TReating Incontinence for Underlying Mental and Physical Health

Part of paid clinical trials in Palo Alto, California.

Sponsor
University of California, San Francisco
Study ID
NCT05362292
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Incontinence
  • Incontinence, Urge
  • Incontinence, Urinary
  • Overactive Bladder
  • Urinary Incontinence
  • Urinary Incontinence, Urge

Eligibility Criteria

Sex
FEMALE
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tolterodine Tartrate ER — DRUG
    Anticholinergic
  • Mirabegron — DRUG
    Beta-3-adrenergic agonist
  • Placebo — DRUG
    matching placebo pill

Study Details

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.

Key Dates

Start date
Oct 4, 2022
Status verified
Mar 2026
Primary completion
May 2, 2027
Completion
Aug 2, 2027

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Leslee Subak, MD
[email protected]
650-723-5533
University of California San FranciscoSan FranciscoCalifornia94115
Alison Huang, MD, MAS, MPhil
[email protected]
Claudia Vila Manes
[email protected]
415-885-7547

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