AHCPR
Guideline on Urinary Incontinence - 1996AHCPR
Guideline on Urinary Incontinence - 1996Urinary incontinence (UI) plagues 10-35 percent of adults and at least half of the 1.5 million nursing home residents in the United States. Because of the social stigma of UI, many sufferers do not even report the problem to a health care provider. In addition, when it is reported, many physicians and nurses, who need to be educated in this area, fail to pursue investigation of UI. As a result, this medical problem is vastly underdiagnosed and underreported.
The prevalence of UI, its toll on physical and psychological health, large variations in UI care practices and costs, and the urgent need to educate health care providers and the public about this condition prompted the selection of UI as a clinical guideline topic.
The purpose of this guideline is to improve reporting, diagnosis, and treatment of UI; reduce variations in clinical practice; educate health care providers and consumers about this condition; and, finally, encourage further biomedical, clinical, and cost research on UI. The guideline should help clinicians, caregivers, patients, and patients' families understand the assessment, management, and treatment of UI in adults. Specific reimbursement issues are not addressed.
The guideline recommendations apply to the diagnosis and treatment of acquired incontinence in ambulatory and nonambulatory patients in outpatient, inpatient, and long-term care settings. Not addressed are extraurethral UI, which is involuntary loss of urine through channels other than the urethra, UI in children, and UI due to neuropathic conditions.
To develop and update the guideline AHCPR convened a multidisciplinary, private-sector panel of physicians, nurses, allied health professionals, and health care consumers. The panel conducted extensive literature reviews of UI in adults, heard public testimony at national hearings, and examined information gathered from consultants. It studied the effectiveness and appropriateness of diagnostic and treatment procedures for UI, how they affect outcomes important to patients, their benefits and adverse consequences, and costs incurred from their use.
The panel found evidence in the literature that the treatment of UI can improve or "cure" most patients. It determined that UI in the adult requires a comprehensive approach by health professionals in the initial evaluation and treatment with behavioral and pharmacologic interventions and requires specialists for further diagnostic evaluation and surgical intervention.
The guideline provides practice recommendations in three areas:
This is an update of the guideline, Urinary Incontinence in Adults first published in March 1992. This update reflects new research findings and experience with emerging technologies and innovative approaches for UI assessment and relief. The Agency for Health Care Policy and Research and the guideline development panel welcome comments and suggestions regarding the current guideline. Please address written comments to: Director, Office of the Forum for Quality and Effectiveness in Health Care, Agency for Health Care Policy and Research, 6000 Executive Boulevard, Suite 310, Rockville, MD 20852.
Behavioral Therapy Sections Included below:
Teaching women PMEs may prevent UI. (Strength of Evidence = C.)
Teaching exercises to strengthen pelvic muscles may decrease the incidence of UI. (Strength of Evidence = C.)
PMEs are strongly recommended for women with SUI. (Strength of Evidence = A.)
PMEs are also recommended in men and women in conjunction with bladder training for urge incontinence. (Strength of Evidence = B.)
PMEs may also benefit men who develop urinary incontinence following prostatectomy (Strength of Evidence = C.)
PMEs, also called Kegel exercises and pelvic floor exercises, are performed to strengthen the voluntary periurethral and perivaginal muscles (i.e., voluntary urinary sphincters and levator ani) that contribute to the closing force of the urethra and to the support of the pelvic visceral structures.
The first step in pelvic muscle re-education is to establish better awareness of pelvic muscle function. PMEs are performed by "drawing in" or "lifting up" of the perivaginal muscles and anal sphincter as if to control urination or defecation with minimalcontraction of abdominal, buttock, or inner thigh muscles Rose, Baigis-Smith, Smith, et al., 1990). Patients are generally told to sustain a contraction for at least 10 seconds, followed by an equal period of relaxation. The exercises should be performed about 30-80 times a day for at least 8 weeks and may need to be continued indefinitely. Elderly patients may require a longer time to train. In general, an individualized program of exercises and repetitions should be tailored to enhance muscle strength progressively Ferguson, McKey, Bishop, et al., 1990). To condition the muscle to contract with increases in intra-abdominal pressure, patients should be taught to contract the pelvic muscles before and during situations when leakage may occur.
The specific effects of PMEs on actual lower urinary muscle function is not completely understood; some studies show a relationship between changes in various measures of pelvic floor strength, such as anal sphincter strength or maximum urethral closure pressure, and reduction in incontinence (Benvenuti, Caputo, Bandinelli, et al., 1987;Bo, Hagen, Kvarstein, et al.,1990;Ferguson, McKey, Bishop, et al., 1990;Dougherty, Bishop, Mooney, et al., 1993).
