Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH

September 14, 2026 updated by: University of California, San Francisco

Ancillary Nocturnal Urinary Symptom Investigation in the TRIUMPH Trial

The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed tocompare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonistbladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinaryincontinence and either normal or mildly impaired cognitive function at baseline.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alison Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anticholinergic bladder medication plusbehavioral 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 urge suppression
Drug: TolterodineTartrate ER
Anticholinergic
Active Comparator: Beta-3-adrenergic agonist medication plusbehavioral 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.
Drug: Mirabegron
Beta-3-adrenergic agonist
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 time duration, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
Drug: Placebo
matching placebo pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.
Time Frame: Baseline to 6 months
Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The composite cognitive score will be calculated as the average of Z-scores from the following individual cognitive tests: a) Auditory Verbal Learning Test (AVLT); b) Oral Trail Making Test (OTMT) part A; c) OTMT part B; d) Digit Span Test; and e) Digit Symbol Substitution Test (DSST). The normative mean of each cognitive test will be subtracted from each participant's component test score, and this difference will be divided by the standard deviation for the appropriate normative sample. After scores from individual tests are transformed to Z scores as a common metric based on normative data, the average Z score from all available tests will be calculated to provide a composite Z score.
Baseline to 6 months
Change in nocturnal urinary incontinence frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.
Time Frame: Baseline to 6 months
Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.
Baseline to 6 months
Change in global sleep quality score over 6 months (24 weeks) of treatment.
Time Frame: Baseline to 6 months
Perceived sleep quality will be assessed using the Pittsburgh Sleep Quality Index(PSQI), an 18-item validated questionnaire designed to assess sleep quality, latency, efficiency, and problems over a one-week period.
Baseline to 6 months
Change in daytime sleepiness score over 6 months (24 weeks) of treatment.
Time Frame: Baseline to 6 months
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire assessing the level of general sleepiness during real life situationsin order to distinguish excessive daytime sleepiness from normal daytime sleepiness.
Baseline to 6 months
Change in sleep efficiency over 6 months (24 weeks) of treatment, based on the PSQI sleep efficiency score.
Time Frame: Baseline to 6 months
Sleep efficiency will be assessed based on questions 1, 3, and 4 of the Pittsburgh Sleep Quality Index (PSQI).
Baseline to 6 months
Change in depression symptoms over 6 months (24 weeks) of treatment.
Time Frame: Baseline to 6 months
Depression symptoms will be assessed using the 15-item short form of the GeriatricDepression Scale-15 (GDS-15), which assesses symptoms of depression over a 1-week period.
Baseline to 6 months
Change in anxiety symptoms over 6 months (24 weeks) of treatment.
Time Frame: Baseline to 6 months
Anxiety symptoms will be assessing using the Generalized Anxiety Disorder-7 (GAD7),7-item short form, questionnaire to assess severity of anxiety symptoms over a 2-weekperiod.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Alison Huang, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Estimated)

May 2, 2027

Study Completion (Estimated)

May 2, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2K24AG068601 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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