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ORIGINAL RESEARCH |
From the Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Medical Center; and the School of Medicine, Center for Aging, and School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.
Address reprint requests to: Kathryn L. Burgio, PhD, Birmingham VA Medical Center, GRECC/11G, 700 19th Street South, Birmingham, AL 35233; E-mail: kburgio{at}aging.uab.edu.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: This report is a secondary analysis of data from three prospective, randomized, clinical trials testing behavioral interventions for urinary incontinence. Participants were a volunteer sample of 258 ambulatory, nondemented, community-dwelling women, aged 40–92 years, with stress, urge, or mixed urinary incontinence. Participants received 8 weeks (four visits) of multicomponent behavioral training in each study. The relationship between a number of variables and treatment success were explored by univariate and multivariable logistic regression analyses.
RESULTS: Successful treatment of predominantly urge incontinence (75% reduction of incontinent episodes as recorded on bladder diary) was associated with not wearing any form of protection for incontinence (P = .045; 95% confidence interval [CI] .282, .987). Achieving total continence (100% reduction) was associated with fewer incontinent episodes at baseline (P < .001; 95% CI .138, .557), previous surgery for incontinence (P = .021; 95% CI 1.169, 6.543), and lower education level (P = .022; 95% CI .175, .871). Successful treatment of predominantly stress incontinence (75% reduction) was related to not having previous evaluation or treatment for incontinence (P = .001; 95% CI .026, .415), and fewer incontinent episodes on baseline bladder diary (P =.026; 95% CI .210, .907). Outcomes were not associated with age, race, type of incontinence, or a number of other variables reflecting medical history, obstetric history, medications, pelvic examination, body mass index, urodynamic parameters, or psychological distress.
CONCLUSION: Aside from indicators of severity and previous treatment, there were few associations between baseline clinical variables and outcome of behavioral treatment.
Urinary incontinence is a common condition that affects millions of people, including young, middle-aged, and older adults.1,2 Among older adults, incontinence is also an expensive condition that has been estimated to cost $26.3 billion annually in the United States, or $3565 per individual with symptoms.3 Among the many treatment options for incontinence are behavioral interventions, including bladder training, prompted voiding, pelvic floor muscle training and exercise, biofeedback, and multicomponent training that includes elements from each of these. Several studies have shown that behavioral treatment is effective for both urge and stress incontinence in women of all ages and in a variety of subpopulations.4–29 Behavioral treatments have been recognized for their efficacy by the 1988 Consensus Conference on Urinary Incontinence in Adults and recommended as a first-line therapy by the 1996 Guideline for Urinary Incontinence developed by the Agency for Health Care Policy and Research.30,31
Behavioral training is a type of behavioral treatment, in which biofeedback or verbal feedback is used to teach patients how to control the physiologic responses of the bladder and pelvic floor muscles that mediate continence.10–16,24,27 Studies show clearly that biofeedback-assisted behavioral training is an effective and acceptable conservative treatment for stress or urge incontinence, producing mean reductions of incontinence ranging from 60% to 85%. It is at least as effective as drug therapy for urge incontinence, and in one randomized clinical trial it was more effective than immediate-release oxybutynin chloride.24
Although there are many studies that report the effects of behavioral treatment in a variety of populations, few report on factors that might influence or predict the outcome of therapy. Most patients who are motivated and cooperative with behavioral treatment experience some degree of improvement. However, there is wide variation in outcome, and little is known of the characteristics of patients who respond best to behavioral therapy.
Most previous studies have found that improvements are unrelated to type of incontinence or urodynamic diagnosis.17,22,25,29 The literature provides some evidence that patients with more severe urine loss had greater reductions of incontinence after behavioral treatment.17,26 However, other studies have shown that patients with more severe incontinence have poorer outcomes,14,20 or no relationship between severity and outcome.18,25,29,32 Some investigations have reported that younger patients have better outcomes,10,26,28 whereas others show no relationship to age.10,14,17,18,32 Thus, the literature on predictors is inconsistent, and many studies have small sample sizes.
The purpose of the present study was to identify predictors of outcome of a multicomponent behavioral training program for urge and stress incontinence in community-dwelling women. Data from three randomized clinical trials were used to characterize patients on a number of variables with potential influence on treatment outcome. The relationships between these variables and treatment outcomes were analyzed by logistic regression modeling.
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MATERIALS AND METHODS |
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. The first trial was a controlled study of behavioral versus drug treatment for urge incontinence in older women.24 The 63 women who received biofeedback-assisted behavioral training were included in the present analysis.
