Find Urinary Incontinence Clinical Trials Near You
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed to compare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonist bladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 60
Healthy Volunteers: t
View:
• Aged 60 years or older at the time of enrollment
• Female sex at birth, without surgical or hormonal gender re-assignment therapy
• Able to walk to the bathroom and use the toilet without assistance
• Report urinary incontinence starting at least 3 months prior to screening
• Report that at least half of incontinence episodes occur with a sudden or strong sensation of urgency
• Report 2 or more urgency incontinence episodes over a 7-day period
• Willing to provide informed consent and adhere to study procedures throughout the length of the study
Locations
United States
California
Stanford University
RECRUITING
Palo Alto
University of California San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Alison Huang, MD, MAS, MPhil
alison.huang@ucsf.edu
415-514-8697
Backup
Ann Chang
ann.chang@ucsf.edu
Time Frame
Start Date:2022-10-04
Estimated Completion Date:2027-08-02
Participants
Target number of participants:270
Treatments
Active_comparator: Anticholinergic bladder medication plus behavioral self-management education
Tolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
Active_comparator: Beta-3-adrenergic agonist medication plus behavioral self-management education
Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
Placebo_comparator: Placebo medication plus behavioral self-management education
Microcrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.