienic problem.

Urinary incontinence occurs in 17-46% of community dwelling women older than 60 years. In the nursing home population, incontinence may be observed in as many as 38-83% of individuals. At any age, urinary incontinence is more than 2 times more common in females than in males. Urge incontinence constitutes over 50% of overall incontinence in men, 10-15% in younger women, and 30-40% in older women. Some studies demonstrate an increasing prevalence of urinary incontinence with age. Stress incontinence tends to be more common in women younger than 65 years. In patients older than 65 years, urge incontinence and mixed (ie, urge and stress) incontinence are more common.

Studies are not in agreement. One series by Yarnell and associates noted no significant increase in the prevalence of incontinence in women older than 35 years. Contributing factors with regard to age-related increases in urinary incontinence include a weakening of connective tissue, genitourinary atrophy due to hypoestrogenism, increased incidence of contributing medical disorders, increased nocturnal diuresis, and impairments in mobility and cognitive functioning.

Etiology: No single etiologic factor can be implicated in each case of urinary incontinence. Structural and functional disorders involving the bladder, urethra, ureters, and surrounding connective tissue can contribute. In addition, a disorder of the spinal cord or central nervous system (CNS) may be the major etiologic factor in some cases. Medical comorbidities also can be important. Finally, some cases of urinary incontinence may be pharmacologically induced. Even when examining an individual patient, one must be aware that the incontinence may have multiple etiologies, each with some degree of contribution to the overall disorder.

Understanding the risk factors for urinary incontinence helps shed some light on the underlying etiologic factors at work. Complete agreement does not exist in the literature regarding the risk factors for incontinence. The following are some of the more commonly cited risk factors:

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The etiology of urinary incontinence can be examined from many viewpoints. One way to classify types of incontinence by etiology is to first look at the anatomical structure(s) involved in the incontinence. A simplistic but conceptually useful method of classification emerges. Bladder-related, urethral, and ureteric etiologies of incontinence can be described.

Bladder-related incontinence consists of 2 main types, involuntary bladder contractions (ie, with or without loss of compliance) and a breach of anatomic integrity. Detrusor hyperreflexia is the urodynamic diagnosis made when involuntary bladder contractions are identified in the setting of a causative neurologic condition. Neurologic disorders such as MS, spinal cord injuries, CNS tumors, and meningomyelocele can be responsible for detrusor hyperreflexia. More commonly, involuntary bladder contractions are idiopathic in nature. The corresponding urodynamic diagnosis is detrusor instability. Also, loss of bladder wall compliance due to radiation injury, outlet obstruction, overdistension (ie, overflow incontinence), and chronic severe inflammation can result in nonphasic increases in intravesical pressure. Bladder irritation, as can result from infection, inflammation, bladder stones, foreign bodies, and neoplasms, also can result in involuntary bladder contractions.

Among the disorders of bladder integrity are vesicovaginal or vesicocutaneous fistulas and untreated extrophy of the bladder.

Urethral-related causes of incontinence include extrinsic and intrinsic types. Extrinsic urethral etiologies refer mainly to the loss of anatomic support to the proximal urethra and urethrovesical junction (UVJ), including genuine stress incontinence (GSI). In addition, some types of outlet obstruction can be placed in this class. Intrinsic urethral etiologies of incontinence can be further subdivided into anatomic and functional types. Examples of anatomic intrinsic urethral problems include fistulas, urethral diverticula, and epispadias. Examples of intrinsic functional urethral disorders are intrinsic sphincter deficiency (ISD) and urethral instability.

Ureteral etiologies of incontinence are rare and generally involve congenital anatomic abnormalities such as ectopic ureter or anatomic injuries (eg, ureterovaginal fistulas). This type of classification system, although a useful conceptual tool, is an oversimplification. For example, some types of incontinence may not fit neatly into any one category. Overflow incontinence due to sensory neuropathy can be thought of as both a neurogenic and, ultimately, a compliance problem. Outlet obstruction usually is an extrinsic urethral problem but also can be reasonably classified as a bladder-related etiology because, ultimately, the incontinence may be due to involuntary bladder contractions. Detrusor instability (DI) can be thought of as a bladder problem, but, in most patients, the involuntary detrusor contraction is accompanied by urethral relaxation. In addition, mixed types of incontinence commonly are encountered, such as coexistent GSI and DI.

Another common classification system uses the type of symptomatology as an initial descriptor and then subdivides these categories by structural or functional etiology. The following are the ICS definition of the types of incontinence:

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This classification system also is problematic. For example, urethral instability, a rare and poorly understood disorder, does not fit neatly into any single category. Incontinence due to urethral diverticulum is, likewise, difficult to classify. Some cases of DI may be triggered by cough or sneeze and, thus, may present with predominantly stress incontinence complaints. These classification systems, although not perfect, do assist the practitioner in placing the etiologies of incontinence into a conceptual framework, which aids in understanding the pathophysiology. A diagnosis based on an understanding of the pathophysiology should be the desired goal of any incontinence evaluation.

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Pathophysiology:

Stress incontinence

The pathophysiology of stress incontinence is incompletely understood and deceptively complex. During episodes of stress incontinence, the generated intra-abdominal pressure causes a coincident rise in intravesical pressure. The rise in intravesical pressure is greater than the rise in urethral pressure. Urethral resistance is overcome, resulting in leakage. Leakage ceases when bladder pressure again falls below urethral pressure.

Most cases of stress incontinence are believed to be related to damage to the neuromuscular functioning of the pelvic floor, coupled with injury, both remote and ongoing, to the connective tissue supports of the urethra and bladder neck. Loss of intrinsic urethral tone also may be involved in the pathologic picture. Neuromuscular damage to the voluntary striated urethral sphincter is believed to be the main culprit, but mucosal atrophy, hypovascularity, and local scarring also may be involved.

If the predominant mechanism of the stress incontinence is believed to be related to the loss of intrinsic urethral function, then the diagnosis is ISD. If loss of urethral support is thought to be the primary pathology, the disorder is called GSI. The degree of loss of both of these biologic parameters, urethral support and intrinsic urethral tone, probably falls in a bell-shaped distribution across stress incontinence populations; therefore, noting that most cases of stress incontinence have some degree of both types of pathology is important.

During times of increased intra-abdominal pressure, individuals with stress incontinence may display hypermobility or rotational descent of the UVJ. How this finding is linked to stress incontinence is uncertain, but many theories exist. In women without stress incontinence or urethral hypermobility, the urethra is stabilized during stress by several interrelated mechanisms.

One mechanism is reflex, or voluntary closure, of the pelvic floor. Contraction of the levator ani complex elevates the proximal urethra and bladder neck, tightens intact connective tissue supports, and elevates the perineal body, which may serve as a urethral back stop.

The second mechanism involves intact connective tissue support to the bladder neck and urethra. The pubocervicovesical or anterior endopelvic connective tissue in the area of the bladder neck is attached to the back of the pubic bone, the arcus tendineus fascia pelvis, and the perineal membrane. The pubourethral ligaments also suspend the mid urethra to the back of the pubic bone. These components form the passive supports to the urethra and bladder neck. During times of increased intra-abdominal pressure, if these supports are intact, they augment the supportive effect of muscular closure of the pelvic floor.

The third mechanism involves 2 bundles of striated muscle, the urethrovaginal sphincter and the compressor urethrae, found at the distal aspect of the striated urethral sphincter. These muscles may aid in compressing the urethra shut during stress maneuvers. These muscles do not surround the urethra like the striated sphincter but lie along the lateral and ventral aspects. The exact function and importance of these muscles are controversial. Some authors suggest that the urethrovaginal sphincter and the compressor urethrae may provide compression and increased pressure in the distal urethra during times of stress.

Damage to the nerves, muscle, and connective tissue of the pelvic floor is important in the genesis of stress incontinence. Intrapartum injury during childbirth probably is the most important mechanism. Aging, hypoestrogenism, chronic connective tissue strain due to primary loss of muscular support, activities or medical conditions resulting in long-term repetitive increases in intra-abdominal pressure, and other factors can contribute. During the intrapartum period, 3 types of lesions can occur—levator ani muscle tears, connective tissue breaks, and pudendal/pelvic nerve denervation. Any of these injuries can occur in isolation but are more likely to occur with 2 or more in combination. The long-term result may be the loss of active and passive urethral support and loss of intrinsic urethral tone.

Some believe that the loss of urethral and bladder neck support impairs urethral closure mechanisms during times of increased intra-abdominal pressure. This phenomenon can be viewed in several ways. Under normal circumstances, some hypothesize that any increase in intra-abdominal pressure is transmitted equally to the bladder and proximal urethra. This likely is due to the retropubic location of the proximal and mid urethra within the sphere of intra-abdominal pressure. At rest, the urethra has a higher intrinsic pressure than the bladder. This pressure gradient relationship is preserved if pressure transmission during acute increases in intra-abdominal pressure is equal to both organs. When the urethra is hypermobile, as it descends and rotates under the pubic bone, pressure transmission to the walls of the urethra may be diminished. Intraurethral pressure falls below bladder pressure, resulting in urine loss.

A related way of describing the mechanism of hypermobility-related stress incontinence is the hammock theory described by J.O. DeLancey, MD. Usually, in a person without incontinence, a cough or other acute increase in intra-abdominal pressure applies a downward force to the urethra. The urethra then is compressed shut against the firm support provided by the anterior vaginal wall and associated endopelvic connective tissue sheath. If the endopelvic connective tissue is detached from its normal lateral fixation points at the arcus tendineus fascia pelvis, then optimal urethral compression does not take place, possibly resulting in stress leakage.

A simple analogy is that of a garden hose (urethra) running over a pavement surface (anterior endopelvic connective tissue). A force is applied in a downward direction using the foot (increased intra-abdominal pressure). This force compresses the hose shut, occluding flow. If the same hose is run through a soft area of mud (damaged connective tissue), then the downward force does not occlude the hose but, rather, pushes the hose deeper into the mud.

Other interesting alternative theories of the mechanism of stress incontinence have been described. One description stems from research involving ultrasound visualization of the bladder neck and proximal urethra during stress maneuvers. Findings of potential importance include the following: (1) 93% of patients with stress incontinence displayed funneling of the proximal urethra with straining, and one half of these individuals also showed funneling at rest; and, (2) during stress maneuvers, the urethra did not rotate and descend as a single unit. The investigators found that the posterior urethral wall moved farther than the anterior wall.

Although mobile, the anterior urethral wall has been observed to stop moving, as if tethered, while the posterior wall continued to rotate and descend. The authors hypothesize that the pubourethral ligaments arrest rotational movement of the anterior, but not the posterior, wall. The authors believe that the resulting separation of the anterior and posterior urethral walls might open the proximal urethral lumen, thus allowing or contributing to stress incontinence.

Urge incontinence

The ICS describes the unstable bladder as one that has been shown objectively to contract spontaneously during the filling phase of cystometry, while the patient is inhibiting or attempting to inhibit voiding. If these contractions result in urinary leakage, then the term urge incontinence is used. In the patient who is nonneuropathic, this disorder is called DI. In situations where a definable causative neuropathic disorder exists, the coexisting urinary incontinence disorder is termed detrusor hyperreflexia. These disorders can be quite debilitating. Recently, a study using a quality of life assessment of women with incontinence showed that women with DI consistently had a worse quality of life than did women with other urodynamic diagnoses. In light of such data, understanding the pathophysiology of urge incontinence takes on great importance.

Detrusor instability

DI in adult patients is a disorder of unclear etiology and an incompletely understood pathophysiology. DI represents about 90% of the cases of urge incontinence/bladder instability. In most patients, a sensation of urgency occurs first, followed by the initiation of an involuntary bladder contraction, and, finally, urethral relaxation. A minority (11-42%) of patients may experience urethral relaxation first, thereby mimicking normal micturition. More rarely, urethral relaxation exists as an isolated event. The corresponding urodynamic diagnosis for this condition is urethral instability. In some instances, DI may be triggered by such specific events as coughing, hand washing, changes in posture or position, an increase in the speed of bladder filling, orgasm, and anticipation of voiding (ie, key in lock incontinence). In other cases, initiating events may be less obvious or not identifiable. Less commonly, patients may complain of episodes of unexpected bladder emptying in the complete absence of any urgency.

Some researchers believe DI to represent the premature initiation of a normal micturition reflex. In vitro studies of bladder muscle strips of patients with DI have demonstrated an increase in response to electrical stimulation and an increased sensitivity to stimulation with acetylcholine. These findings may indicate a higher sensitivity to efferent neurologic activity or a lower threshold of acetylcholine release needed to initiate a detrusor contraction. A relative cholinergic denervation may explain some of these findings. This proposed mechanism is most plausible in cases of de novo DI, which follow hysterectomy or other pelvic surgery. The mechanism of denervation in idiopathic DI is less certain. Subtle obstruction and the effects of aging on smooth muscle and the autonomic nervous system are 2 possible contributors.

Another finding described in bladder muscle specimens from patients with DI is that of local loss of inhibitory medullary neurologic activity. Vasoactive intestinal peptide, a smooth muscle relaxant, is decreased markedly in the bladders of patients with DI. In addition, bladders of individuals with DI have been found deficient in smooth muscle–relaxing prostaglandins. A recent study proposed that urge incontinence, regardless of the triggering mechanism, may share a final common pathway of myogenic dysfunction of the detrusor. Spread of contractile signals via cell-to-cell coupling was proposed as the likely mechanism.

Another possible explanation for DI in a subgroup of patients involves the triggering of the micturition reflex by leakage of urine into a funneled and partially incompetent proximal urethra. This theory is consistent with the findings of DI caused by coughing or changing position.

Mixed incontinence is a common finding in older patients with urinary incontinence disorders. Often, stress incontinence symptoms precede urge incontinence symptoms in these individuals. Urgency without actual urge-related urine loss also is a common complaint of patients with stress incontinence. Some patients with stress incontinence have urine leakage into the proximal urethra that may, at first, trigger sensory urgency and/or bladder contractions, which initially are suppressible. Later, in a subgroup of these individuals, myopathic changes may occur in the bladder that make the spread of abnormally generated contractile signals more efficient and more difficult to suppress voluntarily. The development of clinical DI may follow.

Most recently, a comparison study was undertaken of bladder muscle strips from patients with severe idiopathic DI and from organ donors with no known urologic problems. The following are some of the findings:

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The authors believe that the primary abnormality in idiopathic DI is at the detrusor muscle level with an increased capacity for spontaneous myogenic contractile activity and spread of electrical activity from cell to cell, resulting in tetanic contractions. Epidemiological studies have shown an association between DI and irritable bowel syndrome. Some authorities have proposed that a syndrome of smooth muscle dysfunction may exist in some individuals.

Another study demonstrated the presence of an increased ratio of abnormal-to-normal cell junctions in patients with bladder dysfunction. The increased ratio was demonstrated most markedly in patients with idiopathic DI. To a lesser degree, these changes also were observed in patients with outlet obstruction combined with DI and with idiopathic sensory urgency alone. The authors believe that idiopathic sensory urgency might represent a milder or less overt variant of DI. They feel that, in the future, bladder biopsy with structural evaluation of cell junctions might become a useful clinical tool in the diagnostic evaluation of bladder dysfunction.

Urethral instability

The diagnosis of urethral instability occasionally is made following the urodynamic workup of incontinence. The role of this entity within the realm of incontinence disorders is controversial. The diagnosis is made when a fall in urethral pressure is observed with a stable bladder pressure and coincident urinary leakage. Some investigators believe that urethral instability represents a variant of DI, where pressure equalization occurs rapidly between the bladder and urethra. Therefore, the rise in intravesical pressure indicative of DI is not observed. Other authors have commented that urethral instability does not respond reliably to conventional pharmacotherapy for DI. This finding suggests that the pathophysiology of urethral instability is different. Reports on treating urethral instability with drugs that increase urethral tone can be found in the literature.

Detrusor hyperreflexia

Detrusor hyperreflexia is a condition of uninhibited detrusor contractions in the presence of a neurologic lesion believed to be causative. In these cases, the pathophysiology of the incontinence can be traced back to a pathologic process involving the suprasacral spinal cord or CNS. Such disorders include spinal cord injuries, MS, cerebrovascular disease, stroke, Parkinson disease, dementia, and CNS/spinal neoplasia.

Spinal cord injuries interrupt the sacral reflex arc from the suprasacral spinal cord, cerebral cortex, and higher centers. These pathways are crucial for voluntary and involuntary inhibition. In the initial phase of spinal cord injury, the bladder is areflexic and overflow incontinence results. Later, detrusor hyperreflexia usually is found upon urodynamic evaluation.

The pathophysiology of MS is that of demyelinating plaques in the white matter of the cerebral cortex, cerebellum, brain stem, spinal cord, and optic nerve. Plaques involving the frontal lobe or lateral columns can produce lower urinary tract disorders. Incontinence may be the presenting symptom of MS in about 5% of the cases. Approximately 90% of individuals with MS experience urinary tract dysfunction during the course of the disease. A summary of the published series of urodynamic findings in MS demonstrated that in patients with lower urinary tract dysfunction, the most common urodynamic diagnosis is detrusor hyperreflexia (62%). Detrusor-sphincter dyssynergia (25%) and detrusor hyporeflexia (20%) also are common. Obstructive findings are much more common in males. Of note, the urodynamic diagnosis may change over time as the disease progresses.

Hemorrhage, infarction, or vascular compromise to certain areas of the brain can result in lower urinary tract dysfunction. The frontal lobe, internal capsule, brainstem, and cerebellum commonly are involved sites. Initially, urinary retention due to detrusor areflexia is observed. This may be followed by detrusor hyperreflexia. Approximately 40-70% of patients with Parkinson disease have lower urinary tract dysfunction. Controversy exists as to whether specific neurologic problems in patients with Parkinson disease lead to bladder dysfunction or if bladder symptoms simply are related to aging. The extrapyramidal system is believed to have an inhibitory effect on the micturition center; theoretically, loss of dopaminergic activity in this area could result in loss of detrusor inhibition.

In patients with dementia, incontinence and urinary tract dysfunction may be due to specific involvement of the areas of the cerebral cortex involved in bladder control. Alternatively, incontinence may be related to global deterioration of memory, intellectual capacity, and behavior. Urodynamically, both detrusor hyperreflexia and areflexia have been found. In the case of neoplasms, CNS tumors of the superior medial frontal lobe, spinal cord tumors above the conus medullaris, and cervical spondylosis can cause detrusor hyperreflexia.

Other causes of urge incontinence

Bladder outlet obstruction is rare in females and, usually, is a post–incontinence surgery phenomenon. Advanced pelvic organ prolapse can cause a partial outflow obstruction. In older females with long-standing bladder control problems and pelvic organ prolapse, DI may coexist with a relatively poorly functioning detrusor. Due to poor contractility of the detrusor and partial obstruction related to advanced prolapse, the patient may experience incomplete emptying.

