The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trialReport as inadecuate




The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 14:315

First Online: 30 September 2013Received: 06 June 2013Accepted: 16 September 2013DOI: 10.1186-1745-6215-14-315

Cite this article as: Liu, Z., Xu, H., Chen, Y. et al. Trials 2013 14: 315. doi:10.1186-1745-6215-14-315

Abstract

BackgroundAlthough available evidence relating to its effectiveness is weak, acupuncture is used as an alternative therapy for stress urinary incontinence. We report a protocol of a randomized controlled trial using electroacupuncture the passing of a weak current between inserted acupuncture needles to treat women with pure stress urinary incontinence.

Methods-DesignThis is a large-scale multicenter subject-blinded randomized controlled trial. A total of 500 women with pure stress urinary incontinence will be randomly assigned to two groups: a treatment group and a control group. The treatment group will receive electroacupuncture with deep needling at acupuncture points BL33 and BL35. The control group will receive sham electroacupuncture with non-penetrating needling at sham locations for the acupuncture points of BL33 and BL35. Participants will be given three sessions a week for 6 weeks. A 24-week-long follow-up will be conducted. The primary outcome will be the change in amount of urine leakage at the sixth week from a baseline measured by a 1-h pad test. The secondary outcomes include: the 72-h incontinence episode frequency based on a 72-h bladder diary; the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form; the degree of urinary incontinence based on a 72-h bladder diary; self-assessment of the therapeutic effect; weekly consumption of pads; application of other treatments for stress urinary incontinence; and subgroup analysis stratified by incontinence severity. The safety of electroacupuncture will also be assessed.

DiscussionThis trial will help to identify whether electroacupuncture is effective for stress urinary incontinence, and, if so, whether it is a therapeutic effect rather than a placebo effect.

Trial RegistrationClinical Trials.gov NCT01784172

KeywordsElectroacupuncture Pure stress urinary incontinence Efficacy RCT Study protocol AbbreviationsEAElectroacupuncture

ITTIntent to treat

LUTSLower urinary tract symptoms

PFMTPelvic floor muscle training

RCTsRandomized controlled trials

SUIStress urinary incontinence

VASVisual analogue scale.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-14-315 contains supplementary material, which is available to authorized users.

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Author: Zhishun Liu - Huanfang Xu - Yuelai Chen - Liyun He - Jia Liu - Shiyan Yan - Ruosang Du - Jiani Wu - Baoyan Liu

Source: https://link.springer.com/



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