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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT03059134
Eligibility Criteria:
Inclusion Criteria:
1. Symptoms of OAB for at least 12 weeks before initiation of the run-in period;
2. An average of ≥8 micturitions per 24 hours,
3. An average of ≥1 episode of urgency or urgency incontinence per 24-hours, during a 3-day micturition diary period.
Exclusion Criteria:
1. Stress urinary incontinence as a predominant symptom at screening;
2. Urinary tract infection, urinary stone, interstitial cystitis or a history of recurrent urinary tract infection;
3. Confirmed post-void residual (PVR) volume of ≥100 mL or more or with a clinically significant lower urinary tract obstructive disease;
4. Proven neurogenic bladder such as stroke, Parkinson's disease, spinal cord injury, multiple sclerosis;
5. Overt bladder outlet obstruction not adequately controlled.
6. Severe medical disease that prohibit patients to undergo clinical investigation.
7. Patient is currently taking medications that might affect lower urinary tract function, such as α1-adrenoreceptor antagonists; medication for diabetes insipidus, antidepressants, 5α reductase inhibitors, capsaicin, resiniferatoxin, or botulinum toxin into the bladder, were also restricted.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03059134
Study Brief:
Protocol Section:
NCT03059134