In males, early obstruction due to benign prostatic hyperplasia (BPH) may result in urge incontinence. BPH is a very common occurrence with aging and ongoing normal androgenic function. The pathophysiology of BPH is poorly understood. Relative obstruction develops due to mechanical factors, dynamic factors, and detrusor alterations. Androgen-induced enlargement of nodules of glandular tissue comprises the mechanical portion of the disorder. The dynamic component is related to increased alpha tone in prostatic and urethral smooth muscle. Detrusor dysfunction may consist of impaired contractility, DI, or both. In severe cases of obstruction, retention and overflow incontinence may develop, and the upper urinary tract can become damaged.

The presence of inflammation in the bladder is believed to result in bladder muscle irritability and urge incontinence in some instances (see Image 4). One study showed that approximately 8% of patients with bacterial urine infections had nonneuropathic bladder instability. If bacterial infection and DI coexist, successful treatment of the infection results in resolution of the DI in about one half of the patients. Nonbacterial inflammatory conditions of the bladder, including interstitial cystitis, have been associated with DI. Foreign bodies, including permanent sutures, bladder stones, and neoplasms, also have been linked to bladder irritability and instability.

Mixed incontinence is the term used when stress incontinence and DI coexist. Approximately 40-60% of females with incontinence have this combination. Although generally thought of as separate etiologies for incontinence, some indirect evidence may link these disorders in some instances. Some patients with mixed incontinence report stress incontinence symptoms first, followed in time with increasing urgency, and, finally, the appearance of urge incontinence. Many patients with stress incontinence alone as a urodynamic diagnosis also report urgency as a major symptom.

In some instances, surgery to support the UVJ cures the DI portion of mixed incontinence. In addition, some vaginal support devices designed to treat GSI have modest efficacy in the treatment of mixed incontinence. Some experts believe that funneling of the urethra, a lesion associated with stress incontinence, also may allow urine to contact the proximal urethra, resulting in a reflex detrusor contraction and DI. DI induced by coughing or the Valsalva maneuver frequently is observed during urodynamic evaluations, yielding the diagnosis of mixed incontinence.

Finally, the frequency with which the diagnoses of GSI and DI travel together is being studied. Several theories about the relationship between GSI and DI have been described. The most well-known theory involves urethral funneling and leakage of urine into the proximal urethra with triggering of urethral afferents. The result is the involuntary activation of the micturition reflex. The integral theory of incontinence states that a generalized laxity of the vagina and connective tissue support are at the root of most urinary incontinence. Similarly, other investigators believe that the stretching of pelvic nerves associated with pelvic organ prolapse may be involved in triggering involuntary detrusor contractions.

A shared pathophysiology between GSI and DI has not been proved, and, even if this relationship does exist, it may apply to only a subset of patients. Surgery for GSI is not contraindicated if the patient also has DI. At this time, the recommendation is that the surgical treatment of GSI in the setting of mixed incontinence be approached with caution. Both patient and physician must realize that DI may not improve and may even worsen. Participants should understand clearly that the surgery is intended to treat the stress incontinence component. One recent study demonstrated a better prognosis for surgical treatment if the urge incontinence symptoms clearly followed the stress incontinence symptoms in time. Although these findings are encouraging, for now, a conservative approach (ie, the treatment of mixed incontinence as 2 separate disorders) may be best. More research to further elucidate the relationship between stress and urge incontinence is needed.

Potential incontinence

Potential or masked incontinence refers to stress incontinence that is revealed only after a reduction of severe pelvic organ prolapse. Some believe that in these individuals, kinking of the urethra caused by the prolapse itself provides for at least part of the continence mechanism. In some patients, a history of stress incontinence with improvement and, finally, resolution coincident with worsening of the prolapse can be recounted. In diagnosing potential incontinence, the goal is to avoid new-onset incontinence following surgical correction of prolapse. In patients with potential incontinence, an incontinence procedure, such as a colposuspension or sling, should be considered. The diagnosis can be made by stress testing with the prolapse reduced or by pessary placement and pad testing. No particular method of prolapse reduction has been proved superior.

In a recent study using pessaries, 58% of the patients with severe pelvic organ prolapse had masked incontinence. These patients were treated with a pubovaginal sling, anterior colporrhaphy, and other appropriate reparative operations. Eighty-six percent of the patients with potential incontinence so treated had no postoperative stress-related urine loss. The group of patients with no demonstrable potential incontinence underwent anterior colporrhaphy and additional individualized procedures. Incontinence procedures, per se, were not performed in this group. No patients had postoperative stress incontinence. Mean follow-up was 40-50 months. This study points out that bladder neck procedures need not be performed if potential incontinence has been ruled out, even if bladder neck hypermobility is present. Indeed, incontinence procedures are not without their own morbidities and should not be performed unless necessary.

Overflow incontinence

Overflow incontinence is related most commonly to bladder neuropathy. Diabetes mellitus is a common etiology of the neurogenic bladder. Lumbosacral nerve disease from tumors, meningomyelocele, MS, and prolapsed intravertebral disks also can result in bladder neuropathy and overflow incontinence. High spinal cord injuries are another etiology. As discussed above, severe cases of outlet obstruction ultimately can cause severe retention, local neurologic injury, and overflow. In most cases, both sensory and motor neuropathy are present. The maximal physical capacity of the bladder is reached, often times without the individual realizing that this has occurred.

Incontinence occurs off the top of a chronically over-filled bladder. Effective emptying is not possible because of an acontractile detrusor muscle. In early bladder neuropathy, DI may coexist with a hypofunctioning detrusor muscle. Early in the course of diabetes-related bladder neuropathy, symptoms and the functioning of the detrusor may wax and wane. The result is periods when urinary retention and overflow incontinence are severe and periods when detrusor function and voiding effectiveness temporarily improve.

Continuous incontinence

This severe type of incontinence is characterized by constant or near constant leakage with no symptoms other than wetness. Generally, this represents some significant breech in the storage capabilities of the bladder or urethra. Urogenital fistulas are a classic example. A nonfunctioning urethra can result in continuous leakage. Scarring and fibrosis from previous surgery, partial urethral resection for vulvar cancer, and urethral sphincter paralysis due to lower motor neuron disease can cause the urethra to fail. In addition to being a possible etiology for fistula, pelvic irradiation rarely results in bladder noncompliance and continuous incontinence. Congenital malformations of the genitourinary tract, such as bladder extrophy, epispadias, and ectopic ureters, can result in total incontinence.

Functional incontinence

Functional incontinence is a term describing the inability to hold urine due to reasons other than neuro-urologic and lower urinary tract dysfunction. In some cases, the cause is of a transient nature. In other instances, a permanent problem can be identified. The etiology of the incontinence may be iatrogenic, environmental, situational, or disease related. A commonly quoted mnemonic is helpful in remembering the functional contributors to incontinence.

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Pediatric incontinence

Pediatric incontinence disorders are classified according to cause. Primary incontinence disorders generally are due to congenital structural disorders, including ectopic ureter, extrophy, epispadias, and patent urachus. Secondary structural causes can result from obstruction from urethral valves, congenital urethral strictures, and large ectopic ureteroceles. In addition, trauma can result in secondary structural incontinence.

Neurogenic lesions make up the next category of pediatric incontinence disorders. These include spinal dysraphism, tethered spinal cord, and spinal cord tumors. Nonstructural causes of incontinence can be related to infection and inflammation. Dysfunctional voiding habits can develop even at a young age. Some children may become so preoccupied with activities that voiding is delayed until capacity is reached and accidents result.

Some believe that certain children develop a pattern of not relaxing the pelvic floor while voiding. In some cases, this can be traced back to an infection or some other noxious stimuli. A vicious cycle of pelvic floor spasm, constipation, and urinary retention can develop. So-called giggle incontinence has been thought to represent an underlying temporal lobe seizure, but other studies do not support this theory. Vaginal voiding is a pseudoincontinence disorder, which may result from voiding with the legs too tightly together. The impeded flow of urine may fill the vagina. The vagina empties when standing.

Nocturnal enuresis is the most common pediatric incontinence disorder. The disorder occurs in 15% of children aged 5 years and in 1% of adolescents aged 15 years. Spontaneous resolution at a rate of 14-16% per year is the rule. This type of natural history makes the study of the etiology and treatment more difficult. Etiologic and pathophysiologic theories include decreased secretion of nighttime antidiuretic hormone, sleep disorders, delay in maturation of bladder control mechanisms, psychiatric disturbances, and allergies. A strong genetic component can be observed in some families. Indeed, a possible locus on chromosome arm 13q has been identified. Finally, some researchers believe that a weakness in urethral sphincteric function may exist due to poor alpha-sympathetic tone.

Integral theory

Recently, a unifying theory of the etiology of stress incontinence, DI, voiding dysfunction, and fecal incontinence has been proposed. The basis of the theory is that these disorders are the result of overstretching of the vaginal connective tissue and supporting ligaments, usually at the time of childbirth. Laxity of the pubourethral ligaments (ie, anterior zone of damage), mid vagina (ie, middle zone), and uterosacral ligaments (ie, posterior zone) make the usual tri-directional support of the vagina ineffective. With the vagina no longer properly tethered to the pelvic girdle, the usual neuromuscular actions that occur during increases in intra-abdominal pressure or pelvic floor relaxation during voiding are not translated as effectively into urethral closure and opening, respectively.

DI, according to this theory, occurs because of the premature firing of stretch receptors in the bladder base secondary to poor endopelvic connective tissue support to the filling bladder. The integral theory is attractive from the standpoint of parsimony but is complex. The theory is appreciated and understood best with the help of illustrations and diagrams showing directional force vectors. The interested reader is referred to the many publications by P.E. Petros, MD, on this subject.

Clinical:

History

The clinical presentation of urinary incontinence can be varied in many respects. Patient complaints may be minor and situational or severe, constant, and debilitating. When obtaining a clinical history, determining whether the problem is a social and/or hygienic problem and the degree of disability attributable to the incontinence also is important. In addition, the following points regarding the clinical presentation should be sought when obtaining the history:

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Incontinence histories can be very complex and time consuming. Most centers use some form of incontinence questionnaire as an aid. Sending the questionnaire to patients in advance so that they can give appropriate time and thought to their answers may be helpful. Part of the questionnaire should deal with the patient's quality of life, sexual and lifestyle issues, and the relationship of these factors to the incontinence disorder. The patient also should be instructed to fill out a voiding diary and to write down any questions. Voiding diaries should record the volume and type of fluid intake and the frequency and volume of voids. Episodes of nocturia should be noted. Finally, episodes of incontinence should be recorded, including an estimate of the volume; associated activities such as coughing, straining, and dish washing; and associated symptoms such as urgency.

Voiding diaries are helpful as a pretherapy diagnostic tool, but they also have been used to measure posttherapy outcomes. Voiding diaries are reproducible in the setting of stress incontinence, but fewer data exist regarding urge incontinence. In patients with stress incontinence, one study found that a representative and reproducible measure of incontinence episodes and mean daily voids can be obtained with a 3-day diary. A 1-day diary probably is too short. Further research is needed concerning voiding diaries in patients with urge incontinence.

Many cases of urinary incontinence present as a gradually progressive disorder. Progression from very mild symptoms to more severe and debilitating urine loss may take many years. The patient may come to medical attention only after experiencing a progressive worsening of symptoms. In other patients, symptoms may appear suddenly and may or may not be associated with a specific inciting event, such as pelvic/urinary tract surgery, trauma, and genitourinary tract infection. In these instances especially, associated symptoms such as pelvic pain, urgency, frequency, dysuria, and hematuria may point to a specific etiology. Most authorities agree that surgical therapy should not be based on history alone. A review of the role of patient history in the diagnosis of urinary incontinence showed that a history of stress incontinence carries a sensitivity of about 0.91, but specificity is only 0.51. Positive predictive values in the range of 0.75-0.87 have been reported for a history of stress incontinence.

Sensitivity and specificity are worse if the history is indicative of DI or mixed incontinence. Because some believe that many failed stress incontinence procedures are the result of incorrect or incomplete diagnoses, improving on the positive predictive value of history alone seems worthwhile.

The more difficult question to answer is which battery of tests and examinations produces a high positive predictive value at the lowest cost and inconvenience to the patient. One study looked at combining 4 factors to improve diagnostic accuracy. Patients with a predominant stress incontinence history, a postvoid residual (PVR) volume of no more than 50 mL, a positive cough stress test finding, and a functional bladder capacity of at least 400 mL underwent complex urodynamic testing. The diagnosis of stress incontinence was confirmed on urodynamic testing 97% of the time, but 15% of these patients also had coexisting DI. The positive predictive value, if one considers mixed incontinence as a separate disorder, is 82%. The essential issue seems to be the diagnosis of DI as a part of a mixed incontinence disorder; therefore, adding cystometry to the battery of necessary tests seems logical in most instances.

Physical examination

A focused physical examination should be performed. The examination is tailored somewhat in each case, based on the specifics of the patient's incontinence complaint and pertinent medical and surgical history. Each patient should have height, weight, blood pressure, and pulse recorded. Obesity is an important contributor to stress incontinence, and the presence of obesity may influence management decisions. Urinalysis and culture tests should be sent. Some practitioners have the patient arrive with a full bladder, measure the volume voided, and then catheterize the patient to obtain a PVR measurement. Others incorporate this into the urodynamics portion of the evaluation if this is to be performed.

The general physical examination is tailored to each individual patient. Medical illnesses and comorbidities that may be contributing to the overall incontinence disorder should be sought. Cardiac and pulmonary evaluation can be important. The abdomen should be examined for surgical scars, hernias, masses, and organomegaly. The presence of hernias may indicate inherent connective tissue weakness, a possible contributor to incontinence. Masses may contribute to stress incontinence and, occasionally, may cause obstructed voiding with resultant overflow incontinence. The back and costovertebral angles should be inspected and palpated. Tenderness, deformity, or the presence of surgical scars should prompt further investigation.

Because neurologic disorders can cause or exacerbate urinary incontinence, a focused neurologic examination should be a part of every incontinence evaluation. Much information can be gained from simple conversation with the patient (eg, mental status) and observation of gait (eg, CNS, spinal cord, peripheral nervous system disease). Any abnormalities should prompt more in-depth investigations. Strength, sensation, and deep tendon reflexes of the lower extremities should be tested. Sensation of the perineum and perianal area should be tested with a soft touch and light prick. Using a cotton swab, the anal wink pelvic floor reflex can be elicited by stroking laterally to the anal canal. The bulbocavernosus reflex can be elicited by gently tapping the clitoris with a cotton swab in the female patient. The presence of these perineal reflexes ensures that a significant pudendal neuropathy does not exist. The absence of these reflexes does not diagnose neuropathy but merely raises suspicion. These reflexes maybe extinguished if the patient is anxious during the examination.

The pelvic floor examination is an integral part of the incontinence evaluation. In female patients, in particular, incontinence disorders often coexist with pelvic floor relaxation. If a surgical approach to the incontinence is chosen, other pelvic floor defects of significance can be treated simultaneously. The examination begins with inspection of the external genitalia and urethral meatus. Evidence of atrophy, such as pallor and thinness of tissue, may indicate estrogen deficiency. A red, fleshy lesion of the posterior urethra, a caruncle, may be another indicator of urogenital hypoestrogenism. The suburethral area should be inspected and palpated. A suburethral mass should raise suspicion for a urethral diverticulum.

Other signs of a diverticulum might include tenderness and purulent or watery discharge upon compression. Urethral and trigonal tenderness also may indicate urethritis, urethral syndrome, or intersitial cystitis. The vaginal mucosa should be inspected for pallor, thinning, loss of rugae, and other signs of hypoestrogenism. If clinically suspected, a fistula opening may be discovered during vaginal examination. At times, pooling of fluid, exudate, or granulation tissue may indicate a nearby fistula tract.

A detailed pelvic floor examination should be performed for signs of pelvic organ prolapse. A systematic examination is conducted for cystocele, rectocele, uterine or vaginal prolapse, enterocele, and perineal laxity. A bivalve speculum should be used to visualize the cervix or vaginal apex. With the patient straining maximally, the speculum is withdrawn slowly, and any descent of the cervix or vaginal cuff is noted. The speculum is then disarticulated, and a single blade examination is performed, inspecting the anterior vaginal wall during straining with the posterior wall retracted. If a cystocele is observed, then a ring forceps or similar instrument is inserted over the speculum blade and opened to support the lateral vagina. The tips of the ring forceps should be against the bilateral ischial spines. If the cystocele is present with the patient straining and the lateral vagina supported, then a midline defect exists either in isolation or with a paravaginal defect.

Another clue to a midline defect is the loss of rugae with straining. If the cystocele is no longer present with lateral support, then a pure paravaginal defect is present. Another clue to paravaginal defects is collapsing side walls during bivalve speculum examination. If anterior wall prolapse is present with lateral support, then the next maneuver is to use the closed ring forceps to provide midline anterior vaginal support while the patient is straining again. If some cystocele is still noted, then a combined central and paravaginal cystocele is present. If no bulge is noted, then the defect is purely central.

Next, attention is turned to the posterior vaginal wall. The half speculum is used to retract the anterior wall of the vagina, while the posterior wall is examined during Valsalva maneuver. The presence or absence of a rectocele should be noted. If a double bump is observed when the patient strains, an enterocele may be present in addition to the rectocele.

Next, the perineal body is inspected. The height and thickness of the tissue is noted. A badly compromised perineal body may be short and consist of mostly skin with little or no underlying muscle. The levator muscles are palpated, and the resting tone is noted. Then, the patient is instructed to squeeze the examining fingers, and the levator strength can be appreciated. A rectovaginal examination is performed to determine the thickness of the rectovaginal septum. The patient then is asked to strain. Tissue felt sliding through the examining fingers may indicate an enterocele. Resting and squeezing rectal sphincter tone is noted. As the rectal finger is withdrawn, the external anal sphincter should be palpated between this finger and the thumb. The absence or attenuation of this body of muscle indicates a sphincter laceration. In the male patient, levator ani tone and strength can be tested during a rectal examination. The prostate should be palpated looking for tenderness, enlargement, and nodularity.

Cotton swab test

This part of the examination assesses urethral mobility. A lubricated sterile cotton swab is placed through the urethra and into the bladder. The swab is pulled back until increased resistance is met, indicating that the cotton tip is entering the urethra. At this point, the patient is asked to strain maximally. The change in angle, indicated by the arc of the wooden end of the swab, is measured with a goniometer or estimated visually. A change of greater than 30 degrees indicates urethral hypermobility. Positive findings provide no specific diagnosis.

