Acupuncture for Erectile Dysfunction

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Not yet enrolling

Conditions

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Acupuncture

Erectile Dysfunctions

Treatments

Device: Acupuncture

Device: Sham acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT07324148

2025_267_KY

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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