Effect of electro-acupuncture on postpartum urinary retention: a protocol for multicenter, randomized and placebo-controlled trial

电针疗法对产后尿潴留的影响:一项多中心、随机、安慰剂对照试验方案

阅读:1

Abstract

BACKGROUND: Postpartum urinary retention (PUR) is a common and clinically relevant complication after delivery. Although urinary catheterization can provide temporary relief from voiding disorders, it is associated with discomfort, pain, potential urethral trauma, and an increased risk of urinary tract infection. Preliminary randomized and observational studies have suggested that acupuncture may facilitate voiding and early bladder recovery in PUR; however, the current evidence base remains limited by small sample sizes, heterogeneous methods, and risk of bias. To address these gaps, we designed a multicenter, randomized, sham-controlled clinical trial to evaluate whether electroacupuncture (EA) reduces the incidence of PUR and improves early bladder recovery. METHODS: This is a multicenter, randomized, parallel-group clinical trial conducted in China to investigate the impact of EA intervention on the incidence of PUR. Patient screening and enrollment will take place at four hospitals in China: the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin Shuige Hospital and Second People's Hospital of Fengrun District, Tangshan City. Patients will be randomly assigned to either the EA group or the sham acupuncture group, with 330 patients in each group. Each acupuncture treatment will comprise three 30-min sessions over 2 days (the first hour, the first day, and the second day after delivery). The primary outcome measure is the incidence of PUR. Adverse events will be recorded, and their impact will be analyzed at the end of the trial. CONCLUSION: This multicenter, randomized, sham-controlled trial is designed to rigorously evaluate whether EA reduces the incidence of PUR and accelerates early bladder recovery. The findings will contribute evidence to inform the role of non-pharmacologic interventions in postpartum rehabilitation. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2300078039.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。