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  • Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial

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Complementary medicine
Protocol
Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial
  1. Shan Chen1,
  2. Siyou Wang2,
  3. Lihua Xuan1,
  4. Hanti Lu3,
  5. Zhikai Hu4,
  6. Chao Zhang5,
  7. Huifang Zhang1
  1. 1 Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
  2. 2 Clinical Research Section, Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
  3. 3 Clinical Evaluation and Analysis Center, The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang, China
  4. 4 Department of Computer Science, Huaqiao University, Xiamen, China
  5. 5 Rehabilitation Unit, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
  1. Correspondence to Dr Shan Chen; breezehilly{at}hotmail.com

Abstract

Introduction Electroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.

Methods and analysis This is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.

Ethics and dissemination This protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.

Trial registration number ChiCTR-IOR-17012847; Pre-result.

  • complementary medicine
  • urology
  • stroke medicine
  • stroke
  • stroke medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-021783

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    Footnotes

    • Contributors SC conceived and wrote the protocol; SW and LX contributed to the study design; HL contributed to the sample size calculation and wrote the statistical analysis plan; ZH drew the flow charts; CZ and HZ prepared the figures and tables. All authors have read and approved the final manuscript.

    • Funding This work was supported by Zhejiang Provincial Administration of Traditional Chinese Medicine (grant number 2016ZA076; 2018ZA045).

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01).

    • Provenance and peer review Not commissioned; externally peer reviewed.