Phase 3 N=61 Treatment

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

Urge Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01786967 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Percentage With Treatment Success — 74.1; 75.0 percentage of participants — p=1.0

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fesoterodine Fumarate (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: Female
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage With Treatment Success	74.1; 75.0	1.0
SECONDARY Percentage With Moderate to Severe Anticipated Drug Associated Adverse Events	14.8; 0.0	1.0

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01786967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.