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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT02977832
Eligibility Criteria:
Inclusion Criteria:
* 45 years of age or older
* Clinically diagnosed with mild to moderate BPH
* Prostatic volume ≥ 30 ml determined by transrectal ultrasound
* Maximum flow rate (Qmax) \< 15 ml/sec for a voided volume 150-500 ml
Exclusion Criteria:
* Participants must not have severe BPH (IPSS symptom score \>21)
* Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin).
* Patients must not have undergone prior transurethral resection of the prostate (TURP).
* Post void residual (PVD) \> 200 ml
* Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT02977832
Study Brief:
Protocol Section:
NCT02977832