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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07308002
Eligibility Criteria:
Inclusion Criteria:
* • Men ≥40 years with LUTS/BPH.
* IPSS ≥8, Qmax 5-15 mL/s (voided volume ≥150 mL), PVR \<200 mL.
* Sexually active within the past month (for ejaculatory outcomes).
* BPH-treatment naïve: no prior use of antimuscarinics or 5-α-reductase inhibitors (5-ARIs) and agrees not to initiate these agents during the trial.
Exclusion Criteria:
* • PVR ≥ 200 mL.
* Prior prostate/ radical pelvic surgery (that affect pelvic innervation).
* Neurogenic bladder (atonic/ hypotonic bladder).
* Severe hepatic/renal insufficiency.
* Significant cardiovascular or cerebrovascular disease.
* Any indication of surgical treatment (vesical stones, chronic urine retention, recurrent attacks of acute urine retention, recurrent attacks of gross hematuria, hydronephrosis)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT07308002
Study Brief:
Protocol Section:
NCT07308002