Sleep Medicine Center, LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Acupuncture Department, Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai, China.
BMJ Open. 2024 Sep 12;14(9):e076374. doi: 10.1136/bmjopen-2023-076374.
Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate.
This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King's Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population.
Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER : NCT05798403.
膀胱过度活动症（OAB）影响全球约 5 亿人，女性患病率高于男性，严重影响女性患者的生活质量。OAB 的治疗选择目前有限。先前的研究表明，电针可能是女性 OAB 的一种可行治疗方法，但缺乏高质量的临床证据。本研究旨在通过与琥珀酸索利那新比较，评估电针对女性 OAB 的有效性，即作为一种安全有效的非药物治疗方法。
这是一项多中心、单盲、双盲、随机对照非劣效性临床试验，涉及 204 名符合条件的 OAB 女性参与者。参与者将以 1:1 的比例随机分配至电针组（接受电针和安慰剂）或琥珀酸索利那新组（接受假电针和琥珀酸索利那新）。每位参与者将在 4 周内接受 12 次电针（或假电针）治疗和琥珀酸索利那新（或安慰剂）治疗。主要结局测量指标将是第 4 周与基线相比，24 小时内排尿次数的变化百分比。次要结局将包括试验第 2、8 和 16 周时，24 小时内排尿次数的百分比减少，OAB 症状评分，基于 3 天排尿日记的 24 小时内尿失禁和尿急次数，OAB 问卷，广泛性焦虑症量表-7，King's 健康问卷和参与者对治疗效果的自我评价。整个研究过程中都将监测不良事件。将对意向治疗人群和方案人群进行疗效分析。
上海中医药大学龙华医院医学伦理委员会已批准（批准号：2022LCSY097）。每个参与者在随机分组前都将签署一份书面知情同意书。本研究的结果将发表在同行评议的期刊上。
NCT05798403。
