Full title: Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial.
CONTEXT: Although behavioral therapy has been shown to improve postoperative recovery of continence, there have been no controlled trials of behavioral therapy for postprostatectomy incontinence persisting more than 1 year.
OBJECTIVE: To evaluate the effectiveness of behavioral therapy for reducing persistent postprostatectomy incontinence and to determine whether the technologies of biofeedback and pelvic floor electrical stimulation enhance the effectiveness of behavioral therapy.
DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized controlled trial involving 208 community-dwelling men aged 51 through 84 years with incontinence persisting 1 to 17 years after radical prostatectomy was conducted at a university and 2 Veterans Affairs continence clinics (2003-2008) and included a 1-year follow-up after active treatment. Twenty-four percent of the men were African American; 75%, white.
INTERVENTIONS: After stratification by type and frequency of incontinence, participants were randomized to 1 of 3 groups: 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control strategies); behavioral therapy plus in-office, dual-channel electromyograph biofeedback and daily home pelvic floor electrical stimulation at 20 Hz, current up to 100 mA (behavior plus); or delayed treatment, which served as the control group.
MAIN OUTCOME MEASURE: Percentage reduction in mean number of incontinence episodes after 8 weeks of treatment as documented in 7-day bladder diaries. RESULTS: Mean incontinence episodes decreased from 28 to 13 per week (55% reduction; 95% confidence interval [CI], 44%-66%) after behavioral therapy and from 26 to 12 (51% reduction; 95% CI, 37%-65%) after behavior plus therapy. Both reductions were significantly greater than the reduction from 25 to 21 (24% reduction; 95% CI, 10%-39%) observed among controls (P = .001 for both treatment groups). However, there was no significant difference in incontinence reduction between the treatment groups (P = .69). Improvements were durable to 12 months in the active treatment groups: 50% reduction (95% CI, 39.8%-61.1%; 13.5 episodes per week) in the behavioral group and 59% reduction (95% CI, 45.0%-73.1%; 9.1 episodes per week) in the behavior plus group (P = .32).
CONCLUSIONS: Among patients with postprostatectomy incontinence for at least 1 year, 8 weeks of behavioral therapy, compared with a delayed-treatment control, resulted in fewer incontinence episodes. The addition of biofeedback and pelvic floor electrical stimulation did not result in greater effectiveness.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00212264.
JAMA. 2011 Jan 12;305(2):151-9. Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Department of Veterans Affairs, Birmingham–Atlanta Geriatric Research, Education, and Clinical Center, Atlanta, Georgia, USA. email@example.com