Post-prostatectomy incontinence (PPI) has significant medical, psychological and social consequences. Although severe incontinence is temporary for most men after prostatectomy, persistent stress incontinence and detrusor instability are not uncommon. Conservative treatments for PPI include behavioral training (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, fluid management, and bladder control techniques to control urgency and stress-induced leakage) with and without biofeedback (BF) and pelvic muscle electrical stimulation (ES). These treatments have demonstrated efficacy in small clinical series; however, randomized, controlled trials of behavioral treatments for PPI are lacking. Also the role of technologies (BF and ES) in behavioral training for PPI remains to be discerned.
Specific Aim 1 is to test the effectiveness of behavioral treatment with and without the use of BF and ES technology. This project is a prospective, randomized, controlled, 3-arm trial in which 204 men, at least one- year post-prostatectomy, will be stratified by type and severity of incontinence. Subjects will be randomized to 8 weeks of (1) behavioral training with BF and ES, (2) behavioral training without technologies, or (3) no treatment. Bladder diaries, 24-hour pad tests, and quality of life (QoL) instruments completed by subjects prior to randomization and following the last treatment session will be used to calculate reduction of the frequency and volume of incontinence and impact on QoL. Because long-term outcome data for conservative treatments of PPI are absent from the literature, outcome data will also be obtained at 6 and 12 months.
Specific Aim 2 is to examine the cost-effectiveness of both conservative treatments using the most widely adopted method for the economic evaluation of health interventions, cost-effectiveness analysis (CEA). Cost data are essential to assist third party payors and clinicians in selection of appropriate, cost-effective therapy for PPI.
Specific Aim 3 is to characterize subjects on pre-treatment variables with potential predictive value to explore useful selection criteria for behavioral treatments with and without technology, data essential for development of clinical pathways.
|Goode, Patricia S; Burgio, Kathryn L; Johnson 2nd, Theodore M et al. (2011) Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA 305:151-9|