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.