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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06442020
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≤75 yrs;
* Low-risk PCa (PSA \<10 ng/mL and GS \<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
* preoperative IIEF-5 score ≥ 17;
* First PSA (45d after surgery) \<0.2
* compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
* patients able to provide a written informed consent for the trial.
Exclusion Criteria:
* anaesthesiologic contraindications to robotic surgery;
* patients submitted to pelvic radiotherapy or androgen deprivation;
* patients reporting major postoperative complications (CD≥3);
* cardiovascular contraindications to PDE5i medical treatment.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06442020
Study Brief:
Protocol Section:
NCT06442020