Behavioral Therapy With or Without Biofeedback and Pelvic Floor Electrical Stimulation for Persistent Postprostatectomy Incontinence A Randomized Controlled Trial

• Type of Material: Article
• Authors: Patricia S. Goode, University of Alabama Birmingham; Kathryn L. Burgio, University of Alabama Birmingham; Theodore Johnson II, Emory University; Olivio J. Clay, University of Alabama Birmingham; David L. Roth, University of Alabama Birmingham; Alayne D. Markland, University of Alabama Birmingham; Jeffrey H. Burkhardt, University of Alabama Birmingham; Muta Issa, Emory University; L. Keith Lloyd, University of Alabama Birmingham
• Language: English
• Date: 2011-01-12
• Publisher: American Medical Association
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 American Medical Association. All Rights Reserved.
• Final Published Version (URL): http://dx.doi.org/10.1001/jama.2010.1972
• Title of Journal or Parent Work: JAMA-Journal of the American Medical Association
• Volume: 305
• Issue: 2
• Start Page: 151
• End Page: 159
• Grant/Funding Information: This study was supported by grant R01 DK60044 from the National Institute of Diabetes and Digestive and Kidney Diseases and by the Department of Veterans Affairs Birmingham–Atlanta Geriatric Research, Education, and Clinical Center.
• Keywords: General & Internal Medicine; EXERCISES; ASSOCIATION SYMPTOM INDEX; OUTCOMES; VALIDATION; MEDICINE, GENERAL & INTERNAL; CANCER; Medicine, General & Internal; WOMEN; URINARY-INCONTINENCE; Science & Technology; Life Sciences & Biomedicine; QUALITY-OF-LIFE; RADICAL PROSTATECTOMY; BENIGN PROSTATIC HYPERPLASIA
• Research Categories: Health Sciences, Medicine and Surgery; Biology, Biostatistics

Abstract

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 ©2011 American Medical Association. All rights reserved.