Demographic, medical, and physiologic predictors of behavioral treatment and pharmacotherapy success would be useful in selecting treatments for specific patients with urinary incontinence based on their histories, physical examinations, and urodynamic profiles. The author performed a systematic review of clinical trials of behavioral treatment or pharmacotherapy for urinary incontinence. Most postulated predictors (age, type and duration of incontinence, medications including diuretics and estrogen, obstetric history, physical examination, and urodynamic findings) were not predictive of treatment outcomes. For behavioral therapy, male gender predicted worse outcomes in 1 study, but it was not a predictor in 2 other studies. Greater severity of incontinence predicted positive outcomes in 2 studies, negative outcomes in 3 studies, and had no predictive value in 5 studies. Prior treatment for incontinence predicted poorer outcomes in 2 studies of urge incontinence but was not predictive in a study of stress incontinence. Prior surgical treatment predicted better outcomes in 1 study of urge incontinence in women but was unrelated in 4 studies. Male gender, depression, or the use of assistive devices for ambulation predicted poorer outcomes in homebound older persons. For pharmacotherapy of urge incontinence, older age, female gender, and greater incontinence severity were associated with poorer outcomes in 1 study. Age was unassociated with outcomes in another study. Thus, the literature on predictors of outcomes of behavioral and drug treatment for urinary incontinence is inconsistent and does not provide guidelines for treatment selection. More studies, with large samples, that use multivariate regression analysis to examine predictors of outcomes are needed.

Identification of physiologic factors that predict response to fecal incontinence therapy would be helpful in choosing the optimal treatment and advising patients on the likelihood of a successful outcome. However, few physiologic parameters have been consistently identified as important in predicting response to either biofeedback or surgery. The process of isolating these factors has been hampered by heterogeneity in the definition of fecal incontinence, lack of consensus on what constitutes a successful outcome, lack of follow-up data, variations in the way "standard" treatments are implemented, and lack of properly powered randomized controlled trials. Among the physiologic variables that studies have generally found to be predictive of successful outcomes in biofeedback treatment are the threshold for external anal sphincter contraction after treatment, the inclusion of sensory training in treatment, and a reduction in volume for the first sensation after treatment. Factors that have not been found to be important in predicting outcome following biofeedback retraining include the duration of fecal incontinence, pudendal nerve damage, patient age, symptom severity, pretreatment anal canal pressures, and results of anal ultrasonography. The presence of some degree of anorectal sensation is the only preoperative assessment that has been found to be predictive of response to surgical therapy. It is recommended that outcome measures for fecal incontinence be more clearly defined, that future biofeedback studies elaborate the predictive value of pretreatment anorectal sensation and the response to sensory retraining, and that postsurgical measurements such as anal squeeze pressure and sphincter length be taken into account.

This report reviews the advantages and disadvantages of 2 types of outcome assessment regularly used in the literature on incontinence: (1) global assessments of symptoms or relief and (2) ratings of specific symptoms of incontinence. Global assessments are usually used when the target condition involves multiple and variable symptoms. They are easy for patients to understand and yield data that seem to correspond closely to the target of the treatment (e.g., symptom severity). The 2 major scaling approaches used in clinical symptom assessment, categorical scaling and cross-modality matching of symptom intensity to line length (visual analogue scales), are reviewed for their reliability and validity. Numerical scales provide the advantage of a large number of possible ratings (usually 9-100) and are intuitively easy to use. All methods of symptom assessment using patient recall are subject to potential reporting bias. Measures of current symptoms, although less biased, may not reflect ongoing symptom levels, and current symptom levels tend to influence patients' recall of both symptom severity and medication counts. However, patient-initiated ratings are relevant to assessing "real-time" symptoms in incontinence trials, and even single retrospective ratings of "usual" symptom intensity may actually be an adequate reflection of the average symptom severity (at least for chronic pain). Applying subjective, predetermined criteria for success, such as the provision of "adequate relief," allows researchers to closely mimic clinical situations and use a cutoff point ("threshold") specifically associated with the condition and treatment being investigated. Devices such as personal digital assistants that can cue subjects for information at set or random intervals, record multiple types of responses, and accurately assess compliance with data recording should help facilitate future research.

