University of California, San Francisco
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.
Urinary Incontinence, Urge
Urinary Incontinence
Overactive Bladder
Incontinence, Urge
Incontinence, Urinary
Incontinence
Tolterodine Tartrate ER
Mirabegron
Placebo
Phase 4
Study Type : | Interventional |
Estimated Enrollment : | 270 participants |
Masking : | Triple |
Primary Purpose : | Treatment |
Official Title : | Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence |
Actual Study Start Date : | October 4, 2022 |
Estimated Primary Completion Date : | September 28, 2026 |
Estimated Study Completion Date : | December 28, 2026 |
Arm | Intervention/treatment |
---|---|
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. |
Drug: Tolterodine Tartrate ER |
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. |
Drug: Mirabegron |
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. |
Drug: Placebo |
Ages Eligible for Study: | 60 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Stanford University
Palo Alto, California, United States, 94305
Recruiting
University of California San Francisco
San Francisco, California, United States, 94115