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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT06758466
Eligibility Criteria:
Inclusion Criteria:
* Male patients aged 45-80 years diagnosed with symptomatic BPH.
* Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.
* Moderate to severe LUTS with an IPSS of ≥ 8.
* Failure of medical management.
* Patients able to provide written informed consent.
Exclusion Criteria:
* History of prostate cancer.
* History of previous prostate surgery (including any procedure for BPH or prostate cancer).
* History of urethral stricture or bladder neck contracture.
* Neurogenic bladder dysfunction.
* Significant coagulopathy.
* Uncontrolled urinary tract infection.
* Patient on anticoagulant medication.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT06758466
Study Brief:
Protocol Section:
NCT06758466