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

Completed · Phase 3

Conditions studied: Urge Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT01786967

Run by

University of North Carolina, Chapel Hill

People needed

61

Starts

2012-09-01

Expected to finish

2017-12-31

Last updated by the study team

2020-03-18

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UNC-Chapel Hill, Dept of Ob/Gyn — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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