Hypermobility is present in most cases of stress incontinence. If hypermobility is not present and stress incontinence is diagnosed, ISD should be suspected. In this setting, an operation designed solely to stabilize the UVJ may not be the best choice. When performing the cotton swab test, having the patient put forth a maximal effort is important. The examiner should not use a posterior vaginal retractor. The labia should be parted if the tissue is touching the wooden shaft of the swab because this may impair movement during straining.

Stress testing

Stress testing should be performed with a full bladder. This author performs the test in both the lithotomy and standing positions. In either case, directly visualizing the urethra is necessary. The patient then is asked to cough forcefully and repetitively. Alternatively, the patient may perform a strong Valsalva maneuver. Urine loss directly observed from the urethral meatus at the peak of the increase in intra-abdominal pressure is strongly suggestive of stress incontinence (see Image 5).

Generally, the patient with stress incontinence displays immediate urine loss of relatively short duration. A few drops to a squirt of urine characteristically is lost. Delayed loss or prolonged loss raises the question of stress-induced DI. If no urine loss is observed, the test can be repeated in another position or repeated at another date. If more than mild pelvic organ prolapse is present, reduction of the prolapse should be performed with a half speculum, a pessary, or the examining fingers during the stress test. Care must be taken not to compress the urethra, regardless of which reduction method is employed.

Positive stress test findings in the supine position with a relatively empty bladder and with position change or other minimal increases in intra-abdominal pressure raise the question of ISD. Complex urodynamic testing would be indicated. Pyridium pad testing can be used if the history strongly suggests stress incontinence, stress test findings are negative, and DI is ruled out. This particular test is discussed in detail in a subsequent section.

Marshall-Bonney test

Stress testing with support rendered to the hypermobile urethra has been used for decades to attempt to predict the success or failure of stress incontinence operations. The test has been criticized because it is imprecise and may work, in part, through urethral compression. A number of different methods have been described to perform elevation and support of the UVJ, including ring forceps, examining fingers, large cotton-tipped swabs, and specialized instruments. Data do not exist to recommend one method over another definitively. Urodynamics studies conducted while performing a modification of the Marshall-Bonney test revealed an average increase in urethral pressure of 52 cm H2O, compared to greater than 250 cm H2O with direct urethral compression. In this study, large cotton swab tips attached to short ring forceps were used to elevate the UVJ. Cough pressure transmission ratios increased from 64% before the test to 152% during the test.

A recent review article stated that the test may be useful if the findings are negative (ie, incontinence persists despite support to the hypermobile urethra). This author believes that these findings might dictate a more aggressive surgical approach, such as performing a sling procedure rather than a Burch retropubic urethropexy. This author also believes that this test has a place in planning incontinence therapy, although the performance of this test is purely within the realm of the art (ie, not the science) of incontinence evaluation.

Grading urinary incontinence

The results of the history and physical examination provide the clinician information that guides the ongoing evaluation. Part of the information available at this point is an estimation of the degree of incontinence experienced by the patient. In the 1970s, Stamey devised a grading system based on the degree of incontinence. Such a system, as outlined below, can prove to be useful in both the clinical and research settings.

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INDICATIONS ¡@

Nonsurgical treatment for urinary incontinence may be initiated whenever the patient believes that the problem warrants attention. Most authorities believe that treatment in these patients can be based on history, a physical examination, and urinalysis to rule out infection. A confirmation of the diagnosis by urodynamic studies need not be performed before initiating noninvasive treatment. Primary care physicians should be able to begin treatment in this way in a large number of patients. Referrals to a specialist should be reserved for patients with severe or continuous incontinence, complicated medical or surgical histories, or treatment failures and for those patients contemplating surgery.

Surgical treatment of stress urinary incontinence is indicated if the patient desires surgical correction, if the problem is perceived as a significant social and/or hygienic problem, and the incontinence is demonstrable and of a type that is amenable to surgery. The diagnosis should be based on the results of at least a minimum of studies, as follows:

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More complicated urodynamic testing should be performed, if indicated, before surgical treatment. In particular, the diagnoses of ISD, mixed incontinence (ie, stress, urge), and voiding dysfunction should be kept in mind because any of these can influence the choice of procedure and complicate surgical management. In addition, in patients with no urinary incontinence complaints who are to undergo surgery for pelvic organ prolapse, the diagnosis of potential incontinence should be sought. Stress testing with the prolapse reduced or a trial of pessary management may reveal this diagnosis. If these test findings are positive, an incontinence procedure should be considered as part of the overall corrective surgical therapy.

Controversy exists as to whether patients should undergo a trial of nonsurgical management before consideration for incontinence surgery. Some authorities believe that nonsurgical management should be tried in most patients because the risks are minimal and the potential gains and cost savings are great. Others believe that an informed patient with a severe degree of incontinence, after appropriate workup, can be offered surgical management at the outset.

ISD, as demonstrated through urodynamic testing, generally is an indication for surgical management. ISD with a fixed or nonmobile urethra can be approached by periurethral bulking injections, an artificial sphincter, or an obstructive suburethral sling. If the urethra is simultaneously hypermobile, a suburethral sling is the ideal choice. Periurethral bulking agents also may be appropriate in this setting. GSI procedures, such as the retropubic urethropexy, may have higher failure rates when ISD also is present. The use of periurethral injections as the initial management does not preclude the use of the other described modalities if it should fail. Conversely, if satisfactory results are not obtained with a urethra-stabilizing procedure, periurethral injections can be added as a secondary procedure.

DI rarely is an indication for surgical treatment of incontinence. On occasion, in cases of mixed incontinence, the DI portion of the disorder may improve or resolve completely after a procedure for GSI. Nevertheless, the GSI diagnosis was the true indication for surgery. In rare instances, DI that is refractory to pharmaceutical, behavioral, and other nonsurgical management may be treated by surgery. Few data exist on the efficacy of surgery in this setting, and results often are less than ideal. Procedures have been described to partially denervate the bladder and to augment or autoaugment bladder capacity. Urinary diversion is a procedure of last resort. Recently, surgically implantable sacral neuromodulating devices have been used with some success in refractory cases. Urogenital fistulas usually require surgical management, especially if the fistula is more than pinpoint in size. Bladder drainage alone is successful in some cases of very small fistulas.

RELEVANT ANATOMY AND CONTRAINDICATIONS ¡@

Relevant Anatomy:

Anatomy of the urethra, bladder, and retropubic space

Detailed knowledge of the anatomy of the retropubic space, the potential space between the pubic bone and the bladder, must be mastered by the incontinence surgeon. Ventrally, the retropubic space is bounded by the pubic bones and the midline fibrocartilage. The floor and part of the dorsal aspect are comprised of the bladder, urethra, and the endopelvic connective tissue, which extend laterally on both sides to the pelvic side walls at the arcus tendineus fasciae pelvis (ATFP). The remainder of the dorsal wall consists of the pelvic parietal perineum and the transversalis fascia. Above the arcuate line, the posterior rectus sheath is present. As originally described by Retzius, the potential space extends in a cephalad direction to the level of the umbilicus.

The pectineal ligament, or Cooper ligament, lies on the superior-dorsal surface of the pubic ramus. A flat triangular extension of Cooper ligament, the lacunar ligament, widens as it travels medially and joins the inguinal ligament at the pubic tubercle. The anterior or ventral aspect of the bladder makes up the floor of the retropubic space. This part of the bladder wall is extraperitoneal in location.

The cephalad wall and part of the posterior wall are covered with peritoneum and can be accessed from within the peritoneal cavity. The inferior aspect of the bladder lies on the anterior vagina, cervix, and lower uterine segment. The tissue between the bladder and the muscular wall of the vagina is the endopelvic connective tissue. Lateral to the bladder and bladder neck and within the endopelvic connective tissue lies a venous plexus. These prominent veins are a frequent source of bleeding during retropubic urethropexy. The pubovesical ligaments, pubourethral ligaments, and the extrinsic muscles of the urethra also lie in the retropubic space.

The bladder wall is made up of muscle fibers extending in all directions. This configuration is well suited to decreasing the bladder size in all dimensions when contracting. At the bladder neck, the muscular bladder wall is more organized, and 3 relatively distinct layers become apparent. The inner longitudinal layer fuses with the inner longitudinal layer of the urethra. The middle circular layer is most prominent in the proximity of the bladder neck, and it fuses with the deep trigonal muscle. The outer longitudinal layer contributes some anterior fibers to what becomes the pubovesical muscles, terminating on the posterior surface of the pubic bone. These muscles may be important in bladder neck opening during micturition. Posteriorly, the outer longitudinal fibers interdigitate with deep trigonal fibers and the detrusor muscle. These fibers may aid in bladder neck closure.

The bladder mucosa is transitional epithelium, which is loosely connected to the muscular wall by way of a connective tissue layer called the lamina propria. At the trigone, the epithelium is more densely adherent to the underlying muscle. The trigone is a triangular structure formed by the internal urethral opening and the orifices of the right and left ureter. The superior border of the trigone is a raised area called the interureteric ridge. Deep to the mucosa are 2 muscular layers. The superficial layer connects to longitudinal urethral musculature. The deep muscle fuses with detrusor and Waldeyer sheath, the fibromuscular covering of the intramural ureter. The intramural ureter enters the bladder wall obliquely. The muscle fibers are longitudinal in orientation at this point. This segment of the ureter is about 1.5 cm in length.

The urethra is approximately 4 cm long in the female. It is imbedded in the connective tissue supporting the anterior vagina. The epithelium is comprised of stratified squamous cells, which variably becomes transitional as the bladder is approached. The epithelium is arranged in longitudinal folds. At the base of the folds are scattered gland openings along the entire urethral length. The epithelium is supported by a loose lamina propria consisting of collagen fibrils and elastic fibers, arranged both circularly and longitudinally. A rich network of blood vessels is in the subepithelial layer.

The smooth muscle of the urethra is arranged longitudinally and obliquely with only a few circular fibers. The nerve supply is cholinergic and alpha-adrenergic. The longitudinal muscles may contribute to shortening and opening of the urethra during voiding. The oblique and circular fibers contribute to urethral closure at rest.

The striated urethral musculature is complex, and the components and their orientation are not agreed upon universally. The voluntary urethral sphincter really is a group of circular and looplike interrelated muscle fibers, similar to that present in the anorectum. The innermost layer, which is prominent in the proximal two thirds of the urethra, is the sphincter urethrae. More distally, the compressor urethrae and urethrovaginal sphincter are predominant.

These 2 muscles emanate from the anterolateral aspect of the distal half to one third of the urethra and arch over the anterior or ventral surface. These striated muscles function as a unit. Because they are composed primarily of slow-twitch muscle fibers, these muscles serve ideally to maintain urethral tone. The muscles probably do maintain the urethral tone but contribute to voluntary closure and reflex closure of the urethra acutely during times of increased intra-abdominal pressure. The medial-most pubovisceral portion of the levator ani complex also is a major contributor to active bladder neck and urethral closure.

Histologic examination of the striated urethral sphincter indicates that, for the most part, the muscle complex surrounds the urethra in an incomplete fashion. Fibers can be observed to be deficient along the posterior aspect of the urethra. The shape of the muscle complex can be described as resembling a horseshoe or an omega symbol. Recent investigations using US imaging of the urethra also have confirmed a paucity of muscle bulk along the posterior urethra. The urethral meatus empties into the vestibule after the distal-most urethra pierces the perineal membrane. The mucosa of the meatus is continuous with that of the vulva. Support of the urethra and bladder neck is believed to be important in the maintenance of continence during sudden increases in intra-abdominal pressure. The support mechanism is complex and incompletely understood.

The posterior wall of the urethra is imbedded in and supported by the endopelvic connective tissue. This sheet of connective tissue consists of collagen, elastin, and a small amount of smooth muscle. The connective tissue envelops the anterior vagina. This supportive tissue has been likened to a sling or a hammock around the urethra and bladder neck. The endopelvic connective tissue in this area is attached to the perineal membrane ventrally and laterally to the levator ani muscles by way of the ATFP. The ATFP is a condensation of connective tissue, which extends bilaterally from the inferior part of the pubic bone along the junction of the fascia of the obturator internus and levator ani muscle group to an area near the ischial spine. This tissue provides secondary support to the urethra, bladder neck, and bladder base.

Defects in this tissue are believed to result in cystocele and urethral hypermobility. The primary support to this area and the entire pelvic floor is believed to be the levator ani muscles. At rest, the constant tone mediated by slow-twitch fibers constitutes the major supportive mechanism. With acute increases in intra-abdominal pressure, forceful contraction of the fast-twitch levator fibers elevates the pelvic floor and tightens intact connective tissue planes, thereby supporting the pelvic viscera.

The anterior distal wall of the urethra is attached to the pubic bone by the pubourethral ligaments. These ligaments consist of extensions of the perineal membrane and the caudal and ventral-most portion of the ATFP. The ligaments may limit movement of the anterior wall of the urethra during increases in intra-abdominal pressure but probably exert a lesser degree of support to the posterior wall. The previously described endopelvic connective tissue, when intact, provides support to the urethra as a whole. With increases in intra-abdominal pressure, some believe that the urethra is compressed shut against this firm support.

Deficiency in the hammocklike support of the endopelvic connective tissue, coupled with relative preservation of the preferentially anterior urethral support of the pubourethral ligaments, may partially explain the complex rotational and descending motion of the bladder neck commonly observed in association with stress incontinence. The pubourethral ligaments may serve to limit downward motion of the anterior urethral wall and provide a pivot point for rotatory motion around the pubic bone. Some theorize that this preferential anterior wall support also may serve to pull the anterior and posterior urethral walls apart during straining, thereby contributing to bladder neck incompetency and stress incontinence.

The intrinsic male urethra is considerably longer and somewhat more complex than its female counterpart. Distal to the bladder neck, the segment of the urethra that traverses the prostate is called the prostatic urethra. The epithelium is transitional. The orifices of the prostatic glands can be found here. On the floor of the prostatic urethra is an elevation called the verumontanum. This area contains a small pocket called the utricle. Distal to the utricle are the orifices of the 2 ejaculatory ducts. Continuing distally, the membranous urethra is encountered. This short segment traverses the urogenital diaphragm. Cowper glands are adjacent to the urethra. The epithelial cells become more elongated and appear as stratified columnar cells. The bulbous urethra derives its name from the bulb of the corpus spongiosum, which it traverses. The ducts of the Cowper glands empty in this location. The epithelium is comprised of pseudostratified columnar cells.

The penile urethra passes through the remainder of the corpus cavernosum urethrae and makes up more than half of the total anatomic urethral length. The epithelium is comprised of pseudostratified columnar cells, except in the fossa navicularis, the slightly widened distal part of the urethra that passes through the glans penis. In this distal-most segment, stratified squamous epithelium is present. Throughout the penile urethra, the periurethral tissue contains many small mucus-secreting glands, called the glands of Littre. These glands are much more numerous along the roof of the urethra, and they empty into small recesses called the lacunae of Morgagni. The bulbous and penile urethra together sometimes are referred to as the cavernous urethra.

Neuroanatomy of the lower urinary tract

Intact neuroanatomic and neurophysiologic functions are essential to both the storage and micturition phases of lower urinary tract function. These functions are controlled largely by the peripheral autonomic nervous system, with important modulating information contributed by sensory nerves from the bladder and urethra. Further modification is provided by higher CNS centers, which allow conscious control of lower urinary tract function. Lesions can occur anywhere along the neuroanatomic pathways, which can contribute to or cause incontinence or voiding dysfunction.

Voluntary control of detrusor activity is thought to arise in the frontal cerebral cortex. This area is in communication with the pontine mesencephalic reticular formation, which serves as the brainstem micturition center. Maturation of these and higher centers are important in the childhood acquisition of the ability to voluntarily suppress micturition. Diseases that involve this area of the brain may cause or contribute to incontinence disorders. Stroke, MS, Parkinson disease, and brain tumors are examples.

Efferent connections beginning in the pons and terminating in the sacral micturition center at the S2 to S4 levels are important to efficient detrusor functioning during micturition. Damage to these tracts (eg, spinal cord injury) results in detrusor areflexia. Neural activity within this system promotes micturition. A neural loop involving the bladder, sacral micturition center, pontine micturition center, and urethral sphincter mechanism has been described. This pathway allows the coordination of urethral and detrusor function. In other words, coordination of urethral relaxation with detrusor contraction is dependent on this neural pathway being intact.

Dysfunction in this loop may result in detrusor-sphincter dyssynergia. Direct connections between the cerebral cortex and the sacral-pudendal motor neurons are important contributors to voluntary control over the striated urethral-sphincter complex. Severe neuromuscular damage to the striated urethral muscles, along with brain and spinal cord injury, can prevent proper functioning of this system.

Healthy functioning of the lower urinary tract is partly dependent on the interplay of sympathetic (ie, adrenergic) and parasympathetic (ie, cholinergic) input to the bladder and urethra. Bladder filling normally takes place with little or no increase in intravesical pressure. This phenomenon is largely due to the predominance of sympathetic tone during the filling and storage phase. Simplistically, beta-adrenergic receptors predominate in the detrusor muscle.

Stimulation of these receptors promotes bladder relaxation. Alpha fibers also exist, in smaller numbers, in the parasympathetic ganglia supplying the bladder. Stimulation of the alpha fibers results in the inhibition of neural firing at the level of the parasympathetic ganglion, thereby inhibiting bladder contractions. Alpha-adrenergic receptors predominate in the smooth muscle of the bladder neck and urethra. Stimulation results in contraction of the structures. The sum effect of sympathetic stimulation of the bladder and urethra is the promotion of storage. Parasympathetic or cholinergic stimulation generally is micturition-promoting.

Postganglionic muscarinic fibers to the detrusor muscle promote bladder contractions when stimulated. In addition, stimulation of muscarinic receptors on alpha-adrenergic nerves to the urethra prevents norepinephrine stimulation. The resulting physiologic effect is urethral relaxation. Cholinergic agents, although generally thought of as promoters of detrusor activity, also can stimulate preganglionic sympathetic nicotinic receptors with neural connections to the urethra and bladder neck. Such stimulation promotes contraction of these structures.

Nonadrenergic, noncholinergic nerves with ATP-stimulated purinergic receptors have been found in animal models and in the human bladder. These nerves may be very important in bladder contractility. Prostaglandins also may be able to activate these receptors. Sensory afferent innervation of the bladder originates with stretch and pain receptors in the bladder wall. Stretch receptors, which are responsible for bladder proprioception, are the origin of impulses traveling via the pelvic nerve to the posterior columns ipsilaterally and, eventually, the brain stem micturition center. Connections from the brain stem to the cerebral cortex provide for conscious awareness of bladder distention.

