Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 56 participants or records.
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