TReating Incontinence for Underlying Mental and Physical Health
NCT05362292 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2026-03-06
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.
Conditions
- Urinary Incontinence, Urge
- Urinary Incontinence
- Overactive Bladder
- Incontinence, Urge
- Incontinence, Urinary
- Incontinence
Interventions
- DRUG
-
Tolterodine Tartrate ER
Anticholinergic
- DRUG
-
Mirabegron
Beta-3-adrenergic agonist
- DRUG
-
matching placebo pill
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Alison Huang, MD, MAS, MPhil · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-04
- Primary Completion
- 2027-05-02
- Completion
- 2027-08-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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