PMEs are indicated for women with stress incontinence and can reduce urgency and prevent urge UI (Burgio and Engel, 1990;Burgio, Robinson, and Engel, 1986;Burgio, Stutzman, and Engel, 1989;Burton, Pearce, Burgio, et al., 1988;Castleden, Duffin, Asher, et al., 1985;Klarskov, Nielsen, Kromman-Andersen, et al., 1991;McDowell, Burgio, Dombrowski, et al., 1992). They may be effective in reducing incontinence following prostatic surgery in men, but to date have only been tested for postprostatectomy in conjunction with a biofeedback component (Burgio, Stutzman, and Engel, 1989). PMEs are effective in reducing UI even after multiple surgical repairs in women (Baigis-Smith, Smith, Rose, et al., 1989;Brink, Wells, and Diokno, 1987;Burgio and Engel, 1990; Castleden, Duffin, and Mitchell, 1984; Ferguson, McKey, Bishop, et al.,1990; Heller, Whitehead, and Johnson, 1989; Henalla, Kirwan, Castleden, et al., 1988;Pearson and Droessler, 1988;Rose, Baigis-Smith, Smith, et al., 1990;Stoddart, 1983).
The effects of PME alone have been well documented in the medical literature. A summary of outcome findings from well-conducted studies follows.
Dougherty, Bishop, Mooney, et al. 1993) studied 65 women 35-75 years of age (mean age 51.3) and obtained a 62-percent reduction in UI episodes, and Ferguson, McKey, Bishop, et al. (1990) studied 20 women and demonstrated a 56- to 58-percent reduction in leakage as measured by 24-hour pad test using audiotape instruction in PME. Telephone contact and ongoing use of a bladder record may have contributed to the greater success found in these studies compared with others using a one-time instruction session.
To date, the most effective use of PME has been reported in an uncontrolled study by Benvenuti, Caputo, Bandinelli, et al. 1987), who provided 20 sessions of PME and other behavioral strategies and an intensive home program for a total of 10 contact hours to 20 women aged 35-65 years (mean age 50.8). In addition to a 95-percent reduction in incontinent episodes, significant changes were also reported FUL and MUCP at rest and during maximal voluntary contraction. A significant clinical benefit was consistent with changes in several physical measures of bladder function.
In a randomized clinical trial comparing PME and phenylpropanolamine hydrochloride (PPA), PME was found to be an effective alternative treatment for SUI comparable to PPA (Wells, Brink, Diokno, et al., 1991). Of the 54 subjects who completed the exercise program and the 64 who completed the drug protocol, 77 percent of the exercise subjects and 84 percent of the drug subjects reported improvement. The PME protocol involved 6 months of active PME taught with only written instruction, followed by monthly monitoring visits. The PPA was administered in doses of 50 mg daily for 2 weeks, increasing to twice daily if wetting continued. Adherence to the drug treatment was greater than to the exercise protocol.
Indications are that the intensity of the exercise program affects physiological and functional outcomes. Bo, Hagen, Kvarstein, et al. (1990) found that 52 subjects of mean age 45.9 years (range 24-64) randomized into a group receiving ongoing guidance in performing maximum contractions of the pelvic muscle that increased in intensity over 6 months reportedsignificantly greater reduction in incontinence and changes in physiological measures of pelvic floor strength compared with a group that received only a single session of instruction and a home exercise program. The group receiving the ongoing instruction reported a 60.1-percent cure/improvement rate compared with 17.3 percent attained in the home exercise group. This work also indicates a possible systematic relationship between symptom reduction and objective physical changes. Based on the data presented Benvenuti, Caputo, Bandinelli, et al., 1987;Elia and Bergman, 1993; Mouritsen, Frimodt, and Moller, 1991), there is evidence that pelvic muscle re-education has the potential to change muscle physiology. Standards for assessment of change in pelvic muscle function have yet to be established, however.
PME also appears to be effective in the treatment of older adults. Flynn, Cell, and Luisi (1994) provided treatment for transient UI in 37 older adults receiving home nursing care (mean age 76) and behavioral strategies that included education in the maintenance of bowel regularity, bladder and habit training, fluid intake management, and PME. An 82.4-percent decrease in UI was attained with an average of five nursing visits. Because those patients with transient UI were not separated in the final analysis, the specific effect of the behavioral treatment is difficult to determine. Nonetheless, this report and others (Scheve, Engel, McCormick, et al., 1991) demonstrate the overall effectiveness of a well-directed nursing program, which includes PME for UI in the homebound and long-term chronically ill patients.
