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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
First received: February 4, 2013
Last updated: May 27, 2015
Last verified: May 2015
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

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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
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 ClinicalTrials.gov identifier: NCT01786967

Contact: Betty Rupp, MPH 919-843-8114 brupp@med.unc.edu

United States, North Carolina
UNC-Chapel Hill, Dept of Ob/Gyn Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Betty Rupp, MPH    919-843-8114    brupp@med.unc.edu   
Principal Investigator: Jennifer M Wu, MD, MPH         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Principal Investigator: Jennifer M Wu, MD UNC-CH
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01786967     History of Changes
Other Study ID Numbers: Pro00036147, 1R03AG042335-01
Study First Received: February 4, 2013
Last Updated: May 27, 2015
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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 30, 2015