The researchers performed a multi-center, randomized trial of 208 patients with post-prostatectomy incontinence to behavioral therapy with pelvic floor muscle exercises, bladder control techniques, and fluid management - with or without biofeedback and pelvic floor electrical stimulation with a delayed-treatment control condition between 2003 and 2009.
Study exclusion criteria included preoperative incontinence, fewer than 2 incontinence episodes per week, current active CaP treatment other than hormonal therapy, post-void residual volume greater than 200ml, prior behavioral therapy, interventional therapy for the incontinence, cardiac pacemaker, mini-mental state examination score <24, unstable medical conditions or inability to maintain a bladder diary. Patients were randomized by type and severity of incontinence. The primary outcome measured was percent reduction in number of incontinence episodes at 8 weeks as measured with a 7-day bladder diary. Other measures of voiding function were also assessed. The behavioral therapy was given in 4 visits, 2 weeks apart. Home exercises were done 3 times daily with15 repetitions. Diaries were reviewed on subsequent visits and bladder control strategies given. Educational instructions were given at each visit to improve outcomes. The group with biofeedback and electrical stimulation also had in-office, dual channel biofeedback and daily home pelvic floor electrical stimulation.
Eighty-five percent of eligible randomized patients completed 8 weeks of treatment. There were no group differences in attrition. At 8 weeks, the behavioral therapy group had a mean reduction of 55%, significantly greater than the control group (mean 24% reduction). The group who also received biofeedback and electrical stimulation did not improve compared with the behavioral therapy group alone. The improvements in the active treatment groups were sustained for the 12-month follow-up period. Complete continence was achieved in 15.7%, 17.1%, and 5.9% of the behavioral group, behavioral plus biofeedback and stimulation group and control group, respectively. Participants in both active treatment groups described their leakage as better or much better after therapy compared with only 10% in the control group. Pad usage was significantly down in both active treatment groups.
Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK
JAMA. 2011 Jan 12;305(2):151-