TReating Incontinence for Underlying Mental and Physical Health

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age60+
SponsorUniversity of California, San Francisco

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

270 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

National Institute on Aging (NIA)

Collaborator