# Cognitive, urinary, and functional trajectories of older women using pharmacologic treatment strategies for urgency incontinence

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $900,018

## Abstract

PROJECT SUMMARY
One in five women over the age of 60 suffers from urgency incontinence, a condition associated with
depression, social isolation, physical function decline, and loss of ability to live independently. Currently, the
most commonly used treatments for urgency incontinence are anticholinergic medications designed to
suppress involuntary contractions of the bladder. Unfortunately, multiple observational studies have suggested
that anticholinergic bladder therapy may have adverse effects on cognition, based on higher rates of
diagnosed dementia in older patients prescribed these medications. As a result, there is widespread concern
that older incontinent patients who take anticholinergic medications in the hopes of improving their bladder
control may be exposing themselves to greater risk of functional compromise due to cognitive impairment.
To date, however, the data linking anticholinergic bladder medications with dementia are derived from
retrospective observational analyses rather than prospective trials. The few (and primarily industry-sponsored)
studies directly assessing cognitive function in older adults using anticholinergic bladder therapy have been
small and short and have used relatively insensitive cognitive screening measures, limiting their ability to
detect meaningful changes in cognition. While an alternate, non-anticholinergic medication for incontinence
(the beta-3-agonist drug mirabegron) is now available, very little research has compared the effects of this
medication to that of anticholinergic bladder therapy, and none has involved comparative prospective
assessments of cognition in older adults. In the absence of rigorous evidence of adverse cognitive effects,
anticholinergic bladder medications continue to be widely prescribed to older patients in the community,
including those with known cognitive impairment, Alzheimer’s disease, and related dementias.
To address this issue, we will conduct a rigorous, prospective, randomized study to evaluate extended
cognitive, urinary, and functional trajectories in ~270 older incontinent women without pre-existing dementia.
Women with frequent urgency incontinence and normal or mildly impaired cognitive function at baseline will be
assigned to receive standard anticholinergic, beta-3 agonist, or no pharmacologic treatment (placebo) in
addition to patient-directed, evidence-based information about behavioral management of incontinence. Over
1, 6, and 9 months, we will compare cognitive, urinary, and other functional and quality-of-life outcomes of
anticholinergic therapy in comparison to beta-3-agonist therapy and placebo. This research address the urgent
need for rigorous evidence to determine the effects of pharmacologic incontinence treatment strategies on both
cognitive impairment and incontinence, as two of the most common (and frequently comorbid) conditions that
cause older women to transition from living independently to entering long-term care facilities.

## Key facts

- **NIH application ID:** 10563201
- **Project number:** 5R01AG075471-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Alison Huang
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $900,018
- **Award type:** 5
- **Project period:** 2022-02-15 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10563201

## Citation

> US National Institutes of Health, RePORTER application 10563201, Cognitive, urinary, and functional trajectories of older women using pharmacologic treatment strategies for urgency incontinence (5R01AG075471-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10563201. Licensed CC0.

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