Cross-cultural research often involves physicians, nurses, and other health care providers. In studies of fecal and urinary incontinence, cross-cultural research has been applied to quality-of-life comparisons, and instruments have been translated to foreign languages for use in other countries. This report presents some of the principal methodological issues and problems associated with translating questionnaires for use in cross-cultural research in a manner relevant to clinicians and health care practitioners who are aware that, unless these potential problems are addressed, the results of their research may be suspect. Translation is the most common method of preparing instruments for cross-cultural research and has pitfalls that threaten validity. Some of these problems are difficult to detect and may have a detrimental effect on the study results. Identification and correction of problems can enhance research quality and validity. A method for translation and validation is presented in detail. However, the specific validation method adopted is less important than the recognition that the translation process must be appropriate and the validation process rigorous.

Symptoms of incontinence are common, particularly among older people, and incontinence can have a severe effect on the quality of life of some individuals at any age. A number of treatments are available, most of which aim to reduce the occurrence of incontinent episodes or to limit the effects of the disorder on everyday life. In research and clinical practice, it is essential that the symptoms and effects of incontinence be properly assessed and recorded. The only valid means of measuring patients' perspectives is through the use of psychometrically robust self-report questionnaires. Incontinence may be experienced as part of the symptom complex of a range of conditions (e.g., benign prostatic diseases or fistulas), and the effect of incontinence on quality of life varies depending on the severity of the condition and other psychosocial and medical factors. Questionnaires with acceptable levels of psychometric testing are identified and recommended for use in clinical practice and research investigations according to the following categories: (1) questionnaires to assess symptoms of incontinence, (2) generic health-related quality-of-life questionnaires to assess the effect of incontinence on quality of life, and (3) incontinence-specific measures to assess the effect and bothersomeness of incontinence on quality of life.

This article reviews self-reporting instruments to measure severity and quality of life in fecal incontinence. Severity instruments assess the frequency, type, and amount of stool loss and the impact of fecal incontinence on coping mechanisms and lifestyle/behavioral change. Non-weighted instruments use simple numerical totals to gauge severity; however, the use of vague quantifiers to describe severity can make the results highly subjective. In weighted surveys, every possible response (indicating the frequency of each type of incontinence) is multiplied by a weight that reflects the average severity assigned by a representative group of patients (or physicians), and the weighted responses are added to compile a total score. When variables such as coping mechanisms and lifestyle changes are included in severity questionnaires, the results tend to reflect patient functioning more than severity and should be interpreted cautiously. Quality-of-life scales assess variables that are not directly observable and are highly subjective. Quality-of-life scales are divided into 3 categories: (1) generic scales permit the measurement of gross change and compare the experience of the target population to other populations; (2) specialized scales are most useful in trying to isolate effects of specific variables, such as depression; and (3) condition-specific quality-of-life scales measure the relationship between specific medical conditions or treatments, and quality of life outcomes. Future research should focus on the need for weighting, further evaluation of the use of coping mechanisms as an indicator of severity, and how to integrate measures of urgency. In the area of quality of life, "modules" are needed that can be appended to established instruments to help assess and compare the experience of specific populations.

Physiologic outcome measures are divided into 2 groups: (1) measures that visualize, quantify, and analyze the reasons for urine loss and (2) measures that assess the anatomy and neuromuscular function of continence-related structures. Few of the frequently used physiologic outcome measures have been rigorously tested. The evidence in support of their use derives mainly from case series information and expert opinion. Perineal pad testing is used to quantify urine leakage associated with stress incontinence. One-hour pad tests are commonly used for clinical trials and office visits; 24- and 48-hour tests are more reliable and reproducible. Urodynamic testing simultaneously assesses bladder and urethral function during bladder filling and emptying to help guide therapy and identify patients who are at risk for surgical failure. Testing usually includes (1) uroflowmetry, an assessment of voiding without catheters in place; (2) cystometry, which assesses bladder sensation, capacity, compliance, and inappropriate detrusor activity during filling; (3) urethral pressure profilometry, to gauge urethral closing pressures and pressure transmission ratios; (4) leak-point pressure, the minimum intra-abdominal pressure required to cause incontinence, which serves as a measure of urethral function; and (5) pressure flow studies, which diagnose obstruction by evaluating detrusor pressure and flow rate during voiding. The cotton swab test is used to assess bladder neck mobility after surgical interventions. Using the Pelvic Organ Prolapse Quantification system, researchers can describe pelvic support in a standardized, reproducible fashion. Applications of ultrasonography and magnetic resonance imaging in urogynecology are promising but remain in the investigational stages.

