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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT02252367
Eligibility Criteria:
Inclusion Criteria:
* adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia;
* treatment with alpha-blockers (Tamsulosin 0.4 mg/die)
* being capable of giving informed consent.
Exclusion Criteria:
* participation in another clinical study;
* known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value \>10 ng/mL;
* suspected lack of the participant's compliance;
* known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);
* nown neurogenic bladder (i.e. Parkinson's disease);
* suspected or proven urinary infections;
* presence of bladder stone.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02252367
Study Brief:
Protocol Section:
NCT02252367