Summary of findings.
Evidence demonstrates that patients require repeated guidance over an extended period of time to derive optimal benefit from PME. Kegel himself recommended that patients be seen weekly to ensure that the exercises were being performed correctly. Further controlled studies are needed to demonstrate the most efficient method of teaching PME, exercise prescription, and the conditions in which biofeedback provides an added benefit to PME alone. It should also be noted that the majority of the research on PME is in women only.
Pelvic muscle rehabilitation and bladder inhibition using biofeedback therapy are recommended for patients with stress UI, urge UI, and mixed UI. (Strength of Evidence = A.)
Some type of biofeedback device is often used to assist patients to gain function and pelvic muscle awareness {Burns, Pranikoff, Nochajski, et al., 1990). The aim of biofeedback therapy, which uses electronic or mechanical instruments to relay information to patients about their physiologic activity, is to improve bladder dysfunction by teaching people to change physiologic responses that mediate bladder control (Burgio and Engel, 1990). Auditory or visual display of this information forms the core of biofeedback procedures (Schwartz, 1995). Biofeedback for UI typically uses single measurement (surface, needle, vaginal, or anal probe) EMG or manometric methods. Biofeedback using multimeasurement feedback methods involves simultaneous measurement of pelvic and abdominal/detrusor muscle activity. Biofeedback should be used in conjunction with other behavioral techniques such as PME and bladder training. As with all of the behavioral techniques, successful application of biofeedback depends greatly on the knowledge and skill of the health care provider, whose knowledge must include familiarity with evaluation techniques, anatomic and physiologic correlates of the different forms and symptoms of bladder dysfunction, instrumentation, and behavioral principles that guide the procedure.
Studies on the various applications of biofeedback combined with behavioral treatment report a range of 54-87 percent improvement in incontinence across various patient groups using different biofeedback and behavioral procedures. Some biofeedback protocols use only one measure for reinforcement of pelvic muscle contraction, whereas others use up to three, and include measures of abdominal and detrusor activity. The biofeedback protocol that has been associated with the largest and most consistent symptom reduction is one that reinforces pelvic muscle contraction concurrently with inhibition of abdominal and detrusor contraction. Reports using this multimeasurement method show a 75.9-82 percent reduction in UI across six studies involving 166 subjectsBurgio, Robinson, and Engel, 1986;Burgio, Stutzman, and Engel, 1989;(Burgio, Whitehead, and Engel, 1985;Burton, Pearce, Burgio, et al., 1988;McDowell, Burgio, Dombrowski, et al., 1992). The presumed benefit of the multimeasurement procedure is that it reinforces pelvic floor contraction directly with moment-to-moment feedback, which characterizes for the patient the quality and intensity of the contraction. Without biofeedback, weak pelvic muscles may provide limited kinesthetic feedback to the desired contraction, and as a result the patient uses an attenuated internal reference to upgrade muscle contractions. Combining bladder and sphincter biofeedback also allows teaching pelvic muscle contraction in response to increasing bladder volume and observed detrusor activity.
In a controlled study, Burgio, Robinson, and Engel 1986) found that 13 subjects (mean age 47.9) receiving multimeasurement biofeedback reduced incontinence by 75.9 percent compared with a 51-percent reduction obtained in 11 subjects (mean age 40.7) who received only verbal feedback and instruction for PME with digital palpation. The multimeasurement biofeedback method has also been used successfully in the treatment of UI in postprostatectomy patients with urge and intermittent stress incontinence (Burgio, Stutzman, and Engel, 1989). However, another study demonstrated that when subjects complained primarily of urge incontinence, no benefit was obtained with the addition of biofeedback to behavioral training and PME, which was provided by a well-trained clinician over an average of five clinic sessions (Burton, Pearce, Burgio, et al., 1988). The results of this study should be interpreted with caution, however, because the groups differed in severity before treatment.
Several studies have also demonstrated significant reductions in UI associated with neurologic disease and in the frail elderly using a combination of multimeasurement biofeedback and other behavioral techniques such as bladder training (McDowell, Engberg, Weber, et al., 1994;Middaugh, Whitehead, Burgio, et al., 1989;O'Donnell and Doyle, 1991). Because multimeasurement biofeedback can provide specific reinforcement for pelvic muscle contraction that is isolated from counterproductive abdominal contraction, it is assumed that awareness of pelvic muscle contraction can be achieved more efficiently than from vaginal palpation alone.
