Acupuncture for Erectile Dysfunction

NCT07324148 | Not Yet Recruiting

• 1 other identifier: 2025_267_KY
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the International Erectile Function Index-5 (IIEF-5) score

  IIEF-5 is a short verified scale used to evaluate erectile function. It Includes 5 items, with each item ranging from 1-5 points. The total score of IIEF-5 ranges from 5-25 points, with 21-25 indicating normal, 12-21 mild disorder, 8-11 moderate disorder and 5-7 severe disorder.

  Week 8

Secondary Outcomes (9)

• The change from baseline in the International Erectile Function Index-5 (IIEF-5) score

  Weeks 4, 20 and 32.

• Change from baseline in the Erection Hardness Score (EHS).

  Weeks 4, 8, 20 and 32

• Proportion of patients with a reduction of ≥6 points from baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score.

  Weeks 4, 8, 20 and 32

• Change from baseline in the International Prostate Symptom Score (IPSS) score.

  Weeks 4, 8, 20 and 32

• Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score.

  Weeks 4, 8, 20 and 32

Other Outcomes (6)

• Safety assessment

  Weeks 1-32

• Combination treatment

  Weeks 1-32

• Changes in peripheral immune cell types

  Baseline, Week 8.

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Device: Acupuncture

Sham acupuncture group

SHAM COMPARATOR

Device: Sham acupuncture

Interventions

Acupuncture DEVICE

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).

Acupuncture group

Sham acupuncture DEVICE

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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Conforms to the diagnosis of CP/CPPS and pED at the same time;
• Aged between 18-50 years old;
• ≤IIEF-5 score≤21
• Have a fixed sexual partner and a regular sexual intercourse of ≥1 time/week during treatment period;
• Voluntarily sign an informed consent form.

You may not qualify if:

• Patients with drug-induced or organic ED.
• The existence of lesions that may affect erectile function, such as penile cancer, penile sclerosis, penile anatomical deformity, testicular cancer, urinary system stones or neuropathy, etc.
• History of trauma or surgery in pelvic region.
• Patients with hypogonadism.
• Usage of drugs or therapies that relieve CP/CPPS or ED symptoms in the previous 1 month.
• Have received hormonal or psychiatric drugs in the previous 3 months.
• Bladder outlet obstruction, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumors, prostate cancer, penile cancer, penile stone, other types of prostatitis.
• With a residual urine ≥100ml.
• Symptomatic urinary tract infection.
• Diseases affecting the function of the lower urethra, such as multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, caua equina nerve injury, stroke and multisystem atrophy, etc.
• Severe diseases in heart, lung, brain, liver, kidney and hematopoietic system , mental illness and obvious cognitive function disorders.
• Patients with poor compliance

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yuanjie Sun

CONTACT

+86 18810337542; puzhisun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with publication until until six months after publication.
• Access Criteria: Formal request should be sent to the author (puzhisun@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement