NCT05585450 Effect of Electroacupuncture on Benign Prostatic Hyperplasia
| NCT ID | NCT05585450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 306 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2025-09-30 |
Trial Parameters
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Brief Summary
The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of BPH in accordance with the European Association of Urology (EAU) guideline; 2. Male participants aged between 40 and 80 years; 3. Lower urinary tract symptoms (LUTS) for at least three months; 4. IPSS total score ≥8; 5. Prostate volume ≥20 mL; 6. Urinary peak flow rate (Qmax) ≤15 mL/s; 7. Voluntary participation in the trial and signed written informed content. Exclusion Criteria: 1. Post-void residual urine volume (PVR) ≥150 mL; 2. Acute urinary retention or catheterization for outflow obstruction within the 3 months (Except for post-surgical disposable catheterization); 3. Prostate cancer or prostate-specific antigen (PSA) level ≥4.0 ng/mL; 4. Neurogenic lower urinary tract dysfunction; prostatitis; uncontrolled symptomatic urinary tract infections; urethral strictures; bladder diverticula; bladder stones; bladder cancer; history of genitourinary system surgery (prostate, bladder, urethra, etc.); 5. Previous acupuncture treatment for BPH in the pre