Comparing Bladder Medication Effects on Thinking, Urinary Symptoms, and Daily Function in Older Women with Urgency Incontinence
Led by University of California, San Francisco · Updated on 2026-03-06
270
Participants Needed
2
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different bladder treatments on cognitive, urinary, and other aging-related functions in ambulatory older women who have urgency-predominant urinary incontinence and normal or mildly impaired cognitive function. This randomized, double-blinded, three-arm study compares anticholinergic bladder therapy, beta-3-adrenergic agonist bladder therapy, and no bladder pharmacotherapy. The study aims to understand how these treatments affect memory, urinary symptoms, and physical abilities over time.
Participants are assigned to one of three groups one receiving tolterodine tartrate an anticholinergic medication, another receiving mirabegron a beta-3-adrenergic agonist, and a placebo group receiving microcrystalline cellulose capsules. All groups receive behavioral self-management education including written materials about timed urination, lifestyle changes, pelvic floor exercises, and urge suppression. Treatment lasts 6 months, with follow-up assessments continuing up to 9 months to monitor lasting effects.
During the study, participants will undergo various cognitive tests, urinary symptom tracking, physical performance assessments, and questionnaires on sleep quality, mood, and bowel symptoms at baseline, 6 months, and 9 months. Researchers will closely monitor changes in cognitive function, urinary incontinence episodes, physical abilities, and quality of life. The study includes safety monitoring and aims to gather comprehensive data on how these bladder treatments impact older womens overall mental and physical health over time.
CONDITIONS
Brief Title
TReating Incontinence for Underlying Mental and Physical Health
Research Team
A
Alison Huang, MD, MAS, MPhil
A
Ann Chang
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Tolterodine ER plus behavioral education
Mirabegron plus behavioral education
Placebo plus behavioral education
What it is
Extended‑release tolterodine (anticholinergic) combined with behavioral self‑management education
Mirabegron (beta‑3‑adrenergic agonist) combined with behavioral self‑management education
Placebo pill combined with behavioral self‑management education
Role in trial
One of two active randomized medication strategies being evaluated
One of two active randomized medication strategies being evaluated
Randomized control arm receiving placebo plus education
Primary use
To assess effects on cognitive function and urinary incontinence in older women with urgency‑predominant incontinence
To assess effects on cognitive function and urinary incontinence in older women with urgency‑predominant incontinence
To compare cognitive and incontinence outcomes against active medication arms
How it is given or performed
Participants take extended‑release tolterodine daily alongside behavioral self‑management education
Participants take mirabegron daily alongside behavioral self‑management education
Participants take a matched placebo pill daily alongside behavioral self‑management education
Evidence status
Efficacy in older women with urgency incontinence remains under investigation in this trial
Efficacy in older women with urgency incontinence remains under investigation in this trial
Used as control; efficacy comparison against medication arms pending trial results
Important risks
Anticholinergic medications may involve risks of cognitive impairment, particularly in older or cognitively vulnerable adults
Beta‑3‑agonists such as mirabegron may have a more favorable safety profile in older adults compared to anticholinergics
Placebo involves no pharmacologic risk beyond behavioral education
Important limitations
Potential cognitive side effects may limit use in older adults; trial specifically measures cognitive outcomes
Long‑term effects and comparative benefits in older women are being studied; evidence outside trial is limited in very elderly
Placebo arm does not offer active pharmacologic benefit; results only show contrast between medications and no‑medication plus education
Patient impact
Cannot determine yet; trial will evaluate changes in incontinence episodes and quality‑of‑life outcomes
Cannot determine yet; trial will evaluate changes in incontinence episodes and quality‑of‑life outcomes
Cannot determine yet; trial will serve as baseline comparator for symptom changes and quality‑of‑life outcomes
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 60Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
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
Urinary incontinence starting at least 3 months prior to screening
At least half of incontinence episodes occur with sudden or strong urgency
Two or more urgency incontinence episodes over a 7-day period
Willing to provide informed consent and follow study procedures throughout the study
You will not qualify if you...
Prior diagnosis of dementia or cognitive score of 17 or lower on screening
Current or recent (past 1 month) use of anticholinergic, beta-3-adrenergic, or other urgency incontinence medications
Recent (past 1 month) changes in dementia or strong anticholinergic medications unless stable doses
Recent (past 1 month) changes in drugs affecting urinary frequency unless stable doses
Current urinary tract infection at screening
Allergy or sensitivity to study medications or placebo ingredients
Severe liver or kidney impairment contraindicating study drugs
Current bladder obstruction or urinary retention
Uncontrolled high blood pressure contraindicating beta-3-adrenergic therapy
History of certain gastrointestinal, eye, or neuromuscular conditions contraindicating anticholinergic therapy
Recent (past 1 month) use of drugs interacting adversely with study medications
Recent (past 3 months) bladder surgery or invasive bladder treatments
Inability to consent or complete study tasks in English
Other conditions preventing study completion as judged by investigators
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months (24 weeks)
Participants are randomly assigned to receive either an anticholinergic bladder medication, a beta-3-adrenergic agonist medication, or placebo medication, each combined with behavioral self-management education. This includes education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
Visits scheduled throughout the 6-month treatment period
Follow-up
Duration - 3 months (12 weeks)
Participants are monitored for an additional 3 months after treatment ends to assess long-term outcomes.
Visits during the 3-month follow-up period
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women.
Alison J Huang, Louise C Walter, Kristine Yaffe...