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TReating Incontinence for Underlying Mental and Physical Health | Clinical Trials | Clareo Health

RECRUITINGPHASE4

TReating Incontinence for Underlying Mental and Physical Health

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

NCT05362292•University of California, San Francisco

View on ClinicalTrials.gov

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

Age

60 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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)
•Initiation, discontinuation, or dose change of other drugs that can affect urinary frequency, including diuretics, in the past 1 month (but candidates on stable doses are eligible)
•Current urinary tract infection (UTI) based on screening urinalysis and culture (but candidates can re-present for re-screening after undergoing treatment for UTI)
•History of allergy or sensitivity to either of the study medications or an ingredient in the placebo or study medication capsule
•Severe hepatic impairment (Child-Pugh score B or greater) or renal impairment (creatinine clearance \<30 mL/min) as a contraindication to both study medications
•Current bladder obstruction or urinary retention (defined by symptoms suggesting difficulty emptying the bladder in addition to postvoid residual urine volume greater than 150 cc by portable bladder ultrasound)
•Uncontrolled hypertension (based on measured systolic blood pressure greater than 180 or diastolic blood pressure greater than 110 mmHg) as a contraindication to beta-3-adrenergic therapy
+6 more criteria

Locations (2)

Stanford University

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

Key Dates

Start Date

October 4, 2022

Primary Completion Date

May 2, 2027

Completion Date

August 2, 2027

Last Updated

March 6, 2026

Enrollment

270

ESTIMATED participants

Conditions

Urinary Incontinence, UrgeUrinary IncontinenceOveractive BladderIncontinence, UrgeIncontinence, UrinaryIncontinence

Interventions

Tolterodine Tartrate ER

DRUG

Mirabegron

DRUG

Placebo

DRUG

Contacts

Alison Huang, MD, MAS, MPhil

CONTACT

415-514-8697 alison.huang@ucsf.edu

Ann Chang

CONTACT

ann.chang@ucsf.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TReating Incontinence for Underlying Mental and Physical Health

Inclusion Criteria

Exclusion Criteria

INOPASE - Performance and Safety Study of a Personalised SNM System

Efficacy of a Video-Based Educational Program on Female Urinary Incontinence

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Muscle Fiber Fragment Treatment for Urinary Incontinence

Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

Training for Urinary Leakage Improvement After Pregnancy