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Electroacupuncture versus solifenacin for women with urgency-predominant mixed urinary incontinence: a protocol for a three-armed non-inferiority randomized controlled trial.

电针与索利那新治疗女性急迫性混合性尿失禁: 一项三臂非劣效性随机对照试验的方案。

  • 影响因子:0
  • DOI:10.1186/s12906-019-2784-1
  • 作者列表:"Sun Y","Liu Y","Su T","Sun J","Wu Y","Liu Z
  • 发表时间:2020-01-23
Abstract

BACKGROUND: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. METHODS: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. DISCUSSION: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. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03787654. Registered on 25 December, 2018.

摘要

背景: 在患有尿失禁 (UI) 的女性中,约3分之1被诊断为混合性尿失禁 (MUI),其中以尿急为主的MUI给患者带来更多的耻辱和不便。急迫性MUI的治疗指南有限,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对急迫性MUI女性的影响。 方法: 本研究是一项多中心、三臂、非劣效性随机临床试验。将282例以尿急为主的女性患者按1:1:1的比例随机分为3组,分别为电针组、假电针 (SA) 组、索利那新治疗组。将提供超过12周的36次针灸治疗和超过36周的索利那新治疗。主要结果将是治疗12周后急迫性尿失禁 (UUI) 发作的减少。次要结局将包括失禁发作、尿频、尿急、症状严重程度和对生活质量的影响的变化,使用国际失禁咨询问卷简表 (ICIQ SF) 和膀胱过度活动症问卷简表 (OAB-q SF) 进行评估。所有患者将连续随访至第36周,并对其分配进行统计分析。 讨论: 尽管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失明,但本研究将作为三臂、随机、非劣效性和假针灸对照临床试验引入针灸领域,试图比较EA和索利那新治疗急迫性MUI妇女的效果。 试验注册: ClinicalTrials.gov: nct03787654。2018年12月25日登记。

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