Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Urinary Retention After Radical Hysterectomy for Cervical Cancer: Study Protocol for A Pilot Randomized Controlled Trial

经皮穴位电刺激对宫颈癌根治性子宫切除术后尿潴留的影响:一项试点随机对照试验的研究方案

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Abstract

INTRODUCTION: Postoperative urinary retention (POUR) is a common complication in women after radical hysterectomy for cervical cancer and may substantially impair quality of life. Transcutaneous Electrical Acupoint Stimulation (TEAS) has shown potential in alleviating POUR, but its efficacy remains to be further evaluated. This pilot study aims to preliminarily evaluate the effect of TEAS in women who develop POUR after radical hysterectomy for cervical cancer. METHODS AND ANALYSIS: This protocol describes a prospective, single-blinded, single-center pilot randomized controlled trial that will compare TEAS with sham TEAS for the management of POUR after radical hysterectomy for cervical cancer. A total of 76 eligible patients will be randomly assigned in a 1:1 ratio to the TEAS group or the sham TEAS group. Participants in the TEAS group will receive TEAS once daily for 2 weeks, while those in the sham TEAS group will receive sham stimulation on the same schedule. The primary outcome is the change in post-void residual (PVR) volume. Secondary outcomes include the rate of successful urinary catheter removal, incidence of urinary tract infection (UTI), and quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30). Safety will also be evaluated. All statistical analyses will be conducted according to the intention-to-treat (ITT) principle. ETHICS/DISSEMINATION: The trial has received ethics approval from the Medical Ethics Committee of Zhejiang Cancer Hospital (14 October 2025; IRB-2025-1262). Findings will be disseminated in peer-reviewed journals to inform clinical decision-making in POUR management. TRIAL REGISTRATION NUMBER: ITMCTR2025002091.

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