About this trial
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 criteria
Qualifiers
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
Disqualifiers
Prior clinician diagnosis of dementia, or a Montreal Cognitive Assessment (MOCA) score of 17 or lower on screening cognitive evaluation
Current use of anticholinergic, beta-3-adrenergic agonist, or other medication designed to improve urgency incontinence symptoms, or use in the past 1 month
Initiation, discontinuation, or dose change of dementia medications (such as donepezil, galantamine, memantine, rivastigmine) in the past 1 month (but candidates on stable doses are eligible)
Initiation, discontinuation, or dose change of other drugs with strong anticholinergic effects (based on the Beers List) in the past 1 month (but candidates on stable doses are eligible)
Trial design
Treatments tested in this trial
- Tolterodine Tartrate ER
- Mirabegron
- Placebo
Treatment groups
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
National Institute on Aging (NIA)
Collaborator