Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy.

PURPOSE We evaluated electrical stimulation combined with pelvic floor muscle training for urinary incontinence after radical prostatectomy in a randomized controlled study. MATERIALS AND METHODS A total of 56 men with severe urinary incontinence (more than 200 gm daily), mean ± SD age 66.6 ± 6.2 years, were randomized to an active treatment group (26) or a sham group (30). All patients performed pelvic floor muscle training preoperatively and continued throughout the study. For active stimulation 50 Hz square waves of 300 μs pulse duration and a 5 seconds on, 5 seconds off duty cycle were applied for 15 minutes twice daily with an anal electrode. Sham stimulation was limited to 3 mA with a 2 seconds on, 13 seconds off duty cycle. RESULTS In the active group 8 (36%), 14 (63%), 18 (81%) and 19 (86%) patients were continent (22) vs 1 (4%), 4 (16%), 11 (44%) and 17 (86%) in the sham group (25) (leakage less than 8 gm daily) after 1, 3, 6 and 12 months, respectively. There was a significant difference in the number of continent patients between the groups at 1, 3 and 6 months (p = 0.0161, p = 0.0021 and p = 0.0156, respectively). The time to achieve continence was significantly shorter in the active group (2.71 ± 2.6 months) than in the sham group (6.82 ± 3.9 months, p = 0.0006). Changes in the amount of leakage, the International Consultation on Incontinence Questionnaire-Short Form score and the King's Health Questionnaire score were significantly larger in the active group at 1 month but there was no difference at 12 months. CONCLUSIONS Electrical stimulation resulted in earlier recovery of continence in patients with urinary incontinence after radical prostatectomy.