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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT01786967
Eligibility Criteria:
Inclusion Criteria:
* Women ≥ 50 years
* ≥ 3 UUI episodes on a 3-day voiding diary
* Urge-predominant incontinence, \>50% of total incontinence episodes
* No history of failure to fesoterodine
* 2-week washout period if currently on an anticholinergic for UUI
* Willingness to avoid off-protocol UUI therapy during the study period
* Post Void Residual (PVR) \<150 mL
Exclusion Criteria:
* Contraindications to fesoterodine (e.g., bladder outlet obstruction, narrow angle glaucoma, myasthenia gravis, severe hepatic or renal impairment)
* Inability to complete study-related items and visits - i.e., cognitive impairment based on Mini-Cog test score (exclude if score of 0 or 1-2 (Abnormal))
* Urinary retention requiring catheterization
* Symptomatic, untreated urinary tract infection not resolved prior to starting fesoterodine
* Botulinum toxin injection for UUI in the last year
* Current therapy with peripheral or sacral neuromodulation
* Neurologic conditions that may affect urinary function (stroke, multiple sclerosis, spinal cord injury, Parkinson's disease)
* Women taking potent CYP3A4 inhibitors
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT01786967
Study Brief:
Protocol Section:
NCT01786967