Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH

NCT07829029 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2K24AG068601
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nocturia

Outcome Measures

Primary Outcomes (1)

• Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.

  Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.

  Baseline to 6 months

Secondary Outcomes (7)

• Change in nocturnal urinary incontinence frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.

  Baseline to 6 months

• Change in global sleep quality score over 6 months (24 weeks) of treatment.

  Baseline to 6 months

• Change in daytime sleepiness score over 6 months (24 weeks) of treatment.

  Baseline to 6 months

• Change in sleep efficiency over 6 months (24 weeks) of treatment, based on the PSQI sleep efficiency score.

  Baseline to 6 months

• Change in depression symptoms over 6 months (24 weeks) of treatment.

  Baseline to 6 months

Study Arms (3)

Anticholinergic bladder medication plusbehavioral self-management education

ACTIVE COMPARATOR

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

Beta-3-adrenergic agonist medication plusbehavioral self-management education

ACTIVE COMPARATOR

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

Placebo medication plus behavioral self-management education

PLACEBO COMPARATOR

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

Interventions

TolterodineTartrate ER DRUG

Anticholinergic

Anticholinergic bladder medication plusbehavioral self-management education

Mirabegron DRUG

Beta-3-adrenergic agonist

Beta-3-adrenergic agonist medication plusbehavioral self-management education

Placebo DRUG

matching placebo pill

Placebo medication plus behavioral self-management education

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Nocturia

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison Huang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Huang, MD, MAS, MPhil

CONTACT

(415) 514-8697; alison.huang@ucsf.edu

Ann Chang

CONTACT

ann.chang@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 4, 2022
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 2, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)