Fecal incontinence is a symptom attributable to a variety of disorders affecting one or more factors that maintain continence. Objective assessments should complement symptom assessments as outcome measures in therapeutic trials; conceivably, these assessments may also predict the response to therapy. Consistent with existing trends, most therapeutic trials should incorporate anal sphincter pressures and rectal sensation as outcome variables, paying meticulous attention to techniques. Rectal sensation is increased after pelvic floor retraining by biofeedback therapy in fecal incontinence; however, the predictive value of improved anal pressures after biofeedback has not been clearly established. Other factors maintaining continence can be assessed by newer approaches. In addition to assessing rectal sensation, a barostat also measures rectal compliance; alterations in rectal compliance modulate rectal perception. Particularly appropriate end points for trials involving surgical repair are sphincter integrity, assessed by endoanal ultrasound or magnetic resonance imaging (MRI), and puborectalis and pelvic floor motion, assessed by dynamic MRI. Despite disagreement about which technique is superior for evaluating the internal sphincter, MRI performs the same or better than ultrasound for assessing the external sphincter. The utility of measuring pudendal nerve latencies as a marker of pudendal nerve injury is limited; needle electromyography provides a sensitive measure of denervation and can usually identify myopathic damage, neurogenic damage, or mixed injury. These standardized, reproducible assessments of the multifaceted mechanisms maintaining fecal incontinence should be incorporated as outcome variables in therapeutic trials of fecal incontinence.

Behavioral treatments improve bladder control by changing the incontinent patient's behavior, especially his or her voiding habits, and by teaching skills for preventing urine loss. These treatments are effective for most outpatient men and women with stress, urge, or mixed incontinence. The average reduction in the frequency of incontinence ranges from 57% to 86%. In long-term care settings, treatment is generally more challenging and yields more modest results. The advantages of behavioral interventions include the absence of side-effects, patient comfort, and high levels of patient satisfaction. Although most patients who receive behavioral treatment achieve significant improvement, most are not completely dry. Thus, there is a need for research to explore ways to enhance the effectiveness of these conservative therapies. Combining behavioral treatment with other treatments may have additive effects. Research is also needed to understand better the mechanisms of therapeutic change, the best methods for teaching pelvic floor muscle control, the optimal exercise regimens, the predictors of outcome, and the efficacy of behavioral treatments in men. Although behavioral interventions are more accepted today than 20 years ago, they are still not widely available or integrated into most clinical practices, and we know little of how effective they will be in these settings. Thus, it will be important to develop and evaluate creative modes of delivery, such as group intervention (especially by nonphysician providers), in a variety of clinical settings.

Treatment options for urinary incontinence include behavioral techniques, pharmacologic agents, and surgical procedures. Caregivers use pharmacotherapy heavily because of its availability, immediacy of results, and convenience. However, only pharmacotherapy for urge incontinence has advanced to the level at which several drugs that have undergone rigorous scientific testing using randomized controlled trials have received FDA approval; these are the antimuscarinic and anticholinergic/direct smooth muscle relaxant drugs. However, promising new drugs targeting other receptors are under investigation. There is no FDA-approved drug for stress incontinence or overflow incontinence. Pharmacologic clinical trials for urinary incontinence are no different than pharmacologic trials in other areas. A randomized controlled trial is the best approach for documenting effectiveness and safety. A rigorous trial should include identification of primary and secondary outcomes. The measurement tools of outcomes must be reliable and validated. Preferably, the severity level of urinary incontinence should be established, and measurement of effectiveness must include durability. Not only must side effects be identified, but their impact on the quality of life must be quantified. An exciting area in pharmacologic treatment of urinary incontinence is the method of drug delivery. In addition to sustained release oral medication, the transdermal patch and the intravaginal route are starting to be used in clinical practice. The intravesical route is still in the investigational phase. Pharmacologic research for urinary incontinence is now entering an exciting time because technologic advances are creating new agents with more precise targeting and more sophisticated methods of delivery are being developed and tested.

