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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT04198103
Eligibility Criteria:
Inclusion Criteria:
* Male
* ≥ 50 years of age
* International Prostate Symptoms (IPSS) ≥12
* Peak urinary flow rate (Qmax): \<15 ml
* Prostate volume: ≥ 30 ml, measured by transrectal ultrasound
* Post-void residual (PVR): \<400 ml
* Signed informed consent
Exclusion Criteria:
* MRI signs of malignancy confirmed by biopsy investigation
* urethral stenosis
* serious coagulation disorders
* inadequate compliance
* ischemic pathology in the previous six months
* active phase inflammatory pathology
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT04198103
Study Brief:
Protocol Section:
NCT04198103