Efficacy of Magnetic Stimulation in Men With Urinary Incontinence After Radical Prostatectomy: a Randomized, Quadruple-Blind, Sham-Controlled Clinical Trial

Abstract

Objective: To evaluate the efficacy of MStim on incontinence-related clinical parameters, quality of life (QoL), sexual function, depression and anxiety in patients with UI after RP. Methods: Forty men with UI after RP were randomized into two groups using the random numbers generator as follows: Group 1 received MStim (n: 20), and Group 2 Sham-MStim (control) (n: 20). MStim and Sham-Mstim were performed with MStim therapy armchair (Novamag NT60), 2 days a week, 20 min a day, a total of 16 sessions for 8 weeks. Men were evaluated in terms of improvement rates (primary outcome), severity of incontinence (24 h-pad test), frequency of voiding, nocturia, incontinence episodes, number of pads, (3-day bladder diary) anxiety-depression (HADS), QoL (IIQ-7), sexual function (IIEF), and continence rates and treatment satisfaction. Results: While there was a statistically significant improvement in all parameters except erectile function, sexual desire, and intercourse satisfaction and overall satisfaction subgroups of sexual function and depression Group 1, a statistically significant improvement was found only in the severity of incontinence and bladder diary 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, nocturia, incontinence episodes, QoL, total and orgasmic function subgroups of sexual function and anxiety were significantly improved in Group 1 compared to Group 2 at the 8th week (p < 0.05). The improvement rates (75.0% vs. 26.3%), continence rates (45.0% vs. 15.8%), and treatment satisfaction (effect size: d = 1.23) were significantly higher in Group 1 than in Group 2 (p < 0.05). Conclusion: MStim is a clinically feasible treatment option that is well tolerated with no serious side effects and is more effective than sham on both UI related clinical parameters and QoL, anxiety and sexual function in men with UI after RP. Trial Registration:ClinicalTrials.gov number, NCT04644614.