Trials / Recruiting
RecruitingNCT05362292
TReating Incontinence for Underlying Mental and Physical Health
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- Female
- Age
- 60 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Tolterodine Tartrate ER | Anticholinergic |
| DRUG | Mirabegron | Beta-3-adrenergic agonist |
| DRUG | Placebo | matching placebo pill |
Timeline
- Start date
- 2022-10-04
- Primary completion
- 2027-05-02
- Completion
- 2027-08-02
- First posted
- 2022-05-05
- Last updated
- 2026-03-06
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05362292. Inclusion in this directory is not an endorsement.