Actively Recruiting
TReating Incontinence for Underlying Mental and Physical Health
Led by University of California, San Francisco · Updated on 2026-03-06
270
Participants Needed
2
Research Sites
251 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
TReating Incontinence for Underlying Mental and Physical Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prior clinician diagnosis of dementia or a Montreal Cognitive Assessment (MOCA) score of 17 or lower on screening
- Current or recent (past 1 month) use of anticholinergic, beta-3-adrenergic agonist, or other urgency incontinence medications
- Recent (past 1 month) changes in dementia medications such as donepezil, galantamine, memantine, or rivastigmine unless dose is stable
- Recent (past 1 month) changes in drugs with strong anticholinergic effects or drugs affecting urinary frequency unless dose is stable
- Current urinary tract infection at screening (treatment and re-screening allowed)
- Allergy or sensitivity to study medications or placebo ingredients
- Severe liver impairment (Child-Pugh B or greater) or kidney impairment (creatinine clearance <30 mL/min)
- Current bladder obstruction or urinary retention with residual urine volume over 150 cc
- Uncontrolled high blood pressure (systolic >180 or diastolic >110 mmHg)
- History of gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon
- Use of drugs with adverse interactions with study medications in the past 1 month or intended use during study
- History of bladder surgery, invasive bladder therapy, or bulk bladder injections in the past 3 months or planned during study
- Use of specialized incontinence therapy (electrostimulation, pelvic physiotherapy, formal behavioral therapy) in past 3 months or planned during study
- Unable to provide informed consent or complete study activities in English
- Other conditions preventing study completion as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
Research Team
A
Alison Huang, MD, MAS, MPhil
CONTACT
A
Ann Chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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