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Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial
Goode PS, Burgio KL, Locher JL, Roth DL, Umlauf MG, Richter HE, Varner RE, Lloyd LK
JAMA 2003 Jul 16;290(3):345-352
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

CONTEXT: Pelvic floor electrical stimulation (PFES) has been shown to be effective for stress incontinence. However, its role in a multicomponent behavioral training program has not been defined. OBJECTIVE: To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence. DESIGN AND SETTING: Prospective randomized controlled trial conducted from October 1, 1995, through May 1, 2001, at a university-based outpatient continence clinic in the United States. PATIENTS: Volunteer sample of 200 ambulatory, nondemented, community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern; stratified by race, type of incontinence (stress only versus mixed), and severity (frequency of episodes). INTERVENTIONS: Patients were randomly assigned to 8 weeks (4 visits) of behavioral training, 8 weeks (4 visits) of the behavioral training plus home PFES, or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition). MAIN OUTCOME MEASURES: Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries. Secondary outcomes were patient satisfaction and changes in quality of life. RESULTS: Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6% with behavioral training, 71.9% with behavioral training plus PFES, and 52.5% with the self-help booklet (p = 0.005). In comparison with the self-help booklet, behavioral training (p = 0.02) and behavioral training plus PFES (p = 0.002) were significantly more effective, but they were not significantly different from each other (p = 0.60). The PFES group had significantly better patient self-perception of outcome (p < 0.001) and satisfaction with progress (p = 0.02). Significant improvements were seen across all 3 groups on the Incontinence Impact Questionnaire but with no between-group differences. CONCLUSIONS: Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence. A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs.

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