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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT01925456
Eligibility Criteria:
Inclusion Criteria:
1. urinary urgency for at least 3 months.
2. Subjects must have mean of ≥ 8 voids per 24 hours
3. and ≥ 1 urgency episode per 24 hours and a rating of at least moderate bother on the single item
4. Patient Perception of Bladder Condition.
Exclusion Criteria:
1. \< 18 years
2. predominant stress incontinence as measured by the validated 3-Incontinence Questionnaire
3. current/recent use (≤6 m) or contra-indication to anti-cholinergic medication for OAB
4. severe voiding difficulties in the judgment of the investigator
5. men on unstable use of alpha blockers/5-alpha reductase inhibitors
6. severe neurologic disease
7. anti-incontinence or prolapse surgery
8. pregnancy ≤6 months
9. pelvic neuromodulation other lower urinary tract disorder such as calculus, urethral diverticulum, current or recurrent urinary tract infections.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01925456
Study Brief:
Protocol Section:
NCT01925456