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Open Access Study protocol

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

Zhishun Liu1, Huanfang Xu1, Yuelai Chen2, Liyun He3, Jia Liu3, Shiyan Yan3, Ruosang Du1, Jiani Wu1 and Baoyan Liu1*

Author Affiliations

1 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China

2 Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China

3 China Academy of Chinese Medical Sciences, Beijing 100700, China

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Trials 2013, 14:315  doi:10.1186/1745-6215-14-315

Published: 30 September 2013

Abstract

Background

Although 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/Design

This 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.

Discussion

This 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 Registration

Clinical Trials.gov NCT01784172

Keywords:
Electroacupuncture; Pure stress urinary incontinence; Efficacy; RCT; Study protocol