Pain receptors are present in the bladder wall but not as densely as stretch receptors. These receptors are responsible for sensing temperature, touch, and irritative stimuli. The generated impulses travel by way of the hypogastric nerve to synapse in the posterior root ganglia. The impulses cross to the contralateral side before ascending in the spinothalamic tract and the thalamic nuclei, eventually reaching the cerebral cortex. Afferent impulses from these receptors can trigger detrusor contractions via a normally suppressed reflex arc. Under conditions of severe mucosal irritation (eg, UTI), this reflex may become unmasked. In addition, disorders resulting in the loss of conscious cerebral cortical input may be responsible for the emergence of this reflex.

Somatic efferent innervation to the striated urethral sphincter complex is from the second through the fourth sacral segments. The precise source of these fibers is controversial. Evidence suggests that the sphincter complex is innervated by way of the pelvic nerve rather than the pudendal nerve, as was once thought. The levator ani complex probably has a dual source of innervation from both the pelvic and pudendal nerves.

Estrogen receptors can be found in the musculature of the pelvic floor, bladder, bladder neck, and urethra. Estrogen stimulation increases the density of alpha-adrenergic receptors in the urethral smooth muscle. Progesterone may enhance beta-adrenergic activity. Emerging evidence of the presence of gonadotropin receptors in the lower urinary tract also exists.

Contraindications: Contraindications to incontinence surgery are few and, generally, are relative rather than absolute (eg, conditions that make general or regional anesthesia risky). In some instances, in the face of serious medical problems, nonsurgical therapies or minimally invasive surgical approaches, such as periurethral injections, can be substituted. Sensory and/or motor impairment of the bladder with coexisting stress incontinence should be approached with caution. Procedures that increase outlet resistance most likely make these conditions worse. Severe urinary retention may result. In these situations, if stress incontinence surgery is to be undertaken, instructing the patient in self-catheterization techniques is best conducted preoperatively. In patients with high-pressure bladders due to loss of compliance, some type of augmentation procedure should be performed at the time of incontinence surgery to reduce the potential for damage to the upper urinary tract.

WORKUP ¡@

Lab Studies:
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Imaging Studies:
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Other Tests:
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Diagnostic Procedures:
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TREATMENT ¡@

Medical therapy: Medical therapy of stress urinary incontinence can include pharmacology therapy, behavioral therapy, biofeedback, pelvic floor conditioning, pelvic floor stimulation, bladder training, use of pessaries or occlusive devices, lifestyle modification, ISC, and treatment of medical comorbidities. Each of the therapies is discussed. In some instances, combinations of 2 or more therapies prove beneficial. Some types of incontinence (eg, DI) are more amenable to medical therapy than other types (eg, GSI). Some experts recommend a trial of medical therapy before considering surgical treatment. Others believe that if the incontinence is severe and correctable by surgical means, a trial of medical therapy is not mandatory and does not need to be performed if the informed patient chooses to proceed directly to surgery.

Pharmacologic therapy

Alpha agonists, such as phenylpropanolamine (recalled from US market), may improve symptoms of mild stress incontinence by increasing intrinsic urethral tone due to effects on the urethral sphincter. A slow-release form dosed at 75-100 mg daily can be used. Imipramine, which has both alpha-agonist and anticholinergic effects, has been shown to have moderate efficacy (60-71%) in treating stress incontinence. Imipramine appears to work by increasing both urethral closure pressure and functional urethral length. High pretreatment urethral closure pressure served as a predictor of success.

Estrogen therapy may have several positive effects in patients who are estrogen deficient with stress incontinence. Estrogen may increase the density of alpha-receptors in the urethra. In addition, the vascularity of the urethral mucosa is increased and the coaptive abilities of the urethral mucosa may be augmented. Estrogen therapy is used best as an adjunct to other medical treatments or surgery. As a sole treatment modality for GSI, studies have shown that estrogen therapy has either no or only marginal clinical benefit. Local urogenital treatment provides more rapid and reliable effects and may be especially helpful as a preoperative adjunct.

Discontinuing alpha-blockers and ACE inhibitors may be beneficial in patients who are taking these agents and have mild GSI. Discontinue only if safe and if effective alternative medications can be substituted. Appropriate consultation is recommended before initiation of any medication changes.

Pelvic floor rehabilitation

Kegel exercises have been shown to improve the strength and tone of the muscles of the pelvic floor. During times of increased intra-abdominal pressure, tensing of these muscles tightens the connective tissue supports surrounding the urethra. Thus, pressure transmission to the urethra may increase, and the urethra compresses shut during times of increased stress. The exercises consist of voluntary contractions of the muscles of the pelvic floor. Because both fast-twitch and slow-twitch muscle fibers are found in the levator ani complex, both rapid contractions and slow contractions held for maximal duration should be performed to achieve the best possible results. If instructions for Kegel exercises are provided verbally or in written form alone, a significant percentage of individuals perform repetitive Valsalva maneuvers or gluteal contractions. Therefore, instructing the patient in the examining room by having her squeeze the examiner's intravaginal or intrarectal finger is important.

The patient can confirm that she is using the correct muscles at home by periodically performing the contractions during voiding with the goal of interrupting the urinary stream. The number of daily contractions needed to achieve optimal efficacy is unknown, but, at a minimum, probably 3-5 sets of 10 exercises are required. Approximately 6-12 weeks of exercises are required before improvement is noted, and 3-6 months are needed before maximal benefit is reached. Patients with severe neuromuscular damage to the pelvic floor may not be able to perform Kegel exercises even with proper instruction.

Vaginal cones are weighted devices designed to increase the strength of the pelvic floor muscles. Typically, the cones are retained for 15 minutes twice a day, and the weight of the cones is gradually increased. Although probably no more efficacious than properly performed Kegel exercises, this method may be preferred by some individuals.

Biofeedback in the form of visual or auditory signals may be an effective method of exercising the pelvic floor. The responses may provide incentive and confirmation of proper performance of the muscle contractions. Efficacy rates of 50-85% have been demonstrated. Electrical stimulation of the pelvic floor can be achieved with a vaginal or rectal probe. Low-frequency electrical pulses of 50-100 Hz are used. This method can be useful in treating individuals who desire therapy via pelvic floor rehabilitation but have difficulty performing pelvic muscle contractions on their own. Improvement rates of close to 90% have been reported.

Extracorporeal magnetic resonance therapy has been introduced recently into the therapeutic armamentarium for stress incontinence. The NeoControl unit (Neotonus, Marietta, Ga) recently was approved by the Food and Drug Administration (FDA) for this purpose. Resonating magnetic flux within a magnetic field induces electrical depolarization of targeted nerves and muscles. No probes are required. The patient simply sits on a chair containing the magnetic device. A small study achieved an improvement rate of 77% after 8 weeks of therapy, with 56% of patients being completely dry.

Prosthetic devices

The Impress Softpatch (UroMed Corporation, Needham, Mass) is an adhesive foam patch designed for a single use. A hydrogel adhesive anchors the patch over the urethral meatus. In one study, 52% of women with mild-to-moderate stress incontinence were dry, and 82% were improved with the use of this device. The Reliance Urinary Control Insert (UroMed Corporation, Needham, Mass) is a small catheterlike device that is inserted into the urethra. The balloon is inflated with air. The single-use device is removed before voiding by pulling on an attached thread. Approximately 80% of patients are dry with the use of this insert, with an additional 12% greatly improved. Complications such as migration into the bladder and UTI have been reported.

The FemAssist (Insight Medical Corporation, Boston, Mass) and CapSure Shield (Bard Urological, Covington, Ga) are silicon devices that seal the urethral meatus with an action similar to a suction cup. These devices can decrease significantly the urine loss in short-term pad test studies. In a more extended study of the device, only 2 of 31 women finished a 6-month trial. Reasons cited for drop out were lack of efficacy, poor adhesion, discomfort, and difficulty placing the device. This study points out that short-term results in highly motivated individuals may not be generalized to longer-term use under real-life circumstances.

The Introl Bladder Neck Support Prosthesis (UroMed Corporation, Needham, Mass) is an insertable vaginal device with arms that provide support on each side of the bladder neck. If properly fitted, the prosthesis can achieve cure rates of approximately 80% for stress incontinence. Incontinence pessaries also are available for use in mild stress incontinence. These ring- or dish-shaped devices usually are reinforced in the area that sits under the bladder neck/proximal urethra. A modicum of success has been achieved with these specially designed pessaries.

Behavioral approaches

Timed, frequent voiding can be employed to minimize incontinence, especially if the bladder is kept empty before incontinence-producing activities. Symptoms of urgency and frequency can develop over time with this strategy due to decreased bladder capacity. Anticipatory pelvic floor contractions can be taught to patients to cut down on incontinence episodes. The patient is taught to perform a strong pelvic floor contraction just before anticipated episodes of increased intra-abdominal pressure, such as a cough or a sneeze. Modifying activities occasionally can be a solution to incontinence-related specific activities. For example, if a woman experiences incontinence only during high-impact aerobics, substitution of another fitness activity, such as swimming, may solve the incontinence problem.

Treatment of medical comorbidities

As previously discussed, disease treatment, including weight loss, smoking cessation, control of asthma, and chronic constipation, may minimize incontinence episodes. A few studies show significant decreases in urinary incontinence in small cohorts of women experiencing weight loss. For the most part, these women underwent obesity surgery. In a study of 138 patients who lost 50% or more of their excess body weight, stress incontinence dropped from 61% to 11%. In another smaller study of 12 women with morbid obesity, 9 had relief of stress incontinence after obesity surgery. Presumably, nonsurgical methods of weight loss could lead to similar benefits. Weight loss as an adjunct to incontinence surgery has not been studied specifically but often is recommended.

Medical management of detrusor overactivity

Management options include pharmacologic, behavioral, and electrical stimulation. These options may be tried sequentially, but combined approaches often work best. Idiopathic DI (ie, nonneuropathic) is more amenable to medical approaches than detrusor hyperreflexia (ie, neuropathic). The latter often may require a more invasive surgical approach. Clinically significant improvement in DI can be expected in approximately 80% of the cases using one or more of the described medical approaches.

Anticholinergic agents

The clinical and urodynamic effects of blocking cholinergic receptors in the bladder are to increase bladder capacity, increase the volume threshold for initiation of an involuntary contraction, and decrease the strength of involuntary contractions. Propantheline bromide is an anticholinergic agent that has been used to treat DI. Propantheline commonly is prescribed in dosages of 15-30 mg every 4-6 hours. Because gastrointestinal absorption is poor, many recommended that propantheline be taken on an empty stomach. Typical anticholinergic adverse effects can be expected, including dry mouth, constipation, dry eyes, blurred vision, orthostatic hypotension, and increased heart rate. This agent probably should be avoided by patients with heart disease and closed-angle glaucoma. Improvement rates in various studies generally have been approximately 50%. Propantheline is no longer considered a first-line drug for DI due to relatively poor efficacy and a high incidence of adverse effects.

Tolterodine tartrate is the newest drug approved for the treatment of DI. This drug is a potent antimuscarinic agent. In animal models, the drug has shown selectivity for the urinary tract over the salivary glands. Tolterodine has performed well in clinical trials, showing comparable efficacy to oxybutynin with lower discontinuance rates. The dosage range is 1-2 mg twice daily. Two small studies examining the use of transdermal scopolamine in the treatment of DI recently were reported. The results of these studies are conflicting in terms of both efficacy and tolerability of adverse effects.

Tricyclic antidepressants

These drugs have complicated direct and indirect effects on the lower genitourinary tract. They possess both a central and peripheral anticholinergic effect. Tricyclic antidepressants also are alpha-adrenergic agonists and central sedatives. The resultant clinical effect is bladder muscle relaxation and increased urethral sphincter tone. The pharmacological effects make these drugs good choices for mixed incontinence, nocturia, and nocturnal enuresis. Imipramine is the most widely used tricyclic for urologic indications. The dosage range is 25 mg 2-4 times per day.

In addition to anticholinergic adverse effects, serious allergic reactions have been reported, although rarely. Cardiotoxicity rarely is problematic at the low doses used for treatment of DI. Central effects, such as sedation and tremor, may be troublesome to some patients. On occasion, this author has found prescribing imipramine at bedtime and a musculotropic agent in the daytime to be useful. Studies have demonstrated an approximate cure rate of 60% in individuals with DI.

Musculotropic relaxants

Musculotropic relaxants depress smooth muscle activity directly but at a site distal to the cholinergic receptor. Relaxants also may work, in part due to anticholinergic and local anesthetic properties at the level of the bladder. Oxybutynin is the prototype drug in this class. The typical dosage is 5 mg 2-4 times per day. Adverse effects are related mostly to the anticholinergic effects. Lower dosages, such as 2.5 mg 2-3 times a day, may be more appropriate for elderly patients.

Good-to-excellent results have been obtained in clinical trials, with improvement rates ranging from 61-86%. Oxybutynin is available in syrup and extended release formulations. The extended release form is dosed 5-15 mg once daily and is of comparable efficacy to the parent drug. One study used specially prepared oxybutynin suppositories in patients who were intolerant of anticholinergic adverse effects when taking the oral form. Most of these patients were elderly. Adverse effects via this route of administration were less, but the overall symptomatic improvement rate was only 48%.

Flavoxate hydrochloride is a direct smooth muscle relaxant with very weak anticholinergic properties. Few adverse effects are associated with its administration, but efficacy has been questionable. An observational study of flavoxate use in clinical practice described good results in decreasing daytime and nighttime urgency and the number of voids, but urge incontinence was not examined. The usual dosage is 100-200 mg 3-4 times per day.

Dicyclomine hydrochloride is a smooth muscle relaxant that has been used most commonly to treat irritable bowel syndrome. Moderate efficacy has been reported with a dosage of 20 mg taken orally 3 times daily. Adverse effects mostly are anticholinergic.

Calcium channel blockers

Terodiline was once a very popular drug for the treatment of DI in Europe but has since been withdrawn from the market due to a potential for serious adverse cardiac effects. In a small study, verapamil was no more effective than the placebo and less effective than oxybutynin. Verapamil combined with oxybutynin was more effective than oxybutynin alone. A small study showed magnesium hydroxide beneficial for some patients with sensory urgency and DI. The presumed mechanism of action is through calcium antagonism. More work is needed before this treatment is recommended.

Potassium channel openers

This class of drugs relaxes smooth muscle by increasing potassium efflux, with resultant membrane depolarization. Researchers who found supersensitivity of the detrusor muscle to depolarizing stimuli, such as potassium, in individuals with urge incontinence provides the theoretical basis for the use of these agents in patients with DI. One problem in the development of potassium channel openers for use in bladder disorders has been the lack of organ specificity.

Prostaglandin inhibitors

Prostaglandins may have an excitatory role in bladder contractility. Prostaglandin inhibitors, in theory, may block bladder contractility. Clinical trials with agents, such as indomethacin, have shown mixed and generally not impressive results. One research group reported evidence of the role of a relative prostacyclin deficiency in the promotion of bladder contractions. Pharmacotherapy to increase the ratio of prostacyclin to other prostaglandins has not been investigated to date.

Beta-adrenergic agonists

These agents relax beta-adrenergic receptors that contain smooth muscle. Such receptors exist in the human bladder. Studies of terbutaline and clenbuterol have yielded mixed results. The role of these drugs as adjuncts to other pharmacologic therapies has not been explored.

The agent 1-desamino-8-D-arginine vasopressin (DDAVP) has been used in children with nocturnal enuresis with good results. The hormone causes water to be reabsorbed from the renal collecting system. Reduction in nighttime urine production may be beneficial in patients with DI and a significant degree of nocturia. Caution is needed when using this drug in elderly patients. Do not use in patients with significant CHF and in children younger than 5 years (eg, water intoxication).

Estrogen

Sensory-urgency symptoms in postmenopausal females, which are common in patients with GSI and DI, often respond to estrogen therapy. No studies demonstrate the efficacy of estrogen in the treatment of DI.

Intravesical pharmacotherapy

Intravesical treatment of DI and hyperreflexia with capsaicin, the main pungent ingredient of hot peppers, recently has been evaluated. Improvement rates of 40-100% have been reported. Observation has ranged from 1-60 months. In the largest of these series, 44% of patients with detrusor hyperreflexia secondary to MS were dry. Positive findings from an ice water test indicating bladder hypersensitivity have been suggested as a method of selecting patients for capsaicin therapy. The proposed mechanism is through desensitization of capsaicin-sensitive unmyelinated afferents. Neuronal damage through osmotic swelling also may occur. One percent intravesical lidocaine is administered 5-15 minutes before capsaicin is administered. Approximately 50-100 mL of 1-2 mmol capsaicin is mixed in 30% ethanol with saline. The solution is left in the bladder for approximately 30 minutes.

Adverse effects can include transient worsening of irritative symptoms or incontinence, perineal pain, a burning sensation, hematuria, and UTI. Administration in the office or hospital, continuous blood pressure monitoring, and the ability to treat acute hypertension are recommended in patients with spinal cord injuries due to the rare possibility of exacerbation of autonomic dysreflexia. A small urethral catheter and balloon occlusion of the vesical neck are used to minimize spillage and leakage. At times, administration of capsaicin is best accomplished under general anesthesia.

Resiniferatoxin, a naturally occurring pungent substance from the Euphorbia resinifera plant, has been shown to have very potent capsaicinlike activity. This substance has been used successfully to treat DI and hyperreflexia. In one small study, some patients who failed capsaicin therapy responded to resiniferatoxin. More research is underway to clarify the role of these therapies in the treatment of urge incontinence disorders, sensory urgency, and interstitial cystitis.

Intravesical oxybutynin has been used in patients who are nonresponsive to the oral form or have severe adverse effects. The medication is self-administered following clean catheterization. This therapy has been shown to be safe and efficacious. Studies have shown that tissue and plasma concentration of the drug are higher after intravesical administration than after oral administration. Despite higher plasma levels, adverse effects appear to be minimal. This finding suggests that a hepatic metabolite may be responsible for many of the adverse effects observed after oral administration.

Functional electrical stimulation

Functional electrical stimulation (FES) has been found useful in therapy for both GSI and DI. In addition to increasing skeletal muscle tone and strength in the pelvic floor, afferent stimulation of the pudendal nerve can result in reflex inhibition of detrusor contractions. The 2 main modes of FES therapy are long-term stimulation and short-term maximal stimulation. Long-term therapy requires the use of an intravaginal or intra-anal probe for several hours a day. Low intensity, subthreshold stimulation is used.

