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

This study has been completed.
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill Identifier:
First received: February 4, 2013
Last updated: July 13, 2016
Last verified: July 2016
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.

Condition Intervention
Urge Urinary Incontinence
Drug: Fesoterodine Fumarate

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly

Resource links provided by NLM:

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Treatment Benefit Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To explore whether CYP2D6 metabolizer status can predict efficacy during 4 weeks of fesoterodine fumarate therapy in elderly women with UUI. All subjects will be started on fesoterodine 4mg for 2 weeks followed by 8mg for 2 weeks. The primary outcome will be patient-reported treatment response based on a 4-point scale utilized in phase III clinical trials

Enrollment: 66
Study Start Date: September 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine Fumarate Drug: Fesoterodine Fumarate
FDA approved anticholinergic medication used for treatment of urge urinary incontinence
Other Name: Toviaz

  Show Detailed Description


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 UTI 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01786967

United States, North Carolina
UNC-Chapel Hill, Dept of Ob/Gyn
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Principal Investigator: Jennifer M Wu, MD UNC-CH
  More Information

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01786967     History of Changes
Other Study ID Numbers: Pro00036147  1R03AG042335-01 
Study First Received: February 4, 2013
Last Updated: July 13, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
overactive bladder
urge urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on January 18, 2017