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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT06794333
Eligibility Criteria:
Inclusion Criteria:
* PSA levels under 4 ng/ml (if PSA is over 4 ng/ml, a multiparametric prostate magnetic resonance will be performed; if a lesion with a PIRADS score over 2 is detected, a prostate biopsy will be conducted);
* Post void residual (PVR) over 50 ml;
* Maximum flow (Qmax) under 15 ml/s;
* IPSS score over 7;
* The possibility of undergoing transrectal ultrasound to assess the size of the prostate and prostate adenoma;
* Negative urinary culture.
Exclusion Criteria:
* Diabetes;
* Overactive or Underachieve bladder;
* Contraindications for performing MRI or prostate biopsy in cases where PSA is over 4 ng/ml;
* Intolerance to transrectal ultrasound;
* Intolerance or allergy to local anesthetics.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT06794333
Study Brief:
Protocol Section:
NCT06794333