In contrast to multimeasurement methods, the reduction in number of pad changes per 24 hours ranged from 43 to 54 percent when single-measurement biofeedback is used, when excluding a subgroup who had received only one biofeedback session (Wilson, Faragher, Butler, et al., 1987). This improvement was attained in an approximate average of 11 sessions (0.5 to 1.5 hours each). Another study (Susset, Galea, and Read, 1990) used single-channel biofeedback over six weekly clinic visits and a home trainer with which the subjects practiced daily. These subjects demonstrated an 87-percent reduction of leakage on pad test, suggesting that a home training device may provide an added benefit to clinic biofeedback visits, especially when only single-channel biofeedback is used.
In a randomized controlled study, Burns, Pranifoff, Nochajski, et al. (1993) studied 135 women (age range 55-75 years) with primary stress incontinence in three groups. One group received PME, and another group received single-measurement EMG biofeedback to perivaginal contraction for 20 minutes per week. The two treatment groups demonstrated a 54-61 percent reduction in incontinent episodes, compared with a 6-percent reduction of incontinence in the control group, but no difference between the two treatment groups was found. The improvements were maintained over a 6-month followup, and patients with moderate-to-severe symptoms showed even more improvement in the posttreatment phase. This study demonstrated that PME reduces incontinence and provided evidence that symptom severity has a role in response.
Further research is needed to determine which biofeedback protocols ensure that optimal outcomes are achieved in individual conditions and what methods provide the most valid measures of pelvic muscle function. The multimeasurement biofeedback appears to produce greater reduction in incontinence compared with PME alone or single measurement biofeedback. It is not known, however, to what degree detrusor or intra-abdominal pressure biofeedback individually contributes to the outcomes reported.
Summary of findings.
Overall, the literature indicates that PME and other behavioral strategies, with or without biofeedback, can "cure" or reduce incontinence. Maximum benefit is derived from any pelvic muscle rehabilitation and education program when ongoing reinforcement and guidance are provided. Also, the intensity of the exercise program seems to influence both functional and physiological outcomes, and multimeasurement biofeedback protocols seem to yield the greatest and most consistent reductions in UI (Bo, Hagen, Kvarstein, et al., 1990;Burgio, Robinson, and Engel, 1986;Elia and Bergman, 1993; McDowell, Burgio, Dombrowski, et al., 1992).
Vaginal weight training is recommended for SUI in premenopausal women. (Strength of Evidence = B.)
Specially designed vaginal weights for strengthening the pelvic muscles can augment PME. The patient receives a set of vaginal weights of identical shape and volume but of increasing weight (20-100 grams). As part of a structured progressive resistive exercise program, women insert the weight intravaginally, with the tapered portion resting on the superior surface of the perineal muscle and attempt to retain it by contracting the pelvic muscles up to 15 minutes. The weight is worn while the patient is ambulatory, and the exercise is done twice daily. The hypothesized mechanism of action is that the sustained contraction required to retain the weight increases the strength of the pelvic muscles, and the weight is assumed to provide heightened proprioceptive feedback to desired pelvic muscle contraction.
Available literature on this technique includes observations made in premenopausal women with SUI. Initial observations from four studies including 103 premenopausal women indicate subjective "cure" or greatly improved status of 68-80 percent after 4-6 weeks of treatment (Bridges, Denning, Olah, et al., 1988;Olah, Bridges, Denning, et al., 1990;Peattie and Plevnik, 1988;Peattie, Plevnik, and Stanton, 1988;Wilson and Borland, 1990). Objective outcome measures included reduction of urine loss on pad test, improvement in ability to hold heavier weights intravaginally, increased pelvic muscle strength (perineometer), and significant reduction in incontinence episodes. There were minimal or no adverse reactions. However, in several studies, PMEs were performed at the same time.
Although vaginal weight training may be useful in the treatment of stress incontinence, issues of applicability to other populations, particularly postmenopausal women with pelvic organ prolapse or other comorbid conditions, must be evaluated in terms of treatment protocols and long-term effects.
Pelvic floor electrical stimulation has been shown to decrease incontinence in women with SUI. (Strength of Evidence = B.)
Pelvic floor electrical stimulation may be useful for urge and mixed incontinence. (Strength of Evidence = B.)
