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

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 wo...

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Autores principales:	Yan Yan, Zhishun Liu, Huan Chen, Yuanjie Sun
Formato:	article
Lenguaje:	EN
Publicado:	BMJ Publishing Group 2021
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/bb0aca3d671b4e5d86b51a36275083e5
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spelling	oai:doaj.org-article:bb0aca3d671b4e5d86b51a36275083e52021-11-18T08:30:06ZElectroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial10.1136/bmjopen-2020-0384522044-6055https://doaj.org/article/bb0aca3d671b4e5d86b51a36275083e52021-01-01T00:00:00Zhttps://bmjopen.bmj.com/content/11/1/e038452.fullhttps://doaj.org/toc/2044-6055Introduction 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).Yan YanZhishun LiuHuan ChenYuanjie SunBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 11, Iss 1 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Yan Yan Zhishun Liu Huan Chen Yuanjie Sun Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial
description	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).
format	article
author	Yan Yan Zhishun Liu Huan Chen Yuanjie Sun
author_facet	Yan Yan Zhishun Liu Huan Chen Yuanjie Sun
author_sort	Yan Yan
title	Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial
title_short	Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial
title_full	Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial
title_fullStr	Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial
title_full_unstemmed	Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial
title_sort	electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial
publisher	BMJ Publishing Group
publishDate	2021
url	https://doaj.org/article/bb0aca3d671b4e5d86b51a36275083e5
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Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial

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