Urinary incontinence affects many Americans, predominantly women. The majority of health care costs are spent on absorbent products, and diagnosis and treatment consume significant additional resources. Many factors interact with urinary incontinence-including medications, health conditions, and other pelvic floor disorders. There has been no meaningful research on prevention of urinary incontinence. The majority of research has focused on treatment, often with medical approaches or surgery. Surgery for urinary incontinence is largely limited to treatment of stress urinary incontinence. Nearly 300 procedures have been proposed, but very few have been the subject of significant, high-quality research. Three groups of surgical procedures (and their variants) have been utilized over the past decades: urethropexy, colposuspension, and the sling. Effective surgery appears to result from enhancing sphincteric closure during increases in intra-abdominal pressure. There are only a few studies that compare these procedures to one another. Many surgical procedures are adopted based on expert opinion and novel, untested concepts. A significant number of postoperative patients experience continued incontinence despite "cure" of stress incontinence. Research in the field of surgery for urinary incontinence can be facilitated by development of better diagnostic aids, better outcome measures, and techniques that allow standardization of interventions and testing procedures (including urodynamics). The role of industry needs close scrutiny-because novel, untested techniques and materials are frequently introduced without careful human subjects testing. Although surgery will continue to play an important role in the treatment of urinary incontinence for Americans, high-quality studies are urgently needed in this field.

Biofeedback has been advocated as first-line therapy for patients whose symptoms of mild to moderate fecal incontinence have not responded to simple dietary advice or medication. Three main modalities have been described: (1) use of an intra-anal electromyographic sensor, a probe to measure intra-anal pressure, or perianal surface electromyographic electrodes to teach the patient how to exercise the anal sphincter; (2) use of a 3-balloon system to train the patient to correctly identify the stimulus of rectal distention and to respond without delay; and (3) use of a rectal balloon to retrain the rectal sensory threshold, usually with the aim of enabling the patient to discriminate and respond to smaller rectal volumes. Although a systematic review found that biofeedback eliminated symptoms in up to one half of patients and decreased symptoms in up to two thirds, these studies suffered from methodological problems, a lack of controls, and a lack of validated outcome measures. No studies have compared different exercise instructions, measured patient compliance with those instructions, or determined any trends in symptom response to the exercises prescribed. A recent study by the author suggests that patient-therapist interaction and patient coping strategies may be more important in improving continence than performing exercises or receiving physiological feedback on sphincter function. Better-designed randomized, controlled trials are needed to evaluate different exercise programs and different elements of biofeedback. Development and validation of outcome measures are important, and predictors of outcome and effects in patient subgroups, especially elderly and neurologically impaired patients, should also be investigated.

Diarrhea and constipation are known risk factors for fecal incontinence. This report reviews how to diagnose and medically treat patients with chronic diarrhea, chronic constipation with overflow incontinence, and incontinence resulting from rectal mucosal prolapse secondary to hemorrhoids. Antidiarrheal agents (including loperamide, diphenoxylate, and difenoxin) and the tricyclic antidepressant amitriptyline improve continence in patients with diarrhea-associated incontinence. Other antidiarrheal agents are under investigation. The mechanism is believed to be decreased intestinal motility and stool frequency resulting in more formed stools. Increases in anal canal resting pressure may also contribute to improvement in continence. Adverse effects are constipation from excessive use. In addition to antidiarrheal drugs, fiber supplements may improve incontinence associated with diarrhea. Transient, benign cases of constipation usually respond to increasing fluid intake and dietary fiber, improving mobility, or eliminating the concurrent use of constipating drugs. For mild to moderate constipation, bulking agents, laxatives, and stool softeners are used cautiously so as not to excessively loosen stools and exacerbate anal incontinence. Laxatives have been shown to improve continence, possibly through the mechanism of eliminating fecal impaction. Prolapsing hemorrhoids may partially obstruct defecation and cause soilage from the passage of fecal material, mucus, or blood. With endoscopic banding, a ligator is attached to an endoscope and a tight band is placed around the enlarged vein, causing the hemorrhoid to thrombose.

