Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial

Zongshi Qin, Yan Liu, Kehua Zhou, Jiani Wu, Ran Pang, Ning Li, Chang Xu, Joey S W Kwong, Zhishun Liu, Zongshi Qin, Yan Liu, Kehua Zhou, Jiani Wu, Ran Pang, Ning Li, Chang Xu, Joey S W Kwong, Zhishun Liu

Abstract

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common condition affecting men of all ages. Acupuncture may be an effective treatment option for CP/CPPS, but evidence is limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.

Methods: Ten hospitals will recruit 440 participants with CP/CPPS in China from October 2017 to December 2019. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The whole study consists of 2-week baseline, 8-week treatment, and 24-week follow up. Twenty 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between week 1 and 8. The two co-primary outcomes are the proportion of responders at week 8 and week 32. Secondary outcomes include proportion of responders in the two groups at different time points; change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score; change in the NIH-CPSI subscales; change in the International Prostate Symptom Score; change in the Hospital Anxiety and Depression Scale; expectation assessments; proportions of participants in each response category of the Global Response Assessment; change in the International Index of Erectile Function 5; change in the five-level EuroQol five-dimensional questionnaire and a visual analogue scale; and changes in peak and average urinary flow rate.

Discussion: This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS.

Trials registration: ClinicalTrials.gov, NCT03213938. Registered on 5 July 2017.

Keywords: Acupuncture; Chronic pelvic pain syndrome; Chronic prostatitis; Protocol; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

This study protocol and related consent have been approved by the Research Ethical Committee of Guang’anmen Hospital (Permission number: 2017-046-KY-02). All participates will be asked to complete the consent form before recruitment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Standard protocol items: recommendation for interventional trials (SPIRIT) schedule of enrolment, interventions, and assessments. NIH-CPSI National Institutes of Health Chronic Prostatitis Symptom Index, IIEF-5 International Index of Erectile Function 5, HADS Hospital Anxiety and Depression Scale, GRA Global Response Assessment, EQ-5D-5L Five-level EuroQol five-dimensional questionnaire, VAS visual analogue scale

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