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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT06849258
Eligibility Criteria:
Inclusion Criteria:
* Male subjects \> 45 years of age who have symptomatic BPH
* International Prostate Symptom Score (IPSS) score \>13
* Peak urinary flow rate (Qmax): \>5 mL/sec and \<13 mL/sec with minimum voided volume of \>125 mL
* Post-void residual (PVR) \<250 mL
* Prostate volume 25 to 80 mL
* Prostatic urethral length 20-50 mm
* Able to complete the study protocol and visits
Exclusion Criteria:
* Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
* Prior minimally invasive intervention or surgical intervention of the prostate or urethra
* PSA \>10 ng/mL
* Bladder cancer or bladder stones
* Active urinary tract infection (UTI)
* Uncontrolled diabetes
* Part of a vulnerable population (cognitively challenged or are incarcerated)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT06849258
Study Brief:
Protocol Section:
NCT06849258