Although surgical therapy has been shown to be an effective treatment of anal incontinence, few properly controlled randomized studies have confirmed its efficacy or compared it with biofeedback or other less invasive forms of treatment. Overlapping sphincteroplasty, the most common procedure, seems to confer substantial benefits on patients with sphincter disruptions. However, recent data suggest that results following sphincteroplasty deteriorate with time. There is also disagreement about whether pudendal nerve conduction studies can be used to predict outcome after surgical repair. Salvage options for patients with refractory fecal incontinence include passive or electrically stimulated muscle transfer procedures, implantation of an inflatable artificial anal sphincter, and sacral nerve stimulation. Stimulated graciloplasty is the most commonly used muscle transfer procedure; good to excellent results are reported from a small number of high-volume centers, but multicenter trials with less experienced surgeons have shown a high morbidity rate associated with the procedure. The artificial anal sphincter provides good restoration of continence for most patients who retain the device, but a significant explantation rate due to infection or local complications remains problematic. Sacral nerve stimulation has shown promising early results with minimal associated morbidity. There is a critical need for controlled long-term studies that use objective data collection methods, standardized outcome measures, and validated quality-of-life assessment instruments.

Urinary and fecal incontinence affect 50% or more of nursing home residents and frequently occur together because immobility and dementia are primary risk factors for both conditions. Many residents (40%-60%) show immediate improvement when provided with consistent toileting assistance, which compensates for the immobility and dementia risk factors that prevent them from toileting independently. Residents who are responsive to assistance can be identified with a 2-day run-in trial during which prompts are provided every 2 hours to encourage toileting. This run-in trial also provides an opportunity to use protocols to identify and treat other reversible causes of incontinence (e.g., urinary tract infection, fecal impaction) and to diagnose problems with bladder or anorectal functioning. The effects of toileting assistance on the frequency of fecal incontinence, while significant, are less dramatic than those reported for urinary incontinence, primarily because of constipation. Fortunately, noninvasive interventions have been identified that address most of the risk factors common to both constipation and fecal incontinence. Trials are needed to evaluate treatments that integrate noninvasive interventions directed toward the use of laxatives or constipating agents, low toileting frequency, low food and fluid intake, and physical activity to improve constipation and fecal incontinence in nursing home residents. The scientific documentation of the efficacy of such a noninvasive intervention and the labor costs of implementing these measures can lead to major changes in how nursing home care is funded and provided.

This article addresses the diagnosis and treatment of pediatric fecal incontinence in 4 main categories: (1) Functional fecal retention, the withholding of feces because of fear of painful defecation, results in constipation and overflow soiling. Treatment includes dietary changes, use of laxatives, and cognitive and behavioral interventions such as toilet training, which diminishes phobia and provides positive reinforcement through a rewards system. (2) For functional nonretentive fecal soiling (encopresis), antidiarrheal agents can increase the consistency of stools and facilitate continence. Anorectal biofeedback for children has been proposed, but its efficacy remains unproven. Parents should be educated to conduct nonaccusatory toilet training and help children alleviate guilt and enhance self-esteem. Appropriately constructed trials are necessary to gauge the effect of adding prolonged use of enemas to an intensive toilet training program. (3) Surgery can correct minor congenital anorectal anomalies by identifying the external sphincter, separating the rectum from the genitourinary tract, and reconstructing the anus. However, there is great variation in postsurgical functional outcomes for anorectal malformations. Double-blinded, randomized controlled trials could help define the role of appendicostomy, cecostomy, sphincter reconstruction, colostomy, and artificial sphincters. (4) Children with spina bifida and fecal incontinence may benefit from techniques that teach them how to defecate. A continent appendicostomy (Malone procedure) is a promising treatment that completely cleanses the colon, increases the child's autonomy, and decreases the chance of soiling. A cecostomy can be performed surgically, endoscopically, or radiologically to provide some of the same benefits.