Pelvic floor electrical stimulation (nonimplantable) produces a contraction of the levator ani, external urethral and anal sphincters, accompanied by a reflex inhibition of the detrusor; this activity depends on a preserved reflex arc through the sacral micturition center (Vodusek, Plevnik, Vrtacnik, et al., 1988). Nonimplantable pelvic floor electrical stimulation uses vaginal or anal sensors or surface electrodes (Vodusek, Plevnik, Vrtacnik, et al., 1988). Adverse reactions are minimal and include pain and discomfort. Studies vary regarding the type and placement of electrodes; frequency, duration, and amplitude of voltage; and whether the stimulation was phasic, intermittent, or continuous. Several of these studies address long-term followup with reports that the effects for cured or improved patients ranged from 54 to 77 percent Bent, Sand, Ostergard, et al., 1993; Bergmann and Eriksen, 1986;Blowman, Pickles, Emery, et al., 1991;Caputo, Bensen, McClellan, et al., 1993;Eriksen, 1990;Eriksen, Bergmann, and Mjolnerod, 1987;Eriksen, Bergmann, and Eik-Nes, 1989;Esa, Kiwamoto, Sugiyama, et al., 1991;Fall, Ahlstrom, Carlsson, et al., 1986;Fossberg, Sorensen, Ruutu, et al., 1990;Green and Laycock, 1990; Hahn, Sommar, and Fall, 1991;Lamhut, Jackson, and Wall, 1992;Leach and Bavendam, 1989;Lose, Andersen, and Kristensen, 1986;McIntosh, Frahm, Mallett, et al., 1993;Meyer, Dhenin, Schmidt, et al., 1992;Eriksen and Mjolnerod, 1987;Nakamura, Sakurai, Tsujimoto, et al., 1986;Nakamura, Sakurai, Sugao, et al., 1987;Ohlsson, Fall, and Frankenberg-Sommar, 1989;Plevnik, Joney, Vrtacnik, et al., 1986;Sand, Richardson, Staskin, et al., 1995;Wilson, 1990; Zollner-Nielsen and Samuelsson, 1992).
Two randomized controlled trials have been conducted. Using active and placebo perianal surface patch neurostimulation for SUI in patients, Blowman, Pickles, Emergy, et al. 1991) reported a "cure" or improvement rate of 86 percent in the active group (N=7) and 33 percent in the placebo group (N=6). Electrical stimulation was not used as a single therapy, however; both groups also received instruction in PME. Using active and inactive vaginal plug devices in 52 women with SUI, Sand, Richardson, Staskin, et al. (1995) reported objective "cure" or improvement in 48 percent of the active device group and in 13 percent of the placebo group. Active device patients had significant improvements in UI episodes, leakage volume, and vaginal muscle strength and in subjective improvement measures when compared with the placebo group.
In other studies with similar settings, anal or vaginal plug devices were used for maximal electrical stimulation for 4 weeks to 3.5 months, 20 minutes to 20 hours/day. "Cure" or improvement rates ranged from 48 to 94 percent in 842 patients with stress, urge, or mixed incontinence. The effects of therapy were sustained 6 weeks to 2 years in 54-77 percent of patients, especially if patients continued to do PME after treatment (Bergman and Eriksen, 1986; Blowman, Pickles, Emery, et al., 1991;Bridges, Denning, Olah, et al., 1988;Caputo, Bensen, McClellan, et al., 1993;Eriksen, Bergmann, and Eik-Nes, 1989;Eriksen, Bergmann, and Mjolnerod, 1987;Eriksen and Eik-Nes, 1989;Esa, Kiwamoto, Sugiyama, et al., 1991;Fossberg, Sorensen, Ruutu, et al., 1990;Kunkle, Payne, and Whitmore, 1993;Meyer, Dhenin, Schmidt, et al., 1992;Plevnik, Joney, Vrtacnik, et al., 1986;Sand, Richardson, Staskin, et al., 1995;Zollner-Nielsen and Samuelsson, 1992). One study of cognitively impaired patients in a nursing home showed no significant effect of stimulation, with a trend toward increased wetness (Lamhut, Jackson, and Wall, 1992).
Summary of findings.
Research indicates that pelvic floor electrical stimulation can significantly reduce UI in women with SUI, and may be effective in men and women with mixed and urge UI. Stimulation may be effective when augmented with other pelvic muscle rehabilitation therapies. Minimal adverse side effects occur with this treatment. Treatment using stimulation requires monitoring by a health care provider to determine effectiveness. Further research is needed to determine the efficacy of pelvic floor stimulation used alone or in combination with other therapies. Standardization of the parameters of the techniques used, such as that proposed by the International Continence Society, is necessary to allow further comparison of study results.