Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 60 and up Women only

Compare two bladder medicines and placebo for urgency incontinence in older women

Official title: Ancillary Nocturnal Urinary Symptom Investigation in the TRIUMPH Trial

Run by University of California, San Francisco · NCT07829029 · Data updated 2026-11-12

This study tests whether tolterodine ER or mirabegron help with urinary and aging-related outcomes in older women with urgency-predominant incontinence, compared with placebo.

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Quick facts

PhasePhase 4
Study typeInterventional
Ages60 Years and up
SexWomen only
Enrollment270 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedOctober 4, 2022
Main results expectedMay 2, 2027
Study endsMay 2, 2027
Registry record updatedSeptember 22, 2026
Trial IDNCT07829029 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 60 or older with urgency-predominant incontinence, able to walk to the bathroom, and willing to adhere to study procedures.

Probably not a fit

Individuals with dementia or MOCA scores 17 or lower, or those recently using bladder medications, may not benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4 randomized, double-blind, three-arm trial in ambulatory women aged 60 and older with urgency-predominant urinary incontinence. Participants are assigned to tolterodine ER, mirabegron, or placebo to see how each affects cognitive function, urinary symptoms, and aging-related outcomes over the study period. Eligibility requires regular urgency-driven incontinence episodes and adequate mobility, with no dementia and no recent use of bladder medications. The trial is conducted at UCSF with collaboration from the National Institute on Aging. Results will inform whether these bladder therapies offer benefits beyond symptom relief in an older population.

Why it matters

Potential benefit: If successful, participants could experience reduced urgency and incontinence episodes and potential improvements in age-related functional outcomes.

How similar studies have gone: Prior studies have shown effectiveness of anticholinergic and beta-3 agonist therapies for urgency symptoms; this trial extends assessment to cognitive and aging-related outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • University of California San Francisco
    San Francisco, California, United States
    Recruiting

Study contacts

  • Principal investigator: Alison Huang, MD — University of California, San Francisco
  • Study coordinator: Alison Huang, MD, MAS, MPhil
  • Email: alison.huang@ucsf.edu
  • Phone: (415) 514-8697

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.