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The third trial was a study of behavioral training with biofeedback, with or without electrical stimulation, for predominantly stress incontinence in women.34 It was run concurrently with the second trial with the same site, clinical staff, measurement instruments, and schedule of clinic visits. Sixty women who received behavioral training with biofeedback (no electrical stimulation) were included in this analysis.
Participants in all three studies were recruited from the community through outreach, advertisement, and professional referrals and then screened by telephone for eligibility. To be eligible, patients had to describe urinary incontinence occurring at least twice per week and persisting for at least 3 months. All participants gave informed consent according to procedures approved by the University Institutional Review Board for Human Use.
Potential subjects who met initial screening criteria were evaluated by history, physical examination, postvoid catheterization for residual urine, urodynamic evaluation, and urinalysis. In addition, the Mini-Mental State Examination was used to screen for dementia.35 Urodynamic testing (two-channel supine water cystometry with provocation) was performed to demonstrate bladder or sphincter dysfunction (for inclusion) and to classify the type of incontinence. A performance-based mobility assessment measured time required for patients to walk 15 feet to the toilet and position to void.
To measure pretreatment frequency of incontinence, patients were provided with 2 weeks worth of bladder diary booklets.36 Patients used these diaries to document the time of every void and incontinent episode and the circumstances of each episode. During this time, participants also completed the Hopkins Symptom Checklist37 to measure psychological distress.
To be included in these studies, patients had to have an average of at least two incontinent episodes per week on the bladder diary. In the first two studies, urge incontinence had to be the predominant pattern (the number of urge incontinent episodes exceeded the number of stress and other incontinent episodes). In the third, stress incontinence had to be the predominant pattern. There also had to be urodynamic evidence of bladder dysfunction in the first two studies (detrusor instability during filling or provocation or reduced maximal cystometric capacity) or urethral insufficiency in the third study (positive home pad test or clinic stress test). Patients were excluded if they had continual leakage, elevated postvoid residual urine volume, uterine prolapse past the vaginal introitus, decompensated congestive heart failure, or impaired mental status (Mini-Mental State Examination score less than 24).
Inclusion and exclusion criteria were the same for the first two studies, with three exceptions. The first trial had exclusion criteria related to the use of anticholinergic medication in the drug group (eg, narrow angle glaucoma), a lower threshold for the definition of reduced maximum cystometric capacity (350 mL versus 400 mL), and a higher threshold for definition of elevated postvoid residual urine volume (200 mL versus 150 mL). The third trial had a lower age cut-off than the first two trials (40 years compared with 55 years). It also selected for stress predominant incontinence and had exclusion criteria related to the use of electrical stimulation (pregnancy, pacemaker).
In all three studies, patients were stratified by race, severity, and type of incontinence and randomized within strata. Blocked randomization was used to assure similar group sizes.
For all patients, treatment was implemented in four clinic visits at 2-week intervals over an 8-week period. Patients completed a daily bladder diary throughout treatment. At each visit, clinic staff reviewed bladder diaries to ensure that entries were clear and interpretable. Interventions were implemented by nurse practitioners. During clinic visits, patients were taught skills and strategies for preventing incontinence and provided with verbal and written instructions for daily home practice.
The details of intervention have previously been described in detail.24,33,38 In visit 1, patients learned selective contraction of pelvic floor muscles. In visit 2, they were taught how to use pelvic floor muscle contractions to suppress urgency and prevent urge incontinence ("urge strategies") and stress incontinence ("stress strategies"), as appropriate.36 In visit 3, patients who had not achieved at least 50% improvement repeated pelvic floor muscle training. Visit 4 was used to review progress, "fine-tune" home practice, and encourage persistence. Instructions for pelvic floor muscle exercises included 45 exercises every day, divided into manageable sessions (usually three sets of 15 exercises each) and active use of pelvic floor muscles to suppress urgency and prevent stress or urge incontinence. Duration of contractions was increased gradually over the treatment period up to 10 seconds. Patients used bladder diaries and exercise records to self-monitor incontinence and daily exercise.
After the last treatment visit, patients completed 2 weeks of posttreatment bladder diaries, which were collected when they returned for their posttreatment visit.
