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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02749604
Eligibility Criteria:
Inclusion Criteria:
* To be eligible in the study, patient must fulfill the following criteria:
1. Age ≥ 50 years
2. ASA (American society of anesthesiologists) score ≤3.
3. TRUS estimated prostate weight 30-80 grams.
4. Sexually interested and having continuous relationship with the same partner (interested).
5. BOOI (bladder outlet obstructing index) ≥ 20 as per pressure flow study
Exclusion Criteria:
* Patients with any of the following are to be excluded:
1. Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome
2. Documented or suspected prostate cancer (significantly elevated PSA, positive biopsy for prostate cancer guided by TRUS)
3. Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled DM (\> 10 years) cerebral stroke, Parkinsonism
4. Active urinary tract infection
5. Urodynamic changes consistent with urethropathy or detrusor hypocontractility
6. Previous pelvic surgeries
7. History of pelvic radiotherapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT02749604
Study Brief:
Protocol Section:
NCT02749604