Data Sheet 1_Effect of electro-acupuncture on postpartum urinary retention: a protocol for multicenter, randomized and placebo-controlled trial.docx

BackgroundPostpartum 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.
MethodsThis 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.
ConclusionThis 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 registrationChinese Clinical Trial Registry, ChiCTR2300078039.