Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Urge urinary incontinence, characterized by unpredictable and embarrassing large volume urine leakage, is a major health issue for elderly women, as it is incredibly common and significantly impairs quality of life. Although anticholinergic medications are the most common therapy, the investigators are unable to predict an individual's response to a particular drug in terms of both effectiveness and side effects. Through genetic evaluation, the investigators have the potential to personalize and optimize drug therapy for millions of elderly women suffering from urge incontinence.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute on Aging (NIA)
• Treatments: Fesoterodine

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