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

项目总结 每五名60岁以上的女性中就有一人患有紧迫性尿失禁，这是一种与 抑郁、社交孤立、身体功能下降和丧失独立生活能力。目前， 最常用的治疗尿失禁的药物是抗胆碱能药物，旨在 抑制膀胱的不自主收缩。不幸的是，多项观察性研究表明 抗胆碱能膀胱治疗可能会对认知产生不利影响，这是基于较高的 被诊断为痴呆症的老年患者开出了这些药物。因此，人们普遍担心 年龄较大的失禁患者服用抗胆碱能药物希望改善他们的膀胱 控制可能会使自己暴露在由于认知障碍而导致的功能损害的更大风险中。 然而，到目前为止，将抗胆碱能膀胱药物与痴呆症联系起来的数据来自 回溯性的观察分析，而不是前瞻性试验。少数人(主要是行业赞助的) 使用抗胆碱能膀胱疗法直接评估老年人认知功能的研究已经被 小个子和矮个子，使用相对不敏感的认知筛查措施，限制了他们的能力 发现认知上有意义的变化。而另一种治疗尿失禁的非抗胆碱能药物 (β-3激动剂药物米拉贝格隆)现已上市，但很少有研究比较这种药物的效果。 药物治疗与抗胆碱能膀胱治疗相比，没有一种涉及比较前瞻性 老年人的认知评估。在缺乏不利认知影响的严格证据的情况下， 抗胆碱能膀胱药物继续被广泛地开给社区中的老年患者， 包括那些已知的认知障碍、阿尔茨海默病和相关痴呆症的人。 为了解决这个问题，我们将进行一项严格的、前瞻性的随机研究，以评估扩展的 约270名既往无痴呆的老年大小便失禁女性的认知、尿路和功能轨迹。 经常出现尿失禁和认知功能正常或轻度受损的女性将被 被分配接受标准的抗胆碱能、β-3激动剂或不接受药物治疗(安慰剂)的患者 除了以病人为导向、以证据为基础的失禁行为管理信息。完毕 1、6和9个月，我们将比较认知、排尿和其他功能和生活质量的结果 抗胆碱能治疗与β-3激动剂治疗和安慰剂的比较。这项研究解决了这个紧迫的问题 需要严格的证据来确定药理性尿失禁治疗策略对两者的影响 认知障碍和大小便失禁，作为两种最常见(也经常是并存)的情况 使老年妇女从独立生活过渡到进入长期护理机构。

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.