Efficacy of electrical pudendal nerve stimulation versus pelvic floor muscle training in treating postradical prostatectomy urinary incontinence: study protocol for a randomised controlled trial.

INTRODUCTION

Urinary incontinence (UI) is one of the main complications of radical prostatectomy. Electrical pudendal nerve stimulation (EPNS) has been used to treat stress UI based on its mechanism of passive pelvic floor muscle contraction reported in the previous research. However, there are no studies comparing the effects of EPNS and active pelvic floor muscle training (PFMT) in the treatment of postradical prostatectomy UI (PPUI). Here, we describe the protocol for a randomised controlled trial to evaluate the efficacy of EPNS in treating PPUI compared with PFMT.

METHODS AND ANALYSIS

This study is designed as an open-label randomised controlled trial with blinded assessment and analysis. A total of 90 eligible men will be randomly allocated to two groups. The treatment group (n=45) will receive EPNS while the control group will perform PFMT by doing the Kegel exercise. Forty EPNS treatment sessions will occur over a period of 8 weeks. The primary outcome measure will be improvement rate, and the secondary outcome measures, the number of pads used, 24-hour pad test, and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form will be compared between baseline and the study endpoint. The International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life and care compared as the quality of life and satisfaction outcomes between groups.

ETHICS AND DISSEMINATION

This protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval no. 2021 KL-040-02). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ChiCTR2200055461.