Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial

Yuanjie Sun, Yan Liu, Huan Chen, Yan Yan, Zhishun Liu, Yuanjie Sun, Yan Liu, Huan Chen, Yan Yan, Zhishun Liu

Abstract

Introduction: Evidence specific for stress-predominant mixed urinary incontinence is still lacking at present, and acupuncture may relieve the symptoms. We plan to conduct this multi-centre, three-armed, randomised controlled trial to investigate the efficacy and safety of electroacupuncture among women with stress-predominant mixed urinary incontinence.

Methods and analysis: The trial will be conducted at five hospitals in China. Two hundred thirty-two eligible women will be randomly assigned (2:1:1) to the electroacupuncture, sham electroacupuncture or waiting-list group to receive either 24-session acupuncture/sham acupuncture treatment over 8 weeks and 24-week follow-up or 20-week watchful waiting. The primary outcome is the proportion of participants with at least 50% reduction in mean 24-hour stress incontinence episode frequencies from baseline to week 8. The outcome will be analysed with the intention to treatpopulation (defined as participants randomised) with a two-sided p value of less than 0.05 considered significant.

Ethics and dissemination: The protocol has been approved by Guang'anmen Hospital Institutional Review Board (2019-241-KY). Detailed information of the trial will be informed to the participants, and written informed consent will be obtained from every participant. Results of the trial are expected to be published in a peer-reviewed journal.

Trial registration number: ClinicalTrials.gov Registry (NCT04299932).

Keywords: bladder disorders; complementary medicine; urinary incontinences.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart.
Figure 2
Figure 2
Study schedule. *Only for participants in electroacupuncture and sham electroacupuncture groups. ICIQ-SF, International Consultation on Incontinence Questionnaire-Short Form; OAB-q SF, Overactive Bladder Questionnaire Short Form; PGI-I, Patient Global Impression of Improvement.

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