The anatomic structures that prevent stress incontinence, urinary incontinence during elevations in abdominal pressure, can be divided into 2 systems: a sphincteric system and a supportive system. The action of the vesical neck and urethral sphincteric mechanisms at rest constrict the urethral lumen and keep urethral closure pressure higher than bladder pressure. The striated urogenital sphincter, the smooth muscle sphincter in the vesical neck, and the circular and longitudinal smooth muscle of the urethra all contribute to closure pressure. The mucosal and vascular tissues that surround the lumen provide a hermetic seal, and the connective tissues in the urethral wall also aid coaptation. Decreases in striated muscle sphincter fibers occur with age and parity, but the other tissues are not well understood. The supportive hammock under the urethra and vesical neck provides a firm backstop against which the urethra is compressed during increases in abdominal pressure to maintain urethral closure pressures above rapidly increasing bladder pressure. The stiffness of this supportive layer is presumed to be important to the degree to which compression occurs. This supporting layer consists of the anterior vaginal wall and the connective tissue that attaches it to the pelvic bones through the pubovaginal portion of the levator ani muscle and also the tendinous arch of the pelvic fascia. Activation of the levator muscle during abdominal pressurization is important to this stabilization process. The integrity of the connection between the vaginal wall and tendinous arch also plays an important role.

Fecal incontinence occurs when the normal anatomy or physiology that maintains the structure and function of the anorectal unit is disrupted. Incontinence usually results from the interplay of multiple pathogenic mechanisms and is rarely attributable to a single factor. The internal anal sphincter (IAS) provides most of the resting anal pressure and is reinforced during voluntary squeeze by the external anal sphincter (EAS), the anal mucosal folds, and the anal endovascular cushions. Disruption or weakness of the EAS can cause urge-related or diarrhea-associated fecal incontinence. Damage to the endovascular cushions may produce a poor anal "seal" and an impaired anorectal sampling reflex. The ability of the rectum to perceive the presence of stool leads to the rectoanal contractile reflex response, an essential mechanism for maintaining continence. Pudendal neuropathy can diminish rectal sensation and lead to excessive accumulation of stool, causing fecal impaction, mega-rectum, and fecal overflow. The puborectalis muscle plays an integral role in maintaining the anorectal angle. Its nerve supply is independent of the sphincter, and its precise role in maintaining continence needs to be defined. Obstetric trauma, the most common cause of anal sphincter disruption, may involve the EAS, the IAS, and the pudendal nerves, singly or in combination. It remains unclear why most women who sustain obstetric injury in their 20s or 30s typically do not present with fecal incontinence until their 50s. There is a strong need for prospective, long-term studies of sphincter function in nulliparous and multiparous women.

Failure to control the elimination of urine or stool causes psychological stress, complicates medical illnesses and management, and has major economic consequences. Patients often describe the impact of both fecal and urinary incontinence in terms of shame and embarrassment and report that it causes them to isolate themselves from friends and family. Incontinence frequently results in an early decision to institutionalize elderly relatives because families have difficulty coping with incontinence at home. Not surprisingly, there is an increase in symptoms of depression and anxiety in patients with incontinence as well as degradation in quality of life that has been documented by standardized assessment instruments. The direct health care costs for urinary incontinence are estimated to be 16.3 billion dollars per year (1995 costs). Separate cost estimates for fecal incontinence are not available. There is an acute need for methodologically sound studies to document the economic and personal impact of incontinence to develop guidelines for the allocation of health care resources and research funding to this major public health problem. This need is especially great for fecal incontinence, for which there is much less health care economic data than for urinary incontinence.

Nursing home residence is by far the most prominent association with fecal incontinence, with a prevalence approaching 50%. In one major survey, urinary incontinence was the greatest risk factor for developing fecal incontinence, and fecal incontinence was the greatest risk factor for developing urinary incontinence. Immobility, dementia, and the use of physical restraints were also important risk factors. Specific diseases associated with fecal incontinence include diabetes, multiple sclerosis, Parkinson's disease, stroke, and spinal cord injury. The surgical procedures lateral internal sphincterotomy for anal fissure, fistulotomy, and ileal pouch reconstruction can result in fecal incontinence. Children who are born with congenital abnormalities, such as imperforate anus, often experience soiling for many years. Future studies to determine the prevalence and etiology of fecal and urinary incontinence will need to first define these conditions and eliminate referral bias. Epidemiologic investigations of both disorders should be performed jointly because the conditions are so often comorbid.