Actively Recruiting
Led by University of California, San Francisco · Updated on 2026-03-06
270
Participants Needed
2
Research Sites
13 weeks
Total Duration
U
University of California, San Francisco
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
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 women's overall mental and physical health over time.
CONDITIONS
TReating Incontinence for Underlying Mental and Physical Health
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 2 locations
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
A
Alison Huang, MD, MAS, MPhil
A
Ann Chang
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Alison J Huang, Louise C Walter, Kristine Yaffe...
https://pubmed.ncbi.nlm.nih.gov/37085880