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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01786967
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : October 22, 2018
Last Update Posted : December 21, 2018
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Urge Urinary Incontinence Drug: Fesoterodine Fumarate Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly
Actual Study Start Date : September 2012
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fesoterodine Fumarate
Participants will receive 4 mg of study drug for first 2 weeks, and then 8 mg of study drugs for 2 weeks.
Drug: Fesoterodine Fumarate
FDA approved anticholinergic medication used for treatment of urge urinary incontinence
Other Name: Toviaz

Primary Outcome Measures :
  1. Percentage With Treatment Success [ Time Frame: 4 weeks ]
    Treatment Success (Yes/No) was defined by the Treatment Benefit Scale (TBS). TBS is a 4-point scale which was dichotomized into Yes/No for the Treatment Success outcome. The scale asks participants to rate "My condition has been improved: 1= greatly improved, 2=improved, 3=not changed, 4= worsened." If a participant responded 1 (greatly improved) or 2 (improved), they were considered as a "Yes" for Treatment Success. If a participant responded 3 (not changed) or 4 (worsened), then they were considered as a "No" for Treatment Success.

Secondary Outcome Measures :
  1. Percentage With Moderate to Severe Anticipated Drug Associated Adverse Events [ Time Frame: 4 weeks ]
    Outcome was defined as moderate to severe anticipated adverse events (AE) based on the NCI Common Terminology Criteria for Adverse Events (CTCAE). Each AE is graded 1-5 with Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, grade 5=Death-related to AE. Any side effect grade >= 2 considered a moderate to severe AE. Anticipated AEs included dizziness, somnolence, insomnia, confusion, cognitive impairment, dry eyes, blurry vision, dry mouth, constipation, nausea, dyspepsia and urinary retention. Example: dry mouth grades per CTCAE: Grade 1=symptomatic without significant dietary alteration; unstimulated saliva flow > 0.2 mL/min; Grade 2=symptomatic and significant oral intake alteration; unstimulated saliva flow 0.1 to 0.2 mL/min; Grade 3=symptoms leading to inability to adequately aliment orally; IV fluids, tube feedings or total parenteral nutrition indicated; unstimulated saliva < 0.1 mL/min.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01786967     History of Changes
Other Study ID Numbers: 13-2066
1R03AG042335-01 ( U.S. NIH Grant/Contract )
Pro00036147 ( Other Identifier: UNC )
First Posted: February 8, 2013    Key Record Dates
Results First Posted: October 22, 2018
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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