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

使用药物治疗策略治疗急迫性尿失禁的老年女性的认知、泌尿和功能轨迹

• 批准号: 10563201
• 负责人: Alison Huang
• 金额: $ 90万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-15 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10563201
• 关键词: Acceleration; Address; Adrenergic Agents; Adverse effects; Age; Agonist; Alzheimer' s disease related dementia; Anti-Cholinergics; Behavioral; Bladder; Bladder Control; Chronic; Cognition; Cognitive; Communities; Confusion; Counseling; Data; Decision Making; Dementia; Detection; Diagnosis; Double-blind trial; Drug Prescriptions; Elderly; Equilibrium; Evaluation; Fracture; Frequencies; Health care facility; Impaired cognition; Incontinence; Independent Living; Industry; Intestines; Investigation; Link; Long-Term Care; Measures; Mental Depression; Methodology; Observational Study; Outcome; Overactive Bladder; Participant; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Physical Function; Placebos; Quality of life; Randomized; Reporting; Research; Risk; Severities; Sleep; Social isolation; Symptoms; System; Testing; Tolterodine; United States; Urinary Incontinence; Woman; cognitive function; cognitive performance; cognitive testing; comorbidity; comparative; design; evidence base; experience; falls; functional decline; functional outcomes; improved; improvement on sleep; micturition urgency; mild cognitive impairment; neglect; older patient; older women; pharmacologic; preservation; prospective; psychologic; screening; treatment effect; treatment strategy; trend; urinary

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.

项目概要 五分之一的 60 岁以上女性患有急迫性尿失禁，这是一种与 目前，抑郁症、社交孤立、身体机能下降、丧失独立生活能力。 急迫性尿失禁最常用的治疗方法是抗胆碱能药物 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，因为其发生率较高 诊断出的老年痴呆症患者会服用这些药物，因此引起了广泛的关注。 服用抗胆碱能药物以期改善膀胱的老年失禁患者 由于认知障碍，控制可能会使自己面临更大的功能损害风险。 然而，迄今为止，将抗胆碱能膀胱药物与痴呆症联系起来的数据来自 回顾性观察分析而不是前瞻性试验。少数（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 又小又短，并且使用了相对不敏感的认知筛查措施，限制了他们的能力 检测有意义的认知变化，同时使用替代的非抗胆碱能药物治疗失禁。 （β-3 激动剂药物米拉贝隆）现已上市，但很少有研究比较其效果 药物治疗与抗胆碱能膀胱治疗相比，没有一个相对涉及前瞻性 在缺乏不良认知影响的严格证据的情况下，对老年人的认知进行评估。 抗胆碱能膀胱药物继续广泛用于社区老年患者， 包括已知患有认知障碍、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、随机的研究来评估长期的 大约 270 名先前没有痴呆的老年失禁女性的认知、泌尿和功能轨迹。 经常出现急迫性尿失禁且基线时认知功能正常或轻度受损的女性将接受 被分配接受标准抗胆碱能药物、β-3激动剂或不接受药物治疗（安慰剂） 除了有关失禁行为管理的以患者为导向的、基于证据的信息。 第 1、6 和 9 个月时，我们将比较受试者的认知、泌尿和其他功能和生活质量结果 抗胆碱能治疗与 β-3 激动剂治疗和安慰剂相比，这项研究解决了紧迫的问题。 需要严格的证据来确定药物性失禁治疗策略对两者的影响 认知障碍和失禁是两种最常见（且经常合并）的疾病 导致老年妇女从独立生活过渡到进入长期护理机构。