Because the mechanisms of stress and urge incontinence are different, the mechanisms of therapeutic improvement and factors affecting improvement might be different as well. For this reason, the data on treatment of urge predominant incontinence and stress predominant incontinence were analyzed separately. The three subgroups of patients with urge-predominant incontinence were first compared by 
2 analysis and analysis of variance, to determine whether there were any significant differences on key variables before the data were combined.
Several potential predictors of outcome were selected for analysis, including demographic characteristics (age, race, education), type of incontinence (stress, urge, mixed, incontinent episodes with no sensation), frequency of incontinent episodes per week on diary and self-report, self-reported volume of incontinent episodes, duration, use of protection, previous evaluation and treatment (with medication, surgery), frequency of daytime and nighttime urination (on diary and self-report), impact of incontinence (activity restriction, how disturbing to the patient), medical history variables (arthritis, bladder infections, constipation, age at menopause, duration of menopause, hysterectomy, use of alcohol), medications (ie, diuretics, sedatives, estrogens), obstetric history (parity, number of vaginal, cesarean, and forceps deliveries, birth weight of heaviest infant), body mass index, pelvic examination (atrophic mucosa, vaginitis, urethrocele, cystocele), rectal examination (internal anal sphincter tone, external anal sphincter strength), urodynamic parameters (volume voided, postvoid residual urine volume, first desire to void, strong desire to void, bladder capacity, detrusor instability, stress provocation, urge provocation), mental status screening (Mini-Mental State Examination), psychological distress (Hopkins Symptom Checklist), self-efficacy (confidence that will improve in the treatment program), and mobility (performance-based mobility assessment). Some variables could not be included because there were too few cases to permit a valid analysis (congestive heart failure, chronic obstructive pulmonary disease, diabetes mellitus, history of stroke, Parkinson’s disease, uterine prolapse, rectocele, fecal impaction, current smoking, and antispasmodic medications).
Statistical analyses were conducted with SPSS 10 for Windows (SPSS, Chicago, IL). Univariate analyses were used to test the relationship between each potential predictor and outcome of behavioral treatment using logistic regression analyses. Variables with a relationship to outcome on univariate analysis (P < .15) were then entered into a multivariable logistic regression model.
Treatment outcome was defined as a success or failure based on reduction in the frequency of incontinence as recorded in the bladder diaries. The pretreatment and posttreatment frequencies of incontinence were used to calculate a percent reduction for each patient ([pretreatment frequency minus posttreatment frequency] / [pretreatment frequency] x 100%).11,18 For the purpose of this analysis, successful outcomes were defined in two ways. First, a reduction of 75% or more in the frequency of incontinent episodes was defined as a success, whereas any value less than 75% was considered a failure. Then a second model was developed to predict total continence as the outcome, defined as 100% reduction of incontinent episodes.
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RESULTS |
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In the univariate analyses, one variable, wearing protection, was significantly related to 75% reduction of urge incontinence. Women who reported that they wore some form of protection for incontinence were significantly less likely to have a successful outcome than were women who were not wearing any form of protection (P = .005). Other factors included in the multivariable logistic regression analysis (P < .15) were self-reported frequency of incontinent episodes (P = .063), arthritis (P = .079), and bladder capacity (P = .137). In the multivariable model, not wearing any form of protection was the only factor significantly associated with 75% reduction in incontinent episodes (P = .045; Table 3).
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In the multivariable regression model, lower frequency of incontinent episodes (P < .001), previous surgery for incontinence (P =.021), and lower education level (P = .022) were independent predictors of a successful treatment outcome (Table 4). Not wearing protection was marginally significant (P = .057).
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In univariate analysis, three variables were significantly related to 75% reduction of incontinence: any previous evaluation or treatment for incontinence (P = .001), previous medication for incontinence (P = .006), and previous bladder surgery for incontinence (P = .039). Only previous evaluation or treatment was included in the multivariable analysis, owing to multicollinearity. Also included in the multivariable analysis was self-reported frequency of incontinent episodes (P = .055). It was necessary to restrict this analysis to two predictors because only 22 patients were in the less-than-75%-improved category.
In the multivariable regression model, both variables–previous evaluation or treatment for incontinence (P = .001) and frequency of incontinent episodes (P = .026)–were significantly related to outcome. Women who had previously received an evaluation or treatment for incontinence and those who had more than ten incontinent episodes per week on bladder diary were less likely to have a successful outcome of behavioral treatment (Table 5). Subsequent analyses suggested that previous treatment with medication (P = .020) was more important than previous surgery (P = .182) in predicting outcome, after taking frequency of incontinent episodes into account.
