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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Electroacupuncture to treat with Overactive Bladder in Postmenopausal Women: study protocol for a multicenter, randomized, controlled, parallel clinical trial

Authors: Eun-Young Nam, Ju-Yeon Park, Junyoung Jo, Seung-Hyun Jung, Chi-Yeon Lim, Dong-Il Kim

Published in: Trials | Issue 1/2018

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Abstract

Background

Electroacupuncture has been used for treatment in patients with overactive bladder. This study was conducted to evaluate the efficacy and safety of electroacupuncture for treating overactive bladder of postmenopausal women.

Methods/design

This is a multicenter, randomized controlled, parallel clinical trial. Two hundred ninety participants with overactive bladder syndrome will be recruited from Dongguk University Bundang Oriental Hospital and Cheonan Korean Medicine Hospital of Daejeon University and randomly allocated into one of two groups in a 1:1 ratio. One group will receive electroacupuncture (EA) and the other acupuncture (AC). The allocation will be concealed from both participants and assessors. The study period will be about 10 weeks, including 6 weeks of electroacupuncture or acupuncture treatment and a four week follow-up period. Both EA group and AT group will undergo acupuncture at 7 fixed points, and the EA group will undergo electronic stimulation at 6 points. The primary outcome will be the average number of micturitions per 24 h based on a 3-day bladder diary. The secondary outcome will comprise the 3-day bladder diary, the overactive bladder symptom score and the results of the King’s health questionnaire.

Discussion

The results of this trial will provide information regarding the efficacy and safety of electroacupuncture for treating overactive bladder in postmenopausal women.

Trial registration

ClinicalTrials.gov, NCT03260907. Registered on 24 August 2017.
Appendix
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Metadata
Title
Electroacupuncture to treat with Overactive Bladder in Postmenopausal Women: study protocol for a multicenter, randomized, controlled, parallel clinical trial
Authors
Eun-Young Nam
Ju-Yeon Park
Junyoung Jo
Seung-Hyun Jung
Chi-Yeon Lim
Dong-Il Kim
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2715-3

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