Efficacy of perineal electrical stimulation in men with urinary incontinence after radical prostatectomy. A prospective randomized controlled trial

Abstract

Objective To evaluate the efficacy of perineal electrical stimulation (ES) on anxiety, depression, incontinence-related quality of life (QoL), and clinical parameters in men with urinary incontinence (UI) after radical prostatectomy (RP). Methods Fifty-eight men with UI after RP were randomized into two groups using the random numbers generator as follows: Group 1 received perineal ES (n:29), and Group 2 no treatment (n:29). Perineal ES was performed in lithotomy position via a stimulation device (Enraf Myomed 632) with surface electrodes, 3 days a week, 20 min a day, for a total of 24 sessions for 8 weeks. Men were evaluated in terms of continence rates (primary outcome), incontinence severity (24 h-pad test), incontinence episodes (3-day bladder diary), anxiety-depression (HADS), QoL (IIQ-7), and improvement rates and treatment satisfaction (Likert scale) at the baseline and the end of treatment (8th week). Results A statistically significant improvement was found in all parameters except depression in Group 1, in the severity of incontinence and QoL parameters in Group 2 at the 8th week compared to the baseline values (p < 0.05). At the end of treatment; the severity of incontinence, incontinence episodes, QoL, and anxiety were significantly improved in Group 1 compared to Group 2 (p < 0.05). No difference was found between the two groups in terms of depression (p > 0.05). The continence and improvement rates and treatment satisfaction were significantly higher in Group 1 than in Group 2 (p < 0.05). Conclusion Perineal ES is more effective than no treatment in men with UI after RP as an alternative ES option that is well tolerated and does not produce serious adverse events. Clinical Trial Registration: This study was registered with number, NCT05236140.