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Open Access Study protocol

Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol

Baoyan Liu1, Yang Wang1, Huanfang Xu1, Yuelai Chen2, Jiani Wu1, Qian Mo1 and Zhishun Liu1*

Author Affiliations

1 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No.5 Beixiange Street, Beijing, Xicheng District, China

2 Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, Pudong, China

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BMC Complementary and Alternative Medicine 2014, 14:301  doi:10.1186/1472-6882-14-301

Published: 15 August 2014

Abstract

Background

In women with mixed urinary incontinence, pelvic floor muscle training and solifenacin is the recommended conservative treatment, while electroacupuncture is a safe, economical and effective option.

Methods/Design

In this prospective, multi-center, randomized controlled trial, five hundred women with mixed urinary incontinence, from 10 centers will be randomized to receive either electroacupuncture or pelvic floor muscle training plus solifenacin. Women in the acupuncture group will receive electroacupuncture for 3 sessions per week, over 12 weeks, while women in the control group will receive pelvic floor muscle training plus solifenacin (5 mg once daily) for 36 weeks. The primary outcome measure is the proportion of change in 72-hour incontinence episode frequency from baseline to week 12. The secondary outcome measures include eleven items, including proportion of participants with ≥50% decrease in average 72-h incontinence episode frequency, change from baseline in the amount of urine leakage and proportion of change from baseline in 72-h incontinence episode frequency in week 25–36, and so forth. Statistical analysis will include covariance analysis, nonparametric tests and t tests.

Discussion

The objective of this trial is to compare the efficacy and safety of electroacupuncture versus pelvic floor muscle training plus solifenacin in women with moderate and severe mixed urinary incontinence.

Trial registration

ClinicalTrials.gov Identifier: NCT02047032

Keywords:
Electroacupuncture; Pelvic floor muscle training; Solifenacin; Mixed urinary incontinence