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 hydrangea red sensation 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 here 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.