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

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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.