Effect of Behavioral Training with or Without Pelvic Floor Electrical Stimulation on Stress Incontinence in Women: A Randomized Controlled Trial

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 vs 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=.005). In comparison with the self-help booklet, behavioral training (P=.02) and behavioral training plus PFES (P=.002) were significantly more effective, but they were not significantly different from each other (P=.60). The PFES group had significantly better patient self-perception of outcome (P<.001) and satisfaction with progress (P=.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.