Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial.

CONTEXT Previous research on urge urinary incontinence has demonstrated that multicomponent behavioral training with biofeedback is safe and effective, yet it has not been established whether biofeedback is an essential component that heightens therapeutic efficacy. OBJECTIVE To examine the role of biofeedback in a multicomponent behavioral training program for urge incontinence in community-dwelling older women. DESIGN Prospective, randomized controlled trial conducted from April 1, 1995, to March 30, 2001. SETTING University-based outpatient continence clinic in the United States. PATIENTS A volunteer sample of 222 ambulatory, nondemented, community-dwelling women aged 55 to 92 years with urge incontinence or mixed incontinence with urge as the predominant pattern. Patients were stratified by race, type of incontinence (urge only vs mixed), and severity (frequency of accidents). INTERVENTIONS Patients were randomly assigned to receive 8 weeks (4 visits) of biofeedback-assisted behavioral training (n = 73), 8 weeks (4 visits) of behavioral training without biofeedback (verbal feedback based on vaginal palpation; n = 74), or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition; n = 75). MAIN OUTCOME MEASURES Reduction in the number of incontinence episodes as documented in bladder diaries, patients' perceptions and satisfaction, and changes in quality of life. RESULTS Intention-to-treat analysis showed that behavioral training with biofeedback yielded a mean 63.1% reduction (SD, 42.7%) in incontinence, verbal feedback a mean 69.4% reduction (SD, 32.7%), and the self-help booklet a mean 58.6% reduction (SD, 38.8%). The 3 groups were not significantly different from each other (P =.23). The groups differed significantly regarding patient satisfaction: 75.0% of the biofeedback group, 85.5% of the verbal feedback group, and 55.7% of the self-help booklet group reported being completely satisfied with treatment (P =.001). Significant improvements were seen across all 3 groups on 3 quality-of-life instruments, with no significant between-group differences. CONCLUSIONS Biofeedback to teach pelvic floor muscle control, verbal feedback based on vaginal palpation, and a self-help booklet in a first-line behavioral training program all achieved comparable improvements in urge incontinence in community-dwelling older women. Patients' perceptions of treatment were significantly better for the 2 behavioral training interventions.