Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
BMC Complement Med Ther. 2020 Jan 23;20(1):18. doi: 10.1186/s12906-019-2784-1.
Among women suffering from urinary incontinence (UI), about one-third are diagnosed with mixed urinary incontinence (MUI), among which urgency-predominant MUI causes more shame and inconvenience to patients. The treatments for urgency-predominant MUI have limited guidelines and previous studies have indicated that electroacupuncture (EA) might be a safe and effective option. The present study aims to evaluate the effect of EA on women with urgency-predominant MUI.
The study is a multicentered, three-armed, non-inferiority randomized clinical trial. A total of 282 female patients with urgency-predominant MUI will be randomly divided into three groups, namely the EA group, sham electroacupuncture (SA) group, and solifenacin treatment group at a ratio of 1:1:1. Thirty-six sessions of acupuncture treatment over 12 weeks and solifenacin treatment over 36 weeks will be provided. The primary outcome will be the decrease of urgency urinary incontinence (UUI) episodes after 12-week treatment. Secondary outcomes will include changes in incontinence episodes, urinary frequency, urgency, severity of symptoms, and influence on quality of life, assessed using the International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) and Overactive Bladder Questionnaire Short Form (OAB-q SF). All patients will be continuously followed up until week 36 and their allocations will be statistically analyzed.
Though placebo of solifenacin is rather difficult to access and all patients in the trial cannot be fully blinded, the present study will serve as an introduction of three-armed, randomized, non-inferiority, and sham acupuncture-controlled clinical trials to the acupuncture field, in an attempt to compare the effects of EA and solifenacin for treating women with urgency-predominant MUI.
ClinicalTrials.gov: NCT03787654. Registered on 25 December, 2018.
在患有尿失禁（UI）的女性中，约有三分之一被诊断为混合性尿失禁（MUI），其中以急迫性为主的 MUI 给患者带来更多的羞耻感和不便。急迫性为主的 MUI 的治疗方法指南有限，先前的研究表明电针（EA）可能是一种安全有效的选择。本研究旨在评估 EA 对以急迫性为主的 MUI 女性的疗效。
该研究是一项多中心、三臂、非劣效性随机临床试验。共有 282 例以急迫性为主的 MUI 女性患者将按 1:1:1 的比例随机分为 EA 组、假电针（SA）组和索利那新治疗组。在 12 周内进行 36 次针刺治疗和 36 周的索利那新治疗。主要结局是 12 周治疗后急迫性尿失禁（UUI）发作次数的减少。次要结局包括失禁发作次数、尿频率、急迫性、症状严重程度和生活质量的影响，采用国际尿失禁咨询问卷简表（ICIQ-SF）和膀胱过度活动症问卷简表（OAB-q-SF）进行评估。所有患者将持续随访至第 36 周，并对其分配进行统计分析。
虽然索利那新的安慰剂很难获得，而且试验中的所有患者都不能完全被蒙蔽，但本研究将为针刺领域引入三臂、随机、非劣效性和假针刺对照临床试验，试图比较 EA 和索利那新治疗以急迫性为主的 MUI 女性的效果。
ClinicalTrials.gov：NCT03787654。注册于 2018 年 12 月 25 日。
