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:
NCT04420533
Eligibility Criteria:
Inclusion Criteria:
* Sexually active men with OAB ≥ 20 years
* Diagnosed with OAB based on OABSS (OABSS urgency score of ≥2 and sum score of ≥3)
* Patients can sign informed consent and record voiding diary
Exclusion Criteria:
* Concurrent use of PDE5 inhibitor or testosterone therapy during study period
* History of stress urinary incontinence
* Neurologic conditions associated with OAB symptoms
* Evidence of active urinary tract infection or urinary tract stone at screening
* Confirmed or suspected genitourinary tract or pelvic malignancy
* Genitourinary tract operation during the 3-month period prior to baseline
* Postvoid residual urine volume (PVR) ≥ 100 mL
* History of uncontrolled hypertension (systolic \>180 mmHg and/or diastolic \>110 mmHg)
* History of intolerance to mirabegron
* History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study protocol
* Patient had received intravesical onabotulinumoxinA treatment within recent 6 months
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT04420533
Study Brief:
Protocol Section:
NCT04420533