The optimal length of therapy is uncertain, but, most likely, at least several months of therapy are required for reeducation. Improvement rates have ranged from 73-90% in several small series. Reeducation of the bladder and/or nervous system occurs in some individuals, as demonstrated by a carryover effect of 45% for 6 months after discontinuation of therapy. Long-term FES therapy can be useful in patients who have been refractory to other forms of therapy. This treatment also benefits some patients with detrusor hyperreflexia. Patient acceptance of this therapy can be low due to the discomfort of wearing the probe for several hours each day.

Short-term maximal stimulation therapy was developed because it is more practical, and high intensity stimulation may produce a better inhibitory effect. Maximal inhibition of involuntary bladder contractions takes place at stimulation intensity levels that are 2-3 times sensory threshold levels. The closer the proximity of the stimulating device to the selected nerve, the lower the intensity can be and remain effective. In practical terms, maximal tolerance levels usually are approximately 1.5-2 times the sensory perception threshold. Short-term maximal therapy uses high-intensity stimulation for 15-30 minutes once or twice a day. Treatment generally is continued over several weeks. Improvement rates of 52-77% have been documented. Carryover effects of 31-92% have been shown for as long as 1 year after therapy.

Transcutaneous electrical nerve stimulation (TENS) has been tried in patients with DI using several different methods. One method using a positive electrode applied to the area of the anal sphincter and a negative electrode to the posterior tibial nerve has yielded mixed results in 2 studies. TENS of the S2-S3 dermatomes has been tried with some success. An interesting method of alternating stimulation of the hamstring and quadriceps muscle groups recently was reported. In this study, those patients with DI and those patients with detrusor hyperreflexia were included. The subjects underwent 20 minutes of stimulation per day for 14 consecutive days. Clinical improvement was observed in 68%. The mechanism of detrusor inhibition by this method of TENS is unclear but may involve increases in segmental inhibitory tone due to manipulation of peripheral neural input.

Interferential therapy is a type of TENS in which external electrodes are positioned over the pelvis, and the interference produced by the competing electrical fields produces low-level nerve stimulation in the area of interference. A small study showed a 90% improvement rate in 20 patients with DI that was unresponsive to pharmacotherapy. In 18 months of observation, no complications were reported, and no recurrences were observed. Extracorporal magnetic resonance therapy, in addition to being beneficial for stress incontinence, reportedly also has been successful in the treatment of DI. FES via implantable electrode requires a surgical procedure and, thus, is discussed in Surgical therapy.

Acupuncture

Acupuncture is a promising alternative therapy. A 77% improvement rate with 63% of patients dry was reported in a study of weekly therapy sessions for 10-12 weeks.

Behavior modification

Behavioral interventions are based on the assumption that cortical control over a hyperactive micturition reflex can be established or reestablished. Clearly, behavioral therapies can be successful in the highly motivated patient in the short-term. Long-term efficacy is much less certain, and relapse rates, when reported, have been high. In addition to a highly motivated patient, this type of therapy requires a dedicated team to provide support and reinforcement to the patient.

Biofeedback is a type of learning where the patient receives information in the form of visual or auditory stimuli concerning a physiologic function. The patient learns to control this normally unconscious function. In the case of DI, the patient learns awareness of the external striated urethral sphincter that may, in turn, improve the urethrovesical inhibitory reflex. This therapy often is combined with Kegel pelvic floor exercises.

Bladder training can be performed in a number of ways. This author examines the patient's voiding diary and tries to arrive at a reasonable voiding interval that minimizes urge and urge incontinence. The patient uses the chosen interval to void by the clock during waking hours and void as needed at night. The interval is increased by 15 minutes per week until reaching a voiding interval of approximately 3-4 hours. Bladder training can be conducted with or without simultaneous pharmacotherapy. Subjective response rates of 85% and objective response rates of 50% have been achieved with short-term observation.

Intermittent catheterization

This type of management is most appropriate for patients with detrusor hyperreflexia and functional obstruction. Many of these patients have detrusor-sphincter dyssynergia and are at risk for pyelonephritis and upper tract injury. Some patients with urge incontinence and coexisting hypofunctioning detrusors may benefit from self-catheterization. For example, some diabetic patients with bladder neuropathy may have instability requiring bladder-relaxing pharmacotherapy but, at the same time, may have intermittent detrusor hypofunctioning with poor emptying. The addition of bladder-relaxing drugs may worsen the baseline poor detrusor function, resulting in retention and overflow incontinence. In some cases, the solution may be to combine bladder relaxing medical therapy with ISC.

Vaginal prosthetic devices

A disposable vaginal device made of polyurethane, which originally was designed to provide bladder neck support as a treatment for stress incontinence, has been found moderately effective in patients with DI. A combined cure and improvement rate of 56.7% was documented. Few adverse effects were reported, but 21% of the subjects withdrew from the study. Of those who withdrew, 67% cited discomfort or difficulty inserting or retaining the device. The mechanism of action in treating DI is uncertain.

Some theorize that the mechanism is preventing entrance of urine into the proximal urethra and the subsequent triggering of an uninhibited detrusor contraction. The authors offer an alternative hypothesis, ie, local stimulation of the vaginal mucosa leading to detrusor inhibition. More studies of this device need to be conducted. A bladder neck support prosthesis was tested in women with mixed incontinence. A modest reduction in DI was demonstrated, but the discontinuance rate was high. Reasons cited for discontinuation included poor efficacy, the inability to fit the device, or a poor fit.

Medical therapy for nocturnal enuresis

Such basic measures as evening fluid restriction and daytime bladder training can be beneficial. Nasal vasopressin at 10-40 mg decreases nighttime urine production. Imipramine (2 mg/kg/d) has been one of the most common pharmacologic therapies. Oxybutynin and other anticholinergics have been used. Ephedrine recently was found to be moderately beneficial in a recent trial. Some believe that this agent works by increasing urethral alpha-sympathetic tone. Pharmacologic therapies can help, but the underlying disorder often returns after discontinuation. Conditioning therapy with moisture-sensitive alarms are effective. Positive results usually remain even after the device is removed.

Surgical therapy:

Genuine stress incontinence

Procedures for stress incontinence, although varied in terms of approach, share the common goal of stabilizing the bladder neck and proximal urethra. Over 250 procedures, some of which are modifications of older procedures, have been devised. Many others have been disregarded due to poor long-term efficacy, technical difficulties in performance, and/or unacceptable complication rates. Only a few procedures have been the subject of sufficient scientific scrutiny to demonstrate safety and good long-term efficacy.

One major problem in studying these procedures is that the same basic procedure may yield different results in different hands. This may be due to differences in experience and technical expertise, small variations in technique, choice of suture or supportive material, and differences in preoperative patient selection and postoperative care. A few procedures have been shown to yield good results in various clinical settings by a variety of surgeon researchers. These procedures (eg, Burch retropubic urethropexy, MMK procedure, suburethral sling) should be considered the criterion standard against which new procedures should be judged.

Another variable to be considered when examining the literature concerning procedure efficacy is the method and criteria used to define success. Some studies define a successful outcome as a patient who is dry. Others may use degrees of clinical improvement or the patient's estimate of postoperative satisfaction to determine successful outcomes. Investigators have used such techniques as questionnaires and telephone surveys to gather this information. Others have used more objective criteria, such as stress testing or more extensive urodynamic examinations. Many studies have unacceptably large numbers of patients lost to observation. Comparing studies or performing a meta-analysis of data can be difficult or impossible due to the various criteria used. No widely accepted standardized methods or criteria for defining or measuring surgical outcomes in incontinence surgery have been devised to date.

Mixed incontinence

Surgical therapy for GSI is not contraindicated in the setting of mixed (ie, GSI and DI) incontinence. Many authors have recommended medical treatment of the DI portion of the incontinence disorder before proceeding with surgery. With this strategy, some believe that a certain percentage of patients improve to the point that they no longer are seeking surgical therapy. If the DI is treated successfully with medical therapy, some patients find that the GSI component is minor and are content with conservative management, such as pelvic floor exercises.

In a significant minority of patients, surgery for GSI also results in improvement or cure of the DI component. This especially may be true if the stress incontinence symptoms clearly preceded the urge symptoms chronologically. Unfortunately, many patients find no improvement in their urge incontinence after surgery for GSI, and a few experience worsening symptoms. Although the surgery accomplished what it was intended to do (ie, GSI), the procedure may be viewed as a failure by the patient due to the persisting urge incontinence. In the setting of mixed incontinence counseling, painting a realistic picture of the dual nature of patient incontinence disorder, therapeutic options, and possible outcomes especially is important.

Intrinsic sphincter deficiency

Surgical therapy for ISD is centered on the concept of increasing urethral coaptation. If urethral hypermobility coexists with ISD, most experts believe that the chosen procedure also should address this problem. In the clinical situation of a combined disorder of urethral hypermobility and ISD, suburethral sling procedures are considered the therapy of choice. Retropubic urethropexy may be effective in this situation, but some surgeons' failure rates have been higher if ISD is a significant part of the clinical picture.

Some authors have commented that periurethral bulking injections can be used as a secondary procedure if the results of a retropubic urethropexy are not satisfactory. Periurethral injections alone generally have not been recommended with ISD and hypermobility, but efficacy in this situation may be better than once thought. With a patient who is very frail, bulking injections may be the only reasonable option. ISD in the absence of hypermobility can be addressed with a sling procedure, although failure rates may be higher. With a nonfunctioning, immobile drainpipe urethra, an obstructing sling can be performed with the understanding that many, if not most, of these patients must perform ISC.

Alternatively, urethral mobility can be restored with a urethrolysis procedure followed by performance of a sling procedure under the same anesthesia. Because of the safety, low morbidity, and their relative noninvasive nature, periurethral bulking injections are considered the first-line therapy in this clinical situation. Finally, an artificial sphincter may be indicated, especially if other options have failed.

Detrusor instability/hyperreflexia

Surgical therapy should be considered only in severe and refractory cases. Surgical approaches include bladder augmentation procedures; denervation procedures; and, as a last resort, urinary diversion. An exciting, new innovation has been the implantable sacral nerve-stimulating device. In selected patients, this device offers good efficacy with less morbidity than the other surgical options. As mentioned above, procedures for GSI do treat coexisting DI in some instances, but these procedures are not recommended as a primary treatment for urge incontinence. Few individuals have extensive experience with surgical treatment of DI, and most case series are limited by small numbers.

Preoperative details:

Selection of the surgical procedure

The success or failure of incontinence surgery largely depends on selecting the appropriate procedure for the appropriate patient. A correct diagnosis with knowledge of the pathophysiology in each individual case is the cornerstone of planning good surgical therapy. Some cases may be obvious, for example, a large vesicovaginal fistula. In this case, a procedure would be chosen to excise and close the fistula. A procedure designed to treat stress incontinence would not be expected to work because of the specific pathophysiologic findings.

In other cases, the cause of the incontinence may not be as clear. For example, stress incontinence symptoms can be due to urethral hypermobility, intrinsic urethral sphincter deficiency, stress-induced DI, or any combination of the above. A patient history and a physical examination are helpful but should not be relied upon exclusively when planning stress incontinence surgery. Urodynamic studies can help narrow the diagnostic focus further but are not perfect tests for various reasons. A large percentage of surgical failures may be related to an incorrect or incomplete diagnosis. The following are other factors that may influence the type of surgery chosen and the specific approach:

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Preoperative preparation

Appropriate preoperative preparation of the patient may enhance the positive results of a well-performed incontinence procedure. The following are important points to be considered preoperatively:

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A thorough discussion of risks, benefits, anticipated success rates, and potential common complications should be undertaken. A discussion of the possible need for prolonged postoperative bladder drainage or ISC is important. Some surgeons recommend that each patient preoperatively learn and demonstrate proficiency at self-catheterization. A patient with realistic expectations and foreknowledge of possible complications or postoperative difficulties is more likely to express satisfaction with the final result than a patient with unrealistic expectations or one who is surprised by adverse events such as prolonged catheterization.

Intraoperative details:

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Open retropubic procedures

The modified Burch retropubic urethropexy

In 1961, as described in his landmark publication, Burch was attempting an MMK procedure but found that the sutures were pulling out of the periosteum. Burch next chose "the origin of the so-called fascia surrounding the vagina" as an alternative fixation point. He believed that this site was both feasible and anatomically correct. Burch's initial experience was favorable with what essentially was a transabdominal approach to a paravaginal fascial defect repair. Although his initial results were good, Burch feared that the suture bites could pull out of the fibromuscular attachment sites. Burch next employed Cooper ligament as a fixation point; Cooper ligament is a thick fibrous band running along the superior surface of the pubic bone. Burch used number 2 catgut as his suture of choice but thought that steel wire or fascia might be better.

In the original description, 3 sutures were secured on each side of the bladder neck area. Burch noted that the procedure often corrected mild-to-moderate cystoceles, and, indeed at times, he used the procedure for the sole purpose of cystocele repair. Since its original description, the Burch procedure has undergone several important modifications. Many surgeons now use only 2 sutures on each side, 1 set at the level of the mid-to-proximal urethra and 1 set at the level of the bladder neck. Permanent suture often is favored over absorbables.

In 1972, Tanagho described his modification of the Burch procedure. He emphasized avoiding dissection over or close to the urethra to avoid damage to the delicate muscular, vascular, and neural structures intrinsic to this organ. Tanagho described lateral placement of sutures away from the urethra. He also believed that removal of fat from the retropubic space, lateral to the urethra, was an important step aimed at promoting lateral scarification, perhaps improving the long-term efficacy of the procedure. The Burch procedure often is combined with paravaginal defect repair if a significant displacement cystocele coexists with urethral hypermobility and stress incontinence.

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Other operative procedures, such as hysterectomy and additional pelvic repairs, can be performed during the same anesthesia by either the abdominal or the vaginal route. If the cul-de-sac is deep, a procedure to prevent enterocele should be considered. These procedures include the Halban and Moschcowitz culdoplasties and the McCall colposuspension. If the peritoneal cavity is entered, the parietal peritoneum should be closed to prevent bowel and omentum from adhering in the opened retropubic space. Closure of the peritoneum also may decrease the chance of subsequent hernia formation. Hysterectomy does not appear to increase the efficacy of incontinence procedures, including the Burch procedure. Hysterectomy should be considered if indicated for gynecologic reasons. If hysterectomy is performed, secure suspension of the vaginal cuff to the uterosacral ligaments or other appropriate structures should be accomplished.

Temporary bladder drainage can be obtained with a suprapubic or transurethral catheter. Neither method has been proved to be clinically superior, but the incidence of bacterial colonization of the urine is less with the suprapubic method if drainage is required for more than 3-4 days. Voiding trials can begin on the second or third postoperative day. Suppressive antibiotic administration during the period of catheterization is not warranted and, theoretically, may lead to the selection of virulent organisms. Parameters for removal of the catheter vary among surgeons, but each depends on demonstrating an adequate voided volume with a low residual volume. Attention to preoperative uroflowmetry studies can help predict which patients may have postoperative voiding difficulties. Closed suction drainage of the retropubic space is not required routinely but, occasionally, may be needed if persistent oozing is encountered. Any drains should exit for separate stab wounds.

Modified Marshall-Marchetti-Krantz procedure

In 1949, Marshall, Marchetti, and Krantz published a landmark article on a new retropubic procedure for stress incontinence. The original procedure consisted of suturing the urethra, bladder neck, and a portion of the bladder dome to the pubic bone and rectus muscle and fascia. Number 1 chromic catgut suture was used to take large double bites of the anterior wall of the vagina and the surrounding endopelvic connective tissue, along with the lateral aspect of the urethra, excluding the mucosa.

The sutures then were passed through the periosteum and midline fibrocartilage of the pubic bone. Bites also were taken of the bladder wall and rectus muscle and fascia to bring these structures into apposition. The procedure left the UVJ in a very high retropubic position. Of 50 original patients, 82% showed excellent results, and another 7% demonstrated improvement. Since that time, modifications of the procedure may have decreased complications and morbidity rates. The essential steps of the modified Marshall-Marchetti-Krantz (MMK) procedure are as follows:

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The MMK has a well-established record of accomplishment as an efficacious and durable procedure. Some surgeons are critical of the procedure because it tends to overcorrect the hypermobile urethra. Urethral kinking, obstruction, and chronic irritative voiding symptoms may result from over-elevation of the UVJ and from suture placement close to the urethra. Unlike the Burch procedure, the MMK does not correct mild-to-moderate cystocele. Because of the potential for increased morbidity, this procedure is used rarely by this author and only in patients who have failed other procedures.

Ball-Burch procedure

The Ball-Burch procedure is a hybrid retropubic procedure combining conventional Burch sutures with imbricating sutures, gathering bites of endopelvic connective tissue on either side of the urethra. These latter sutures then are tied directly on top of the urethra in the hope that these sutures tighten the urethra, decrease funneling, and add functional length. In the original paper, monofilament delayed absorbable suture was used for the Burch sutures and 2 or 3 chromic sutures (3-0) were used over the urethra. The procedure is designed specifically to treat patients with GSI and low-pressure urethras.

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Paravaginal repair

In 1909, White published a paper describing his technique of cystocele repair with a vaginal approach to paravaginal defects. White's work essentially was ignored until the 1970s when Richardson revived interest in paravaginal defect repair, this time via the suprapubic approach. Since that time, the procedure has gained acceptance as an anatomically correct surgical correction of displacement cystocele. As noted by Burch, reattachment of the connective tissue lateral to the UVJ to the arcus tendineus corrects urethral hypermobility and, oftentimes, GSI. Paravaginal repair soon was touted as an anatomical surgical solution to GSI and cystocele. Advocates pointed out that the procedure did not overcorrect urethral hypermobility; thus, postoperative voiding dysfunction and the need for prolonged catheterization occurred less often.

The paravaginal repair has been demonstrated as a less durable and reliable cure for stress than the Burch retropubic urethropexy. Although the paravaginal repair correctly restores bladder neck anatomy, overcorrection may be required in many cases to compensate for neuromuscular damage to the pelvic floor, which is not repairable surgically. Recently, the paravaginal repair has been combined with Burch or MMK sutures at the bladder neck to treat stress incontinence and coexisting cystocele. This approach is called the paravaginal-plus procedure.

The paravaginal repair can be performed with an open retropubic, laparoscopic, or vaginal approach. The procedure involves the reattachment of the endopelvic connective tissue lateral to the urethra and bladder to the arcus tendinous fascia pelvis from the back of the pubic bone to just anterior to the ischial spine. Since this procedure is used rarely by itself to treat GSI, the technical steps are not discussed in detail.

