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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00884104
Eligibility Criteria:
Inclusion Criteria:
* IPSS ≥ 12
* Symptoms of OAB as verified by the V8 (≥8)
* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
* Mean urinary frequency ≥8 times/24 hours
* Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)
Exclusion Criteria:
* Treatment within the 14 days preceding treatment with any alpha blocker drugs
* A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT00884104
Study Brief:
Protocol Section:
NCT00884104