Acupuncture for Erectile Dysfunction

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• The change from baseline in the International Erectile Function Index-5 (IIEF-5) score [Time frame: Week 8]

Secondary outcome measures (9)

• The change from baseline in the International Erectile Function Index-5 (IIEF-5) score [Time frame: Weeks 4, 20 and 32.]
• Change from baseline in the Erection Hardness Score (EHS). [Time frame: 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. [Time frame: Weeks 4, 8, 20 and 32]
• Change from baseline in the International Prostate Symptom Score (IPSS) score. [Time frame: Weeks 4, 8, 20 and 32]
• Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score. [Time frame: Weeks 4, 8, 20 and 32]
• Change from baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) and VAS scores. [Time frame: Weeks 4, 8, 20 and 32]
• Assessment of patient expectations for acupuncture. [Time frame: Baseline]
• The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) [Time frame: Weeks 8 and 32]
• Patient Assessment of Blinding Effectiveness [Time frame: Within 5 minutes after any acupuncture session in Week 8.]

Eligibility criteria

Inclusion criteria

• Conforms to the diagnosis of CP/CPPS and pED at the same time;
• Aged between 18-50 years old;
• 8≤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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07324148 · 2025_267_KY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