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Laparoscopic retropubic urethropexies

Laparoscopic procedures for urinary incontinence have been thrust into the surgical limelight in the past decade. Evidence shows that these procedures can be performed successfully. Evidence of short-term efficacy for many procedures recently has emerged. Evidence of long-term efficacy is anticipated eagerly but is not yet present in most cases. Possible advantages of the laparoscopic approach include an improved magnified view of the retropubic space, less blood loss, less postoperative pain, and quicker recovery.

Disadvantages include a steep learning curve with significantly more complications with early cases, the need for laparoscopic suturing skills, and the need for specialized and costly equipment. Uncertain long-term results are another disadvantage. In addition, some authorities have argued that more rapid recovery and a return to normal activities actually may be a disadvantage in disguise by encouraging heavy lifting and activities in the healing phase that may place an otherwise well-performed repair in danger.

In theory, a procedure performed laparoscopically in a fashion that is identical to the open procedure, other than in approach, should yield similar results. Many researchers have taken this theory to heart and are performing Burch procedures through the laparoscope in a way that is true, even in fine detail, to the accepted open modifications of this procedure. The completion and reporting of studies comparing laparoscopic and open approaches to the modified Burch are awaited eagerly.

Other laparoscopic retropubic urethropexies are completely new procedures. Examples are procedures using mesh, staples, and bone screws. Many of these laparoscopic materials and application devices are marketed to private physicians, even though studies validating their efficacy and safety are lacking. These tools are touted for their ease of use, making laparoscopic urethropexy a possibility for even the occasional laparoscopic or incontinence surgeon. The place for these tools is in the hands of researchers and not in widespread use in day-to-day practice.

The laparoscopic approach to GSI and to pelvic floor surgery, in general, holds promise. Unlike extirpative surgery, equivalency to open approaches is difficult to demonstrate. Until research is completed, the laparoscopic approach should be considered experimental. The argument is plausible that equivalent outcomes should be achieved if the procedure performed laparoscopically is otherwise identical to the open procedure. Scientific proof is better than a plausible argument, and no such argument can be put forth for new laparoscopic procedures. These new procedures should not be adopted at this time.

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Needle urethropexies

The development of these procedures stemmed from a desire to develop a simple and minimally invasive procedure for GSI. In 1959, Pereyra described the first such procedure, which used #30 stainless steel wire to support the bladder neck. Since that time, many variations and modifications of the original needle urethropexy have been described.

In general, these procedures involve isolation of the pubourethral ligaments by way of a vaginal entry. Midline anterior, inverted U-shaped, and bilateral periurethral vaginal incisions have been used. Next, digital or instrument perforation of the endopelvic connective tissue is made along the pubic bone at the level of the bladder neck. Access to the retropubic space is obtained in this way. Permanent or absorbable suture then is placed through the pubourethral ligaments and/or paravaginal connective tissue in a helical fashion at the level of the bladder neck. Some procedures also include part or all of the vaginal wall in the suture. A small abdominal incision is made transversely just above the pubic bone and is carried down to the rectus fascia.

Long suture-carrying needles then are passed through the rectus fascia and into the retropubic space using finger guidance through the vagina. The needles are advanced through the previously created defect in the endopelvic connective tissue to emerge through the vaginal incision. The bilateral sutures are threaded through the needles and then pulled back through the retropubic space and rectus fascia to emerge from the small abdominal incision.

Traction on the sutures produces elevation of the UVJ and closure of the bladder neck and proximal urethra. Using a free needle, a bite is taken with 1 strand from each side, through the rectus fascia. The 2 sutures are tied independently over the rectus fascia. The 2 sutures also can be tied to each other over the midline for extra security. The proper tension on the sutures before tying has been determined by various methods, including correction of the Q-tip angle and urethroscopic visualization of proximal urethral closure. No one method has proved to be superior. The following are a few common variations of the needle urethropexy procedure:

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The needle urethropexy is a relatively quick and simple procedure for stress incontinence. The short-term results generally have been good, but long-term efficacy, in most studies, has been less favorable. Failure of these procedures often is due to suture pull-out. Many of these procedures rely on single sutures on either side of the bladder neck. Formation of significant retropubic scarring, which is thought to augment the supportive effect of sutures in open retropubic procedures, probably is minimal with needle urethropexies.

These procedures are used rarely at the institution of this author because of their unacceptably high long-term failure rate. A possible role for these procedures is in the patient who is elderly and debilitated with a short life expectancy or in an inactive patient who is expected to place minimal stress on the repair. Some newer procedures have been developed that use bone anchors rather than rectus fascia for the suprapubic attachment. Because the site of suture pull-out more commonly is from the vaginal side, whether bone anchors improve long-term efficacy is uncertain. The possibility of osteitis pubis and osteomyelitis also is a significant concern.

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Suburethral sling procedures

Sling procedures of various types are among the oldest and most successful procedures for incontinence. These procedures have been used for approximately 100 years. In the early 1900s, Goebel and Stockell independently described the use of the pyramidalis muscle to form a suburethral sling. In 1942, Aldridge described his classic rectus fascial sling procedure. He developed strips of rectus fascia that were left attached in the midline. These strips of fascia were tunneled through the retropubic space and delivered to the suburethral area that previously had been exposed via a vaginal incision. The strips were sutured in the midline under the bladder neck. Modern sling procedures are based on this procedure. Numerous modifications and simplifications of sling procedures have been described, including patch slings with suture arms, inferior pubic ramus bone attachments, vaginal wall slings, overlapping suburethral fascial flaps, and tension-free slings.

Various materials have been used, ranging from a host of permanent synthetic materials, cadaveric donor fascia, and endogenous rectus fascia to fascia lata and vaginal wall materials. These modifications are a testament to the ingenuity and creativity of incontinence surgeons. Each modification is an attempt to refine sling procedures by improving efficacy, lowering morbidity and complications, simplifying the procedure, and decreasing invasiveness. However, a recent review article pointed out that no randomized trials comparing sling procedures or methods have been conducted. As a result, no solid data exist to help decide which procedure is best.

Surgeons in the last decade have witnessed a renewed interest in sling procedures. This interest can be linked to the realization that, in most cases, a sling does not need to be obstructive to be successful. The most feared complications of sling procedures, including permanent obstruction, urethral erosion, and urethral transection, are related partly to sling tension. Tying slings with little or no tension likely decreases the incidence of these complications. As a result, procedures that were once reserved for only the most severe, recurrent, and refractory cases are becoming accepted as mainstream and even primary procedures. Most recognize that GSI due to hypermobility often carries with it some degree of ISD. Sling procedures especially are attractive in light of this fact because the procedure ameliorates both problems.

The diagnosis of ISD is difficult, and the best test(s) and diagnostic criteria are controversial. Proponents of primary sling procedures argue that if a sling procedure is chosen, the need to diagnose ISD in the setting of stress incontinence and the hypermobile urethra is obviated. Opponents of primary sling procedures state that these procedures may be technically more difficult than other incontinence procedures, and lower complication rates due to less sling tension, although hoped for, have not yet been confirmed.

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Tension-free vaginal tape

A promising and less invasive variation of the combined abdominovaginal approach to the sling procedure has been described recently in several studies. This technique uses a thin strip of Prolene mesh with barbed edges to serve as artificial pubourethral ligaments. Both ends of the tape are attached to sharp curved trocars, and the tape is encased in plastic. After minimal suburethral and periurethral dissection is performed transvaginally, the trocars are tunneled in the periurethral area, under the pubic ramus and through the space of Retzius. The trocars are delivered through 2 small transverse incisions just above the pubic bone.

The central body of the mesh should be located at the mid urethra, although some experts believe that the final location usually is closer to the proximal urethra and UVJ. When the sling ends are visible through the abdominal incisions, they are grasped with clamps, and the trocars are released. The plastic encasement then can be released in the middle, and the 2 pieces can be pulled up and out through the abdominal incisions. The plastic is intended to minimize contamination of the mesh with vaginal bacteria and to aid in sliding the tape into place. Cystoscopic inspection of the urethra and bladder should be performed, looking for injury and foreign material.

To facilitate adjustment of sling tension, performing the procedure under local anesthesia and sedation is recommended. The awake patient is asked to cough repetitively, while tension on the sling arms is increased until stress-induced leakage is eliminated. At this point, the sling arms are trimmed flush with the skin and released, and the arms retract below the skin level immediately. The sling is not sutured in place. Some believe that friction of the barbed edges of the sling material against the trocar-perforated edges of the endopelvic connective tissue and rectus fascia provides points of fixation and stability. Eventually, scarification may provide additional support. Excellent short-term success rates, low rates of voiding dysfunction, and low rates of sling rejection have been demonstrated. In some series, high rates of bladder perforation at the start of the learning curve have been evident, but, if recognized and corrected, this complication should rarely increase long-term morbidity.

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All-vaginal methods

Two all-vaginal methods of creating a suburethral sling have been described.

Patch sling with suture arms

The first involves placement of a patch sling of synthetic material with suture arms. The suture arms are secured via bone anchors to the vaginally exposed underside of the pubic ramus. In addition to the all-vaginal approach, the biggest advantage of this procedure is that using the inferior side of the pubic ramus as an anchoring site makes it very difficult to tie the sling under too much tension. A serious theoretical concern is the potential for osteomyelitis, especially concerning transvaginal placement of bone anchors. At present, this author is not aware of any reported cases of bone infection with this procedure.

Paraurethral fascial sling urethropexy

The second all-vaginal approach is a procedure used extensively at this author's institution. The paraurethral fascial sling urethropexy (PFSU) procedure is described in detail by the procedure's originator, Marvin H. Terry Grody, MD, in his textbook Benign Postreproductive Gynecologic Surgery. The interested reader is directed to this text to supplement the description presented below.

The PFSU procedure begins with a midline vaginal incision as is made in a standard anterior colporrhaphy. The incision is carried to within 1.5-2 cm of the urethral meatus using the relatively avascular space between the vaginal wall and the pubovesicocervical connective tissue. The endopelvic connective tissue then is dissected off the vaginal wall flaps using sharp and blunt dissection as needed. This dissection is carried far laterally until the natural insertion of this tissue is reached at the ATFP or white line. The white line extends from the inferior pubic ramus to just anterior to the ischial spine. This dissection must be complete.

At this point, the bladder neck and proximal urethra are located with the aid of a transurethral Foley catheter. The endopelvic connective tissue then is grasped just lateral to the midline on either side with a succession of 3 Allis clamps. The clamps are at the level of the proximal urethra, UVJ, and bladder neck, respectively. The clamps are placed on gentle traction in a direction out toward the surgeon, and sharp dissection is initiated on the medial aspect of the clamped tissue. The dissection must be carried out slowly and meticulously to avoid entry into the urethra or bladder. Bilateral flaps of approximately 2-2.5 cm in depth are created.

Transillumination of the tissue flaps with a small light source helps the surgeon determine that no bladder wall or urethral tissue remains attached. This tissue is strong but can be torn, especially in the direction of the connective tissue fibers. To avoid tearing, the clamps should be handled gently and should not be twisted.

Whether this tissue, once dissected, retains its own neurovascular supply is controversial. Pelvic floor denervation injury and partial recovery have been shown to occur with extensive vaginal dissection, but the clinical consequences of this injury are uncertain. In the experience of surgeons performing the PFSU procedure, no clinical evidence of tissue necrosis or urethral sphincter denervation has been apparent.

Once the sling flaps are created, they are sutured together in an overlapping fashion using permanent 0 or 2.0 polytetrafluorethylene suture. The resulting double-thickness tissue provides an excellent hammock or backboard for the urethra and bladder neck. Some believe that the overlapping of these flaps may decrease urethral funneling and increase the anatomic urethral length.

After suturing the flaps, reestablishment of a firm connection of the lateral aspect of this connective tissue to the fascial white line is necessary. Next, a vaginal-paravaginal repair at the level of the bladder neck is performed. Usually, 2 sutures per side are required, approximately 1-1.5 cm apart at the level of the proximal urethra and bladder neck. These sutures are placed far laterally in the same connective tissue that makes up the previously described flaps. Bites then are taken at the corresponding location on the white line.

The proximal urethral stitch is placed through the white line just under the pubic bone and the second stitch, approximately 1.5 cm below the first stitch. Some surgeons take a third tissue bite with each stitch through the underside of the vaginal mucosa at the anatomically correct level. This bite pulls the vaginal mucosa up into the lateral sulcus once the suture is tied. This 3-point suturing technique is optional and probably does not add to the efficacy of the procedure.

When the suturing is complete and the strands are tied, the result should be a gentle elevation of the UVJ. If the endopelvic fascial bite is taken too medially, over elevation and anatomic distortion results. Such aggressive elevation also may kink the ureters. Therefore, this author performs cystoscopy in all patients to ensure bladder and urethral integrity and to demonstrate ureteral patency.

After the PFSU is complete, the paravaginal repair can be continued, if needed, with interrupted sutures to approximate the pubovesicocervical connective tissue for the full length of the white line. Midline plication of this tissue also can be performed if such a defect or weakness exists. Each case is individualized to repair each defect as encountered.

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Vaginal procedures

In addition to the 2 all-vaginal approaches to the suburethral sling procedure described above, simple suburethral plication of the endopelvic connective tissue has been used as an incontinence procedure in the past. Kelly described this approach, which was the first widely used procedure for stress incontinence. This procedure usually is performed in conjunction with an anterior colporrhaphy for cystocele and is referred to as the Kelly or Kelly-Kennedy plication. The procedure is simple to perform, but the long-term durability of the procedure has been poor in several different studies.

Kelly plication may still have a role in patients with only minor degrees of stress incontinence or in patients with urethral hypermobility and severe anterior compartment prolapse in whom incontinence cannot be demonstrated with pessary placement or prolapse reduction and stress testing. Further research is required to define the role of this procedure in the surgical incontinence armamentarium. Similar procedures have been described by Beck and Nichols, which may provide for better long-term efficacy. The Beck procedure involves taking a suture bite of the periosteum of the inferior pubic ramus on either side of the urethra before tying. Nichols plicates the suburethral tissue in a more aggressive overlapping fashion. Validating studies of the long-term effectiveness of these procedures currently are not available.

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Periurethral injection procedures

Periurethral injections are the procedures of choice for patients with ISD and immobility of the bladder neck. Emerging evidence points to efficacy in patients with ISD and bladder neck hypermobility. Various bulking agents have been used, including autologous fat, Teflon (Dupont Co, Wilmington, Del), and silicone microspheres. In 1993, collagen was approved for use as a periurethral bulking agent by the FDA. Since that time, collagen quickly became the material of choice in the United States. In addition to the above criteria, good candidates for periurethral injection should have no evidence of UTI, no significant PVR volume, and a normal bladder capacity.

The periurethral method is described first. Although considered technically more difficult, this method has the advantage of requiring little specialized equipment. Generally, prophylactic antibiotics are administered. The essential steps of periurethral collagen injection are as follows:

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Fistula repair

A detailed description of the operative management of urinary tract fistulas is beyond the scope of this article, but several important points are highlighted. A clear understanding of the anatomy and the structures involved in the fistula must be obtained before surgical closure. Involvement of the ureters, bladder neck, trigone, and urethra complicates surgery considerably. On occasion, the uterus and/or cervix can be involved on the genital side of the fistula. Cystoscopy, retrograde urography and IV pyelography are useful in defining the anatomy and in determining which structures are involved. The timing of surgical repair can be controversial. Fistula repair is best accomplished at a time when infection, inflammation, edema, and granulation tissue are absent. A 3- to 6-month waiting period, from the time of injury to the time of repair, has been recommended for simple vesicovaginal fistulas. Serial cystoscopic examinations have been recommended to determine the earliest possible date of closure.

Two common methods are used to repair simple, small (<2-3 cm), vesicovaginal fistulas. The classic method involves excision of the fistula tract with mobilization and closure of the various anatomic layers of the bladder and vaginal wall. The second method, the Latzko partial colpocleisis, involves partial ablation of the fistula by denudation of the vaginal mucosa around the fistula and interposition of layers of the vaginal wall tissue over the fistula.

Successful fistula repair requires adequate dissection and mobilization of tissues, meticulous hemostasis, and reapproximation under no tension. Blood supply to the healing tissues is important. If the tissue is thin, avascular, or irradiated, fresh blood supply must be brought surgically into the field. Omental or bulbocavernosus fat pad flaps are time-honored methods of augmenting vascularity. Surgical approaches to fistula repair must be individualized. Vaginal, abdominal, and combined abdominovaginal approaches each may be appropriate in certain situations as defined by the relevant surgical anatomy. Laparoscopic approaches recently have been described.

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Urethral diverticulum repair

Urethral diverticula occasionally can cause urinary incontinence. Classic symptoms include postvoid dribbling of urine, dyspareunia, and recurrent UTIs. The surgical repair of these lesions shares many principles of fistula repair. Adequate mobilization of tissue and meticulous hemostasis are important to avoid complications such as urethrovaginal fistula. Diverticula distal to the urethral sphincter usually can be treated with simple marsupialization (ie, Spence procedure). Diverticula in the mid-to-proximal urethra must be treated with more extensive surgical excision, as outlined below.

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With both repair techniques, cure rates of approximately 90% can be expected if meticulous surgical principles are followed. Stress incontinence procedures, such as the suburethral sling, have been combined successfully with surgical diverticulum repair.

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Cystoplasty

Augmentation cystoplasty has been used in cases of refractory DI. The basic technique involves bisecting the bladder with the suturing of an opened pedicled section of bowel into the defect. Most commonly, ileum is used, although large bowel and stomach also have been used. Cure rates for DI approach 90% with this technique, but approximately 25% of patients have voiding difficulties, including incomplete emptying. Many of these cases require ISC. Mucus production and stone formation can be problematic for some patients. Malignant transformation of the bowel epithelium has been reported and is a major concern. Recently, detrusor myomectomy has been used to create an intentional bladder diverticulum. Most of the experience with these autoaugmentation procedures has been in neuropathic patients with decreased compliance and/or contracted capacity. Further study is required to determine the role of these procedures in refractory DI.

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Denervation procedures

Denervation procedures for refractory DI have been performed for many years. Such procedures include selective sacral neurectomy, the Ingelman-Sundberg procedure, bladder transection, subtrigonal phenol injection, and bladder distention. Selective sacral neurectomy is a procedure performed by neurosurgeons. Electrical stimulation is used to identify which nerve roots increase intravesical pressure. A limited sacral laminectomy is performed, and the selected sacral nerve roots are transected bilaterally. Limited experience with this procedure exists, although reported results have been favorable.

The Ingelman-Sundberg denervation procedure is performed via a vaginal subtrigonal dissection. First, an inferior pelvic nerve block is performed in an attempt to predict a successful outcome. If the injection decreases symptoms, proceeding with surgery is reasonable. A midline vaginal incision or inverted U-shaped incision is made to gain access to the subtrigonal area. Soft tissue beneath the trigone is dissected and excised between 2 clamps. Care must be taken to avoid dissection in the suburethral area to avoid damage to the urethral sphincter. In addition, the lateral attachments of the endopelvic connective tissue at the bladder neck must be preserved to avoid new-onset stress incontinence.

