NCT07324148

Acupuncture for Erectile Dysfunction

Acupuncture for Erectile Dysfunction Among Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a prevalent chronic urological disease. CP/CPPS severely impacts patients' quality of life. It is characterized by recurrent pelvic floor pain, lower urinary tract symptoms, and often accompanied by psychological issues and sexual dysfunction (duration ≥3 months, no confirmed infection/pathology). The investigators have completed a large-sample, multi-center randomized controlled trial (RCT) involving 440 patients with CP/CPPS before. The clinical trial confirmed the sustained efficacy of acupuncture for the symptoms of pain, lower urinary tract symptoms, and anxiety and depression among patients with CP/CPPS. However, the trial revealed no significant improvements in sexual dysfunction in the acupuncture group compared to the sham acupuncture group after 8 weeks of treatment.To address this limitation, the current study is designed, which aims to optimize the clinical acupuncture protocol for CP/CPPS and evaluate whether it can enhance outcomes for psychogenic erectile dysfunction (ED) associated. Additionally, mass cytometry and liquid suspension chip technology will be used to explore systemic and local immune mechanisms underlying acupuncture's effects for CP/CPPS. Functional magnetic resonance imaging (fMRI) and metabolomics will be integrated to analyze patients' systemic states from central nervous system and metabolic perspectives, comprehensively elucidating the multi-dimensional mechanisms by which acupuncture alleviates CP/CPPS.

Conditions

• Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
• Erectile Dysfunctions
• Acupuncture

Interventions

Type	Name	Description
DEVICE	Acupuncture	Sanyinjiao (SP6), Zhongliao(BL33), Shenshu(BL23), Huiyang(BL35), Guilai(ST29), Guanyuan(CV4), Shenmen(HT7) and Baihui(GV20) are selected as acupoints protocol. Acupuncture treatment consists of 20 sessions over an 8-week period (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
DEVICE	Sham acupuncture	The participants in the sham acupuncture group will receive sham acupuncture treatment in SP6, BL33, BL23, BL35, ST29, HT7, CV4, and GV20. The duration and frequency of sessions are the same as in the acupuncture group. Blunt needles will be inserted through the fixed pad to reach the surface of the skin without piercing. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2026-01-07
• Last updated: 2026-01-08