Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT05585450
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 preceding one month, or α-blockers, 5α-reductase inhibitor, muscarinic receptor antagonists, or any other specific medication usage in the previous two weeks unless a stable 5α-reductase inhibitor usage of over three months;
6. Severe lung, heart, liver, kidney, metabolic, or mental illness, coagulation dysfunction, or with obvious cognitive dysfunction;
7. Installed cardiac pacemaker, allergy to metal, severe fear of acupuncture or unbearable to the stimulation of EA.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05585450
Study Brief:
Protocol Section:
NCT05585450