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DISCUSSION |
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Although frequency of incontinent episodes was only marginally related to 75% reduction of incontinence (P = .073), it seems to be a strong predictor of achieving total continence. Previous research has shown that the frequency of incontinent episodes before treatment is highly correlated with frequency of incontinent episodes posttreatment.14 The patient who has the fewest incontinent episodes at baseline will have the fewest incontinent episodes after treatment. Likewise, this study demonstrates that those with the fewest incontinent episodes on a baseline bladder diary are most likely to eliminate incontinence completely with behavioral treatment.
Not wearing protection was the strongest predictor of 75% improvement in urge incontinence and was marginally significant for total continence. Most likely, wearing protection is a reflection of the severity of incontinence, which might not be captured adequately by separate measures of incontinence frequency or volume alone. It is possible that frequency and volume of incontinence interact with the patient’s level of tolerance for wetness to determine whether and what form of protection she will wear, and that this composite is a better predictor of outcome than a single aspect of severity.
The association between previous surgery for incontinence and achieving total continence might be related to a beneficial effect of surgery on the bladder outlet. The behavioral treatment used in these studies focused on strengthening the outlet and used pelvic floor muscle contraction to occlude the urethra and inhibit detrusor contractions. Women who had a prior repair might have had some extra measure of pelvic floor support that helped them benefit from this training. Another possibility is that postoperative detrusor overactivity might be especially responsive to behavioral treatment.
The relationship between successful outcome and having a lower education level was unexpected. A possible explanation is that women with less education relied more on the provider’s judgment and therefore were more compliant with instructions than were women with more education.
For stress incontinence, two variables—previous evaluation or treatment for incontinence and higher frequency of incontinent episodes—were related to less successful outcome. Although outcome did not differ according to type of incontinence as documented on bladder diary (stress only versus mixed), the association with previous medication for incontinence would seem to indicate that having urge incontinence severe enough to have previously been prescribed a medication might be a detriment to successful treatment.
Most of the variables selected for exploration as predictors were not significantly related to outcome. For example, parity, which is a clear risk factor for incontinence, was unrelated to outcome of therapy. Participants with 2° or 3° cystocele did as well in behavioral treatment as those without a cystocele. Diuretics did not adversely affect response to treatment, nor did a lower education level. Treatment outcome was unaffected by history of hysterectomy, hormone therapy, body mass index, or urodynamic parameters. Although there were too few cases for a valid statistical analysis, it is interesting that all five participants with uterine prolapse had successful outcomes.
One limitation of this study is that age had to be explored within a restricted range. Within the limited age range, however, there was no indication that reduction of incontinence was related in any way to the patient’s age, as reported previously.10,14,17,18,32 Thus a patient’s age should not be a barrier to her ability to respond to behavioral treatment. Even Kegel in his 1951 treatise reported, "Some of the most gratifying results were obtained in the eighth decade of life" (p. 917).4 Similarly, the analysis did not include a full range of mental status scores, because patients with significant cognitive impairment were excluded, and the study was limited in its ability to evaluate the role of mobility because all participants were ambulatory.
Aside from stress provocation, this study did not include measures of urethral insufficiency, such as Valsalva leak point pressure or urethral closure pressure. It is possible that had these measurements been obtained, they might have been predictive of outcome. Perhaps in future studies a more careful assessment of urodynamic factors, as well as muscle strength and patients’ motivation to adhere to the behavioral program, would shed light on the characteristics of women most likely to benefit from behavioral treatment.
Overall, the results indicate that response to treatment cannot be predicted from the type of incontinence, the patient’s medical or obstetric history, the results of her pelvic or rectal examination, nor the findings on her urodynamic testing. Aside from the frequency of incontinence, wearing protection, and previous treatment, there is little information in the usual evaluation of a patient with stress or urge incontinence that would indicate the likelihood of her success with behavioral treatment, whether it is a significant reduction of incontinence or total elimination of incontinent episodes. Thus, given the facts that most motivated patients receive some benefit from behavioral treatment and that it involves minimal risk or discomfort, there is no reason to discourage any woman with stress or urge incontinence who is motivated to exert the effort necessary to participate in behavioral treatment.
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Footnotes |
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The authors thank David T. Redden, PhD, for biostatistical consultation.
doi:10.1016/S0029-7844(03)00770-1
Received April 22, 2003. Received in revised form June 18, 2003. Accepted June 26, 2003.
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REFERENCES |
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| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
