RecruitingPhase 4NCT05362292

TReating Incontinence for Underlying Mental and Physical Health

Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence


Sponsor

University of California, San Francisco

Enrollment

270 participants

Start Date

Oct 4, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing medications to treat urgency urinary incontinence (the sudden, strong urge to urinate that leads to leaking) in older women, while also examining whether treatment improves mental health and thinking. It is open to women 60 and older. You may be eligible if... - You are a woman aged 60 or older (female sex at birth, without gender reassignment surgery or hormones) - You can walk to the bathroom and use the toilet without help - You have had urinary incontinence for at least 3 months - At least half of your leaks happen with a sudden strong urge - You have 2 or more urgency incontinence episodes per week You may NOT be eligible if... - You have been diagnosed with dementia, or you scored 17 or lower on a cognitive screening test - You currently use or recently used medications specifically for urgency incontinence - You have recently started, stopped, or changed dosages of dementia medications or other drugs that affect urination - You have a current urinary tract infection - You have a known allergy to either study medication - You have severe liver or kidney impairment - You have bladder obstruction or significant urinary retention - You have uncontrolled high blood pressure (above 180/110) - You have gastric retention, narrow-angle glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon - You cannot complete questionnaires or interviews in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTolterodine Tartrate ER

Anticholinergic

DRUGMirabegron

Beta-3-adrenergic agonist

DRUGPlacebo

matching placebo pill


Locations(2)

Stanford University

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT05362292


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