Occasionally, patients may require prolonged catheterization or ISC after this procedure. In addition, injury to the ureters is possible, so confirmation of ureteral functioning before concluding the procedure is important. Some surgeons catheterize the ureters to aid in their recognition intraoperatively. A recent study of a modified version of the Ingelman-Sundberg procedure showed a subjective cure rate of 64% with a mean observation of 14.8 months.

In 1967, Turner Warwick first reported on bladder transection. A full thickness incision is made through the bladder wall from 1-2 cm lateral to 1 ureteral orifice across the dome and to the opposite ureteral orifice. The bladder is sutured shut immediately using a single layer closure. Procedures involving multiple detrusor myomectomies and circumferential dissection of the bladder (ie, cystolysis) also have been described. These procedures are not in widespread use, and their role in the management of refractory DI is uncertain. Subtrigonal 6% phenol injections have been used to achieve local neurolysis.

Short-term successes have been reported, but long-term efficacy has not been good. Morbidity can be high, and serious complications, such as fistula formation and ureteral injury, have been reported.

Many authorities no longer recommend the procedure. Some researchers believe that this procedure is effective in cases of detrusor hyperreflexia secondary to MS. Bladder distension causes degeneration of unmyelinated nerve fibers. The result can be decreased sensory and motor neurologic function. Success rates can be as high as 60-70% initially but fall off to less than 10% by 6 months.

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Implantable sacral neuromodulation devices

Implantable sacral nerve stimulating devices have been used successfully to treat refractory urge incontinence, urgency-frequency syndrome, and voiding dysfunction. In cases of urge incontinence, the rationale behind this therapy is to restore the spinal reflexes responsible for the normal bladder function of urinary storage. The mechanism of action of neuromodulation is understood poorly. The activation of spinal inhibitory pathways is a plausible but probably incomplete explanation.

The commercially produced stimulating device is called the InterStim (Medtronics Inc, Minneapolis, Minn). Appropriate candidates include patients who have failed or cannot tolerate other treatments for urge incontinence and who have demonstrated improvement of symptoms during test stimulation. In addition, patients should have the ability to operate the device and should have no evidence of outlet obstruction. A trial with a test stimulator provided by Medtronics should be conducted. By conducting the test stimulation for 3-7 days, the clinician can determine the integrity of the sacral nerves and the effect of stimulation on the patient's symptoms. In addition, the patient can determine if the resulting sensation is tolerable and acceptable.

The details of surgically implanting the permanent device are not described; however, unilateral implantation is typical. Usually, the third sacral segment is selected. The neurostimulator is implanted subcutaneously in the abdomen. The lead is placed adjacent to the appropriate sacral nerve root in the foramina through an incision in the back overlying the sacrum. The lead is tunneled around the side subcutaneously to connect with the neurostimulator. A handheld wireless patient programmer is used to adjust levels of stimulation as prescribed by the physician. Stimulation parameters can be adjusted noninvasively as needed. The programmer also can be used to turn the device on and off.

In a study of patients with refractory urge incontinence, 47% were dry 6 months after implantation and another 29% experienced a greater than 50% reduction in incontinence episodes. Complications included generator site pain, implant site pain, and lead migration. Approximately one third of the patients required surgical revision to treat or resolve a complication. Approximately 4% required permanent removal of the device because of complications. The infection rate was 2.5%. No permanent nerve injuries were reported. In another small study, 50% of the patients were dry with another 25% greatly improved. Longer-term studies of the efficacy, safety, and patient acceptability of this device are needed.

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Artificial urethral sphincter

In 1972, the artificial urethral sphincter (AUS) was introduced for the treatment of severe ISD. Since that time, the construction and design of the device has improved. The current model (American Medical Systems 800) is made of silicone and consists of a pressure-balloon reservoir, a control pump with deactivation button, an inflatable cuff, and connective tubing. The balloon reservoir is designed to accommodate a volume of fluid that can provide for a range of preset pressures. Required pressures can vary depending on urethral size, location of the cuff, and specific clinical circumstances. Activation of the device is achieved with sustained compression of the pump. In the activated mode, the cuff is depressurized by squeezing the pump and by forcing fluid through a unidirectional valve and into the reservoir balloon. The cuff stays deflated for 3-5 minutes to allow voiding and then automatically reinflates. The deactivation button can be pushed to prevent reinflation. This places the device in deactivatedmode.

The AUS can be implanted surgically via the abdominal or vaginal routes. The abdominal route is the only available approach in the male patient. This approach has the advantage of less bacterial contamination, but the dissection around the urethra is difficult, and injury to the urethra and bladder neck may be more common. The site of placement in the male patient is the bulbous urethra, and, in the female patient, it is the bladder neck and proximal urethra. Strict adherence to sterile technique is of utmost importance. The use of surgical hoods and the limiting of traffic in the operating room sometimes are recommended.

The abdominal approach is performed in the dorsal lithotomy position. In the female patient, the vagina is prepped, and some surgeons pack it with iodine-soaked gauze. A 16F transurethral Foley catheter with a 30 mL balloon is placed. The retropubic space is approached most commonly through a transverse skin incision. Muscle-splitting incisions may increase surgical exposure. After the retropubic space is entered, the urethra and bladder neck are located.

Some surgeons place a Babcock clamp around the urethra to provide elevation to facilitate suburethral dissection. The endopelvic connective tissue on either side of the urethra and/or bladder neck is incised. A right angle clamp is used to create a tunnel under the endopelvic connective tissue and urethra. Gentle traction on the Babcock clamp can aid in this dissection. In the female patient, some surgeons use a finger inside the vagina to guide the dissection. Others prefer the vagina to be packed (as described). Caution must be used to avoid dissection in the area of the trigone and ureteral orifices.

Once a suburethral tunnel of approximately 2 cm in width is created, a cuff sizer is passed around the urethra or bladder neck to determine the size of the cuff required. The cuff is tunneled through and snapped into place. The tubing should exit the cuff laterally. The tubing is placed through the layers of the anterior abdominal wall, including the belly of the rectus muscle on one side. The reservoir balloon is placed in the prevesical space on the same side.

The tubing from the balloon to the pump pierces the layers of the abdominal wall (as described) until it reaches a subcutaneous location. The tubing and pump are tunneled subcutaneously into the labia majus or scrotum. Hegar dilators can be used to help create space for the pump. The tubing from the pump to the cuff runs subcutaneously and also pierces the abdominal wall and enters the retropubic space where it connects to the cuff. Once placed, the device is cycled and then deactivated. The device remains deactivated for 6-8 weeks, while healing and encapsulation occur.

The vaginal approach to artificial sphincter placement begins with an inverted horseshoe-shaped flap incision with the apex midway between the urethral meatus and the bladder neck. The vaginal mucosa is dissected completely away from the underlying connective tissue. The retropubic space is entered via sharp or blunt dissection, with the dissecting instrument pointed towards the ipsilateral shoulder. With blunt dissection, the proximal urethra and bladder neck are mobilized off the pubic bone. The previously placed guidance Foley catheter is removed so that the urethra can be sized accurately. The measuring tape is passed around the urethra. The appropriately sized cuff is passed around the urethra and closed shut. The cuff should be oriented so that the tubing is exiting laterally.

Cystoscopy is now performed to check for bladder integrity and the location of the ureteral orifices in relation to the cuff. A transverse suprapubic abdominal incision is made down to the rectus fascia. A small midline incision is made in the fascia. The water balloon pressure reservoir is passed through the incision and into the prevesical space. The attached tubing is brought out through a small puncture wound in the rectus muscle and fascia.

The cuff tubing then is transferred into the retropubic space on the same side through the vaginal incision. The cuff tubing then is brought out through the rectus muscle and fascia near to the area that the balloon tubing pierces these structures. As with the abdominal approach, Hegar dilators are used to create a pocket in the ipsilateral labia majus. This pocket houses the pump. The tube, pump, and reservoir connections are made. The device is tested and deactivated, and the incisions are closed. Postoperative care and device activation are the same as with the abdominal approach.

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Urinary diversion

Although they are valuable reconstructive procedures in cases of neoplastic and severe inflammatory diseases of the bladder, urinary diversion procedures are the last resort in incontinence disorders. Instances where these procedures might be used include failed closure of bladder exstrophy and severe, debilitating, refractory urge incontinence. Continent diversions, such as catheterizable pouches and orthotopic bladder substitutions, almost always are possible. The details of these complex procedures are beyond the scope of this article.

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Complex reconstructive procedures

Bladder exstrophy is a rare congenital anomaly that requires extensive and complex reconstructive procedures. The reported incidence of this disorder is 1 case per 50,000 population to 3.3 cases per 100,000 population. The male-to-female ratio is 2-3:1. In classic exstrophy, the bladder is everted with a firm, hyperemic, and polypoid mucosa. Chronic inflammation may be followed by metaplasia and malignant change unless early repair occurs. Fibrosis often occurs within the detrusor muscle, resulting in bladder dysfunction and possible upper tract damage after a successful closure. Often, the urethra is short, and the pelvic floor is deficient due to attenuated attachments and pubic diastasis.

Surgical treatment consists of staged reconstruction. The goals of surgical management include urinary continence, preservation of renal function, sexual functionality, and preservation of fertility. Epispadias sometimes accompanies exstrophy or may be found only rarely as an isolated disorder. For defects distal to the urethral sphincter, repair is easy and usually results in continence. Defects that are more proximal and associated with exstrophy are more complicated to manage. In some cases, the urethra may be difficult to locate. Staged repair is described briefly as follows:

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Postoperative details: Postoperative care is similar for patients undergoing each of the incontinence procedures discussed above, with the exception of periurethral injections, sacral neuromodulator implants, and complex reconstructive procedures. Bladder drainage is an essential aspect of postoperative care. The details have been discussed. Drainage allows the bladder to rest while postoperative edema and inflammation resolve. Most patients are able to void spontaneously in 3-7 days. A few patients require drainage for several weeks. Catheterization rarely is needed longer than 3-4 weeks.

Consider clean ISC at this point. Urethrolysis may be indicated if the patient is unable to void spontaneously after a long period and is unable or unwilling to perform self-catheterization. Straining and large sudden increases in intra-abdominal pressure should be avoided. Take measures to control chronic coughs and to avoid or treat constipation. The patient should avoid lifting anything heavier than 10 pounds for 12 weeks. The long-term success of the repair may depend partly on the patient's lifestyle and activities. Smoking and activities that repetitively stress the pelvic floor may result in long-term failure of the procedure.

Nutrition in the postoperative healing phase also may affect long-term outcomes. Vitamin C especially may be important in collagen formation, and supplementation should be provided liberally. Estrogen may have a positive effect on the healing tissues and should be replaced as indicated. De novo DI can complicate a certain number of procedures, even when performed by the best physicians, and can result in a high degree of patient dissatisfaction if not treated. Most cases respond to conventional treatment, and many cases may be self-limited.

Follow-up care: Follow-up care of patients after incontinence surgery consists of surveillance for persistent or recurrent incontinence, voiding dysfunction, and signs or symptoms of pelvic organ prolapse. If postoperative incontinence or voiding dysfunction is identified, complex urodynamic testing is indicated. Patients with foreign bodies, such as synthetic slings and artificial sphincters, should be followed closely for infections, erosion, and rejection. Patients with artificial sphincters should receive follow-up care because of the high incidence of device malfunction. Surgeons should consider referral to a urogynecologic specialist if they do not have experience with complex incontinence issues.

In instances of loss of compliance and increased bladder pressures, monitoring for upper tract damage needs to be considered. Correction of this situation with bladder augmentation or other procedures usually constitutes the best management. In cases of urinary diversion, late complications are not uncommon. Metabolic disturbances, stone formation, mucous obstruction, secondary malignancy, ureteral reflux, ureteral stenosis, and loss of reservoir compliance are some of the more worrisome long-term problems encountered.

COMPLICATIONS ¡@

Surgical and postsurgical complications are an unfortunate reality in incontinence surgery. Even for patients treated by the most experienced and skilled physicians, a certain small number of complications occurs. Recovery can be difficult, and long-term or permanent disability can occur. These potential problems must be taken into account when counseling patients and weighed against the disability caused by the incontinence itself. The patients should be prepared for the possibility of complications, procedure failure, and prolonged catheterization or ISC.

Avoiding complications

The following measures can be taken by the surgeon to minimize the number and severity of these complications:

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Complications such as intraoperative hemorrhage or visceral injury can be immediate. Other complications, including erosion of sling material or wound infection, can be delayed. Minor and transient injury or severe, permanent, and debilitating problems may exist. Patient prognosis for hemorrhage, urinary tract, and visceral injuries is better if diagnosed and repaired intraoperatively rather than in the postoperative period.

Routine intraoperative cystoscopy detects most of these injuries. Ureteral patency can be demonstrated by observation of the free flow of blue-stained urine from each ureteral orifice following IV administration of indigo carmine dye (see Image 1). One recent review found that 90% of unsuspected bladder injuries and 85% of unsuspected ureteral injuries were detected with routine intraoperative cystoscopy and were managed successfully under the same anesthesia. Sling procedures traditionally have resulted in the highest rates of long-term voiding problems.

Past studies have demonstrated that approximately 8% of patients require long-term or permanent ISC. The incidence of voiding dysfunction after various procedures varies widely and depends partly on the type of procedure but also on technique¡Xmost importantly, how tightly the suspension sutures or slings are tied or placed. Increasingly, many recognize that both slings and colposuspension sutures do not need to be tight to be effective. Voiding complications may be on the decline due to this realization. In addition to ISC, postsurgical voiding problems have been managed with varying results with cholinergic agents, alpha-blockers, and intravesical prostaglandin therapy.

Hemorrhage

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Urinary tract and visceral injury

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Urinary tract infection

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Wound infection

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Osteitis pubis

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Osteomyelitis

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Urogenital fistula

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Nerve injuries

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Voiding dysfunction

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Detrusor instability

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Genital prolapse

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Other complications

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OUTCOME AND PROGNOSIS ¡@

Measuring and comparing outcomes following the surgical treatment of incontinence arguably is the most difficult and challenging aspect of incontinence-related research for many reasons. Lack of standardization of outcome criteria and study methodology is one reason for the difficulty. Outcomes can be measured subjectively or objectively. When performed simultaneously, objective measurements of success tend to be somewhat lower than subjective rates. Objective criteria are more easily quantifiable and comparable, but, in many cases, the urodynamic tests used to obtain objective data have not been standardized or sufficiently studied. Subjective patient-oriented criteria may be more clinically relevant but may be more subject to bias. Long-term observation of patients can be difficult, and missing data can be a problem.

Measuring and comparing outcomes also are difficult because of varying definitions of successful outcomes. Some studies may define success as a patient who is dry. Other studies may use varying definitions relating to a decreasing number or severity of incontinence episodes, decreased pad use, or pad weight.

Length of observation also is an issue. The efficacy of incontinence procedures is believed by most to decrease with time. Many procedures show a steep fall in cure rates at 1-5 years. After 5 years, the rates may stabilize, but far fewer data exist on the efficacy of incontinence procedures in the long term. With the increasing awareness of incontinence disorders and the increasing lifespan, efficacy at 10, 20, and even 30 years becomes relevant.

Measuring and comparing outcomes also is difficult because of the variability of patient populations across studies. Groups with prior operative failures have higher failure rates with subsequent operations. Other variables, such as age, obesity, sphincter involvement, coexistent DI, ethnicity, medical comorbidities, and postoperative lifestyle issues, may affect outcome and are difficult to control. Another problem is variations in technique across studies. Small variations in surgical technique have an unknown but potentially significant effect on outcomes. Variations in surgeon experience may affect the degree to which findings can be generalized. Other considerations include cost, quality of life issues, and complication-related morbidity, which are not measured universally and consistently in studies. Although difficult to measure, these aspects of outcome analysis are important.

In 1992, the stress, emptying, anatomy, protection, and inhibition (SEAPI) staging system was developed to address some of the inconsistencies in outcome analysis. The system has a subjective arm, based on patient symptoms and an objective arm, based on physical examination and urodynamic studies. The system can be used preoperatively to grade incontinence and postoperatively to describe outcomes. Each patient has 5 components graded subjectively and objectively. The 5 components form the acronym SEAPI, as follows:

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Each component is graded on a scale of 0 (best) to 3 (worst). The interested reader is directed to the original publication (see Bibliography) for more details. Perhaps in the future, tools such as this will be used to standardize outcome analysis.

Surgical outcomes for GSI

Many studies of the results of individual operative procedures for incontinence have been published. Most are flawed because of flawed design, inadequate power, and short observation. Relatively few studies comparing procedures prospectively have been reported. When considering the body of literature as a whole, the following general statements can be made:

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Retropubic urethropexies

Retropubic colposuspensions (ie, Burch, MMK) generally have been shown to be more effective than anterior colporrhaphy with Kelly plication or needle urethropexy. One notable exception is a series by Riggs and Riggs (1997), in which cure rates for modified Pereyra procedures and MMK procedures were approximately the same (87.8% vs 84.8%). Observation ranged from 6 months to 27 years. How clinical cure was determined is unclear in the report.

A well-known randomized controlled study compared GSI cure rates for the Burch retropubic urethropexy, the modified Pereyra needle urethropexy and anterior repair, and the Kelly plication. Objective outcome parameters were used. The results at 1 year of observation were cure rates of 87%, 70%, and 69%, respectively. At 5 years, cure rates had fallen to 82%, 37%, and 43%. This landmark prospective study suggests that the Burch procedure is the most durable of the 3 procedures.

An institutional retrospective review of 544 incontinence procedures was conducted. Five years after the operation, patients were contacted to arrange for assessment. The authors were successful in evaluating 60% of the original group. Objective continence rates of 61%, 49%, and 79% were reported for modified Kelly plication, anterior colporrhaphy plus needle suspension, and Burch colposuspension, respectively. The choice of procedure was at the discretion of the surgeon. Of note, in a subgroup of patients with grade 1 or mild incontinence, modified Kelly plication carried an 82% 5-year cure rate. With grade 2 and 3 incontinence, cure rates fell to 55% and 0%, respectively. The authors believe that, although the Burch procedure had overall superior results, anterior colporrhaphy still may have a place, especially in a patient with mild incontinence who is frail.

