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. 2024 Jul 20;14(7):e080743.
doi: 10.1136/bmjopen-2023-080743.

Electroacupuncture for lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for a randomised controlled trial

Lili Zhu #  1 , Yan Yan #  1 , Jinna Yu  1 , Yan Liu  2 , Yuanjie Sun  1 , Yu Chen  3 , Jiufei Fang  1 , Zhishun Liu  4
Affiliations

Electroacupuncture for lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for a randomised controlled trial

Lili Zhu et al. BMJ Open. .

Abstract

Introduction: Benign prostatic hyperplasia (BPH) is a condition commonly seen among men aged over 40, significantly affecting their quality of life and typically accompanied by lower urinary tract symptoms (LUTS). Acupuncture presents a potentially effective treatment option; however, the exact effects remain uncertain. Therefore, we design this multicentre randomised trial to evaluate the efficacy and safety of electroacupuncture (EA) for relieving LUTS in men with BPH.

Methods and analysis: A two-arm, sham-controlled, subject-blinded and assessor-blinded trial will be conducted in 11 hospitals in China to compare EA with sham electroacupuncture (SA) in treating moderate to severe LUTS of BPH among men aged 40-80. A total of 306 eligible male patients will be recruited and assigned at a 1:1 ratio to receive either EA or SA for 24 sessions over a succession of 8 weeks, with 24 weeks of follow-up. The primary outcome will be the proportions of participants with at least 30% reduction in the International Prostate Symptom Score total score from baseline at weeks 8 and 20. All statistical analyses will be conducted in accordance with the intention-to-treat principle, and a two-tailed p value less than 0.05 will be considered statistically significant.

Ethics and dissemination: The trial has been approved by the institutional review board of Guang'anmen Hospital (2022-203-KY), as well as other recruitment centres. Each participant will receive the detailed information of the trial, and sign the written informed consent. The results of the trial are expected to be published in a peer-reviewed journal.

Trial registration number: NCT05585450.

Keywords: Clinical Trial; Prostate; Prostate disease.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Study flowchart. BPH, benign prostatic hyperplasia.
Figure 2
Figure 2. Study Schedule.
See this image and copyright information in PMC

References

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