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

NCT01786967 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: 13-20661R03AG042335-01Pro00036147
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Urinary Incontinence

Keywords

overactive bladder; urge urinary incontinence; pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Percentage With Treatment Success

  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.

  4 weeks

Secondary Outcomes (1)

• Percentage With Moderate to Severe Anticipated Drug Associated Adverse Events

  4 weeks

Study Arms (1)

Fesoterodine Fumarate

EXPERIMENTAL

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

Interventions

Fesoterodine Fumarate DRUG

FDA approved anticholinergic medication used for treatment of urge urinary incontinence

Also known as: Toviaz

Fesoterodine Fumarate

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UNC-Chapel Hill, Dept of Ob/Gyn

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Limitations and Caveats

This is a pilot study. Given the smaller size of the study population in this pilot trial, the number of poor metabolizers is low.

Results Point of Contact

• Title: Jennifer Wu, MD, MPH
• Organization: University of North Carolina at Chapel Hill

jennifer_wu@med.unc.edu

919-966-0014

Study Officials

• Jennifer M Wu, MD

  UNC-CH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 8, 2013
• Study Start: September 1, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 18, 2020
• Results First Posted: October 22, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)