In a study from Switzerland, the cases of patients treated with a retropubic urethropexy were followed for 5 years. Rigid criteria were used to define success, including patient reports of being completely dry and free of symptoms and negative findings on a cough stress test with 400 mL in the bladder. Researchers reported an 82% cure rate. One group reported long-term follow-up of 10-12 years in 109 patients. The success rate reached a plateau at approximately 69%. As a repeat procedure, success rates of 69% and 80% were reported in 2 studies. The percentage of patients with ISD in these studies is unknown. The first of these studies also found that in 63% of the patients expressing dissatisfaction with the surgery, the major complaint was sensory-urgency. Finally, in a retrospective examination of retropubic urethropexy failures, a group reported pelvic floor neuropathy to be a significant risk factor for failure.

Laparoscopic retropubic urethropexy

Research in incontinence surgery often has revolved around the evaluation of laparoscopic approaches. Studies of the laparoscopic Burch urethropexy have demonstrated cure rates ranging from 6-100% with follow-up at 3-36 months. Complication rates from 0-25% have been cited, with surgeon inexperience being the major contributing factor. Procedures using mesh/staple or suture/staple combinations have resulted in cure rates in the range of 70-100%. Observation has been from 6-25 months, and complication rates have been from 5-17%. The laparoscopic paravaginal plus procedure, which combines the Burch procedure and paravaginal repair, has yielded excellent results in the hands of experienced surgeons. A cure rate of 93% for stress incontinence and cystocele recently was reported using this approach. Trials comparing open and laparoscopic Burch procedures have yielded mixed results. Several trials demonstrate equal efficacy.

Two studies, in particular, stand out because they report higher failure rates in the laparoscopic group. One study shows a 96% cure rate in the open group and an 80% cure rate in the laparoscopic group. This study has been criticized due to the use of only 1 suture on each side of the bladder neck in the laparoscopic group. The other study reports a cure rate of 93% in the open group and 60% in the laparoscopic group after 36 months of observation. This study has been criticized mainly because of the use of a small needle in the laparoscopic group that may have resulted in inadequate tissue bites. More head-to-head comparisons are needed.

The cost of laparoscopic retropubic urethropexy compared to the open approach has been examined in a few studies. One study reported equal costs. Longer hospital stays with the open procedures were balanced by higher operating room and equipment costs in the laparoscopic group. A slightly higher cost in the laparoscopic group was the finding of another group. Increased operating time in the laparoscopic group was cited as a major contributor to the cost.

Needle urethropexies

Needle procedures have yielded vastly different outcomes in different hands. At least part of the problem in studying needle procedures, as a whole, has been the wide range of variation in technique. These procedures as a group have cure rates ranging from 20-88% across studies, with observation ranging from 6 months to 27 years. Both objective and subjective methods of observation are included. Long-term observation of the Pereyra procedure yielded a 10-year success rate of 20%. A 24% success rate was reported with the Raz procedure after 27 months of observation. The Stamey procedure has been shown to have an 18% success rate after 5 years in one study. Another study showed a 33% success rate at 10 years. In an 8-year observation of the Gittes procedure, investigators reported a cure rate of 23% with another 27% improved. Most failures occurred during the first 2 years.

Suburethral slings

Suburethral slings have yielded impressive cure rates rather consistently. Cure rates have ranged from 70-95%. The vast number of reports of sling procedure outcomes are impossible to compare due to differences in observation length; assessment methods; and, most importantly, variations in sling length, sling material, and attachment points. Generally, results have been comparable to the findings for the Burch, although the urodynamic characteristics of the populations studied may differ. Groups chosen to undergo sling procedures often have a high incidence of ISD. Complication rates with sling procedures traditionally have been thought to be higher, although this may be changing. Most worrisome are urinary retention, prolonged catheterization, sling erosions, de novo DI, and infections. The negative quality of life impact of some of these complications actually may exceed that of the original incontinence disorder. The need for revision or removal is not rare.

An overall impression that can be gained from reviewing the literature is that choice of sling material may not affect cure rates as much as it does complication rates. Removal rates of as high as 25% have been reported with some synthetic materials. Sling tension probably is another major determinant of outcome, but this variable is very hard to measure. No standard methods of adjusting sling tension exist, and no studies compare sling techniques directly.

For many years, the presence of ISD and urethral hypermobility has been considered the ideal indication for a suburethral sling. In some studies, retropubic urethropexies have had higher failure rates in this subgroup of patients. Recently, a study demonstrated similar good results using the Burch procedure in this setting. The authors tied the Burch sutures tighter than usual to create a pronounced negative resting cotton swab angle. Another group has used the Ball-Burch variation in patients with ISD and hypermobility with results equivalent to the sling. In a third study, the Burch was compared to the suburethral sling in patients with a MUCP urethral closure pressure less than 20 cm H20. Urethral mobility was described as hypermobile, normal, and rigid. No patients with rigid immobility were included in either group. Specific criteria for classifying mobility were not described. Equivalent subjective and objective success rates were noted.

Little has been reported in the literature concerning the use of sling procedures in cases of GSI without ISD. A report on rectus fascia slings from an experienced group in Texas includes a subgroup of patients with GSI alone. The cure rate in this subgroup was 96%, with an overall cure rate of 93% with an average observation period of 22 months. This same study reported a 75% cure rate of urge incontinence in patients with a mixed disorder. Another group reported on their experience treating each form of incontinence with slings; overall, the combined cure and improvement rate was 94% for stress incontinence and 77% for urge incontinence at 1 year. Finally, another group reported a 69% rate of resolution of urge incontinence with the sling procedure at 3 months of observation. From a video urodynamic standpoint, they attributed their success in treating urge incontinence to achieving bladder neck closure at rest.

A study of sling procedures using cadaveric fascia lata recently was conducted. The outcome was reported in terms of improvement in SEAPI incontinence scores. The researchers noted decreases in the incontinence score from approximately 7 preoperatively to 1 postoperatively in both the allograft and autograft groups. Observation was short. Another study of allografts examined histological specimens after failed sling procedures and sacral colpopexies. Among 35 suburethral sling procedures, 6 failures were reported. All failures occurred between 1 week and 9 months postoperatively. In 4 cases, graft material could not be identified grossly at reoperation. In 2 cases, softened graft fragments were identified in the retropubic tunnels. The group concluded that cadaveric freeze-dried irradiated fascia should not be used for suburethral slings or other pelvic reconstructive procedures pending further research.

The tension-free vaginal tape procedure is a variation of the sling procedure that appears to be less invasive, with a low incidence of postoperative voiding problems and a good success rate. A report on 50 women observed after years showed an 86% cure rate with another 11% improved.

The pubic bone suburethral stabilization sling procedure is a promising operation in which a synthetic mesh is secured to the underside of the pubic bone with titanium screws. In 105 patients with recurrent stress incontinence, approximately 90% were dry and 10% improved with subjective observation in the 4- to 8-year range. Importantly, no cases of osteomyelitis have been reported. This author treats any patient with a vaginal pH of greater than 4.5 with metronidazole for a week before surgery. If the pH is still greater than 4.5 just before surgery, a therapeutic course of antibiotics for 5 days is prescribed.

Reports of sling surgery in men with ISD are sparse. In 1 small series, slings and bladder augmentation were performed in men with neurogenic bladder and urethral incompetency. Sixty-nine percent were completely dry and performing ISC postoperatively. Approximately 15% required collagen injections after the sling. In a group of patients with postradical prostatectomy, 56% were dry after sling placement with another 8% improved. After sling retightening procedures, the total success rate improved to 75%.

A small series from Egypt reported on a mixed group of patients with incontinence due to prostatectomy, myelodysplasia, and spinal cord trauma. At an average of 13 months of observation, 10 of 11 patients were dry. Slings also have been performed in children with neurogenic incontinence. Combined with ISC, continence rates of greater than 90% have been reported. The interest and research in sling procedures are large. Many hope that these investigations will determine which methods and materials result in the best outcomes, in terms of both high cure rates and low morbidity.

Periurethral injections

The short-term results have been good, with cure plus improvement rates ranging from 70-100%. A review of 15 studies with an average of 2 years of observation reported a cure rate of 49%, with a combined cure and improved rate of 67%. The multicenter North American Study Group reported a cure rate of 96% at 1 year. The average number of treatments was 2.5, and the average amount of collagen used to achieve a cure was 24 mL. These figures are greater than were reported in most previous studies.

A recent investigation of 181 women with approximately equal numbers of type I, type II, and type III incontinence reported a cure rate of 23% at 2 years. Improvement and failure rates were 52% and 25%, respectively. The cured group required an average of 1.6 treatments and a mean collagen volume of 5.6 mL. These numbers were 2.9 and 11.4 in the improved group. Several other studies have noted no significant differences in cure rates, number of treatments, or total injection volume when comparing ISD patients with and without urethral hypermobility.

A small study of patients with neuropathic urethras described 7 of 11 patients as cured or improved after periurethral collagen injections. They reported an increase in the Valsalva leak point pressure from a pretreatment mean of 60 cm H20 to a posttreatment value of 117 cm H20. The periurethral and transurethral techniques were compared in a recent study of 45 women. With short-term observation only, cure and improvement rates were similar. The average amount of collagen used in the periurethral group was significantly greater; yet, the average number of treatments was the same. In men, the short-term efficacy of transurethral collagen injections has been well demonstrated.

A recent study followed the cases of 68 men with ISD due to various forms of prostate surgery. With a mean observation of 36 months, the cure rate was 10%, with an additional 10% experiencing marked improvement. These relatively poor long-term results occurred despite an average of 5 treatments and an average total injection volume of 36 mL. A subgroup with incontinence after transurethral prostate resection did better than groups with more radical surgery.

Artificial urethral sphincter

The AUS has been used with improving results for years in severe cases of sphincteric incontinence. In women, success rates of 91-100% have been reported. Mechanical complications requiring repeat surgery occurred in 21%. Considerably more experience exists with this device in men. A recent French study demonstrated complete dryness in 61% and considerable improvement in an additional 28% in a group of men with postprostatectomy incontinence. The revision rate was 21%. In a high-risk population, after radical pelvic surgery and radiation therapy, socially acceptable continence was achieved in 91% of patients. The need for revision was 38%. A study of 166 patients with a mean observation period of 42 months reported 75% as dry or nearly dry and an additional 15% as improved. Forty reoperations were reported.

In pediatric patients with congenital neurogenic incontinence, the artificial sphincter is the operative therapy of choice. Success rates of 85-90% have been reported. Enterocystoplasty has been combined successfully with artificial sphincter placement. The authors emphasize that good bowel preparation, IV antibiotics, and sterile urine are important factors in reducing infectious complications. In addition, entrance into the augmented bladder during sphincter placement should be avoided.

The long-term outcome in a group of patients with artificial sphincters for 10-15 years recently was reported. Sixty-one percent of patients were continent and were using the device. Another 14% had died but were believed to be continent just before death. The sphincter had failed and was abandoned in 15% of the patients. Of note, 80% of patients required 1 or more revision. Only 13% were continent with the originally implanted device. This report and others have shown that complications and the need for revision are high and both physician and patient should anticipate the possibility of future surgery. The issue of incontinence after artificial sphincter placement was addressed in a recent study. The authors found these incontinence problems could be addressed successfully approximately 90% of the time.

In summary, artificial sphincters are useful in severe sphincter deficiency, including congenital neuropathic and postprostatectomy incontinence. Cure rates are high, but the need for revision, replacement, and further surgery likewise are high. With close observation and diligence, most postoperative complications and failures can be addressed.

Surgical versus medical treatment

No studies prospectively compare surgical and nonsurgical therapy for GSI. Retrospective analysis of cure rates, if undertaken, probably would not be valid because the populations undergoing surgical and nonsurgical therapy may differ. Often, less severe cases of incontinence are considered for medical management or cases in which a contraindication to surgery exists.

Pregnancy after incontinence surgery

Little solid data exist to guide clinical decisions in this area. Eight cases of MMK procedures following pregnancy have been reported. Seven patients delivered vaginally and 1 by cesarean delivery. All remained continent in the short-term following delivery. A survey of members of the American Urogynecology Society (AUGS) membership recently was conducted to address this issue. Forty vaginal deliveries and 47 cesarean deliveries following incontinence surgery were reported. Among women with vaginal deliveries, the subsequent continence rate was 73%, compared to 95% following cesarean deliveries. This retrospective analysis is subject to recall bias, but it represents the best data to date. Most incontinence surgeons recommend cesarean delivery following incontinence surgery. Whether surgery should be performed if women consider bearing more children remains unanswered.

Fistula repair

Most studies show successful closure of urogenital fistulae in approximately 90% of cases. Importantly, most of these are simple vesicovaginal fistulae of small-to-moderate size resulting from gynecological surgery mishaps. The results of treating larger and more complex fistulae are less clear.

A recent study sought other urodynamic diagnoses in a group of 38 patients with genitourinary fistulae. The study found additional disorders in 83% of the patients. Fifteen of 38 patients had more than 1 additional diagnosis. Overall, 47% had GSI, 40% had DI, 17% had impaired bladder compliance, and 50% had voiding dysfunction. GSI and DI were found more commonly in urethrovaginal and bladder neck fistulae. After surgical treatment of the fistula, 92% were cured of incontinence problems. DI was the most common persistent abnormality. This study points out that additional urodynamic diagnoses are common in individuals with urogenital fistulae, and surgical correction eliminates the additional problems in most patients. DI is the most common additional abnormality that persists after surgery. These findings bring to light important considerations in counseling and treating patients with urogenital fistulae.

Urethral diverticulum repair

Success rates of approximately 90% can be expected with good surgical technique. Coexisting GSI and/or ISD are not uncommon. Small series suggest that incontinence procedures, such as suburethral slings, can be combined safely with urethral diverticulum repair.

Cost-effectiveness of incontinence operations

The cost-effectiveness of surgical approaches to stress incontinence has not been studied directly. An interesting recent report used objective cure rates from prospective and retrospective studies of incontinence procedures and hospital cost data from third-party payers to estimate the cost-effectiveness of 3 common incontinence procedures. The estimated cost per cure at 5 years was $7878 for the Burch colposuspension, compared to over $13,000 for both the modified Pereyra procedure and anterior colporrhaphy. These long-term findings were in contrast to the immediate costs that were lowest for the anterior repair followed by the modified Pereyra and Burch procedures, respectively. More cost analysis research concerning incontinence treatment most likely will be performed in the future.

Therapeutic index of stress incontinence surgery

The concept of a therapeutic index traditionally has been applied to pharmacologic interventions only. Calculation of the index requires knowledge of the median effective dose and the median toxic dose. A recent publication proposed the application of the concept of therapeutic index to incontinence surgery. The authors proposed using the median percent cure rate and the median percent complication rate as variables. The preliminary findings of the study show the anterior colporrhaphy as having the highest therapeutic index, mostly due to very low complication rates. Needle procedures had the worst (ie, lowest) therapeutic index, with retropubic procedures and sling procedures falling in the middle.

The study has many flaws, including incomplete data on the sling procedure and lack of consideration of complications and failures at reoperation in the overall formula. Despite the flaws, the concept of a surgical therapeutic index is exciting and may make decision making for both the patient and the physician easier, in terms of the choice of surgical procedure.

Detrusor instability

Data regarding the long-term results of the treatment of DI are sorely lacking. Recently, over 1000 patients received follow-up care after a minimum of 6 months. Most of these patients (90%) were treated with anticholinergic medications for their urge incontinence. Only 5.5% were cured at the time of observation. Another 48% reported significant improvement. Only 18% continued with their medication beyond 6 months. Of those patients treated with bladder reeducation drills, 75% reported cure or significant improvement. The patients in this study were diagnosed with DI based on urodynamic findings in addition to a history and physical examination.

FUTURE AND CONTROVERSIES ¡@

Interest and research in the specialty of urogynecology has been increasing. With this increased interest, exciting innovations appear to be forthcoming.

Minimally invasive surgical approaches are being investigated, and many of these approaches appear promising. The laparoscopic approach to retropubic urethropexy is especially attractive due to the improved visualization and hemostasis afforded by this mode of access. Procedures using new materials, such as mesh, staples, and corkscrews, are tempting to use because of their simplicity of application, compared to laparoscopic suturing. Equivalent outcomes with open or even laparoscopic Burch procedures (using suture) cannot be assumed; therefore, these new methods should be compared to existing methods in scientific studies and found to be safe and efficacious before being adopted widely. Unfortunately, consumer and marketing pressures have resulted in the use of these procedures and products before they have been studied adequately.

Vaginal dissection for the treatment of pelvic support disorders and urinary incontinence has been scrutinized recently regarding the potential for pelvic floor denervation. The existing evidence demonstrates that vaginal approaches result in more denervation injury than abdominal approaches. Recovery of some of the lost neurologic function has been observed over time. Whether denervation injury results in poorer long-term outcomes in the vaginal surgery group is not yet answered. This controversy has served to increase interest in the laparoscopic approach. Laparoscopic pubovaginal sling procedures may carry the theoretical advantage of less denervation injury and, possibly, less postoperative sexual discomfort. Initial attempts at this approach to sling surgery have been disappointing, but a great deal of interest remains.

The use of suburethral sling procedures, in general, is surging because of their efficacy, durability, and flexibility as an incontinence procedure. A strong advantage of sling procedures over other incontinence procedures is the ability to treat coexisting GSI due to hypermobility and ISD effectively. Some urogynecologists and urologists believe that sling procedures should be the incontinence procedure of choice. Proponents state that using the sling procedure obviates the need to identify ISD preoperatively in patients with stress incontinence because the operation treats both hypermobility and sphincteric problems. Opponents state that sling procedures are associated with increased postoperative morbidity, including obstruction, voiding dysfunction, and erosion of sling material. Many experts believe that tying the sling with little or no tension can minimize these complications.

The choice of sling material is an area of ongoing controversy. The ideal sling material has not been found. Artificial materials have the advantages of excellent strength, durability, and availability. The major disadvantages are increased rates of infection, rejection, and erosion of sling material. Endogenous fascia enjoys the advantage of low complication rates but requires additional incision(s) and intraoperative time for harvesting, and, in many instances, endogenous connective tissue may be of suspect quality. Cadaveric donor fascia is an attractive alternative due to low rejection and erosion rates and the avoidance of additional incisions. The quality of the highly processed endproduct may vary considerably. Suture pull-out can be a problem. Whether autolysis of this tissue in vivo may compromise long-term efficacy is uncertain. Finally, DNA has been found in some samples of donor fascia. The theoretical risk of disease transmission still is a concern.

Tissue engineering is an exciting biologic breakthrough that may allow growing tissues and even organs in the laboratory. People with incontinence with such disorders as bladder extrophy and epispadias may benefit greatly from this advancement. In addition, this technology may be applicable to patients with bladders damaged by disease, radiation, trauma, and cancer.

BIBLIOGRAPHY ¡@