Recruiting

Observational StudyTReating Incontinence for Underlying Mental and Physical Health

Sponsor:

UCLA

Code:

NCT05362292

Conditions

Urinary Incontinence, Urge

Urinary Incontinence

Overactive Bladder

Incontinence, Urge

Incontinence, Urinary

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Accepted

Interventions

Tolterodine Tartrate ER

Mirabegron

Placebo

Study Details

Brief 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.

Conditions

Urinary Incontinence, Urge

Urinary Incontinence

Overactive Bladder

Incontinence, Urge

Incontinence, Urinary

Study ID

NCT05362292

Start date

Oct 4, 2022

Status verified date

Mar, 2026

Completion date

Aug 2, 2027

Anticipated

Primary completion date

May 2, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Accepted

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
Self-reported history of gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon as contraindications for anticholinergic bladder therapy
Use of drugs with adverse interactions with one of the study medications in the past 1 month, including potent CYP3A4 inhibitors, hepatic enzyme metabolism inducers, narrow therapeutic index drugs metabolized by CYP2D6, or intention to start taking one of these medications during the study treatment period
History of bladder surgery, invasive intra-vesical therapy, or bulk bladder injections in the past 3 months (more remote surgery will not be exclusionary), or intention to undergo one of these procedures in the study treatment period
Use of other specialized incontinence therapy (electrostimulation, pelvic physiotherapy, formal behavioral therapy overseen by certified practitioners) in the past 3 months (more remote therapy will not be exclusionary), or intention to undergo one of these procedures in the study treatment period
Inability to sign informed consent or complete questionnaires, interviews, or study testing in English
Other condition that would prevent the participant from completing study procedures, in the opinion of the investigators (e.g., uncontrolled psychosis)

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Anticholinergic bladder medication plus behavioral self-management education

Tolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.

active comparator: Beta-3-adrenergic agonist medication plus behavioral self-management education

Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.

placebo comparator: Placebo medication plus behavioral self-management education

Microcrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.

Interventions

Tolterodine Tartrate ER

Anticholinergic

Mirabegron

Beta-3-adrenergic agonist

Placebo

matching placebo pill

Primary outcome measure

Change in composite cognitive function over 6 months (24 weeks) of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests. [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Alison Huang, MD, MAS, MPhil

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

Ann Chang

ann.chang@ucsf.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Leslee Subak, MD

650-723-5533 lsubak@stanford.edu

University of California San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Alison Huang, MD, MAS, MPhil

alison.huang@ucsf.edu

Claudia Vila Manes

415-885-7547 claudia.vilamanes@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-06.