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

使用药物治疗策略治疗急迫性尿失禁的老年女性的认知、泌尿和功能轨迹行政补充

• 批准号: 10635598
• 负责人: Alison Huang
• 金额: $ 6.27万
• 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/10635598
• 关键词: Address; Administrative Supplement; Adrenergic Agents; Adverse effects; Aftercare; 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; Funding; Health care facility; Impaired cognition; Incontinence; Independent Living; Industry; Intestines; Investigation; Link; Long-Term Care; Measures; Mental Depression; Methodology; Observational Study; Outcome; Overactive Bladder; Parents; Participant; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Physical Function; Placebos; Quality of life; Randomized; Reporting; Research; Risk; Severities; Sleep; Social isolation; Symptoms; Testing; Time; Tolterodine; United States; Urge Incontinence; Urinary Incontinence; Woman; base; cognitive function; cognitive performance; cognitive testing; comorbidity; comparative; cost; design; evidence base; experience; falls; functional decline; functional outcomes; improved; micturition urgency; mild cognitive impairment; neglect; older patient; older women; 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.

项目摘要 60岁以上的五分之一妇女患有紧迫性尿失禁，这种情况与 抑郁，社会隔离，身体机能下降以及独立生活的能力丧失。目前， 最常用的紧迫性尿失禁治疗方法是抗胆碱能药物 抑制膀胱的非自愿收缩。不幸的是，多次观察研究表明 抗胆碱能膀胱疗法可能会对认知产生不利影响 诊断为老年患者的痴呆症开了这些药物。结果，人们普遍关注 服用抗胆碱能药物的年龄较大的失禁患者，希望改善其膀胱 控制可能会因认知障碍而面临更大的功能妥协风险。 但是，迄今为止，将抗胆碱能药物与痴呆症联系起来的数据源 回顾性观察分析而不是前瞻性试验。少数（和主要行业赞助） 直接评估使用抗胆碱能膀胱疗法的老年人认知功能的研究一直是 小和矮小，使用了相对不敏感的认知筛查措施，限制了它们的能力 检测有意义的认知变化。虽然是尿失禁的替代性，非抗胆碱能药物 （Beta-3-Aganist Drug Mirabegron）现已上市，很少的研究比较了这种影响 对抗胆碱能膀胱疗法的药物，没有任何药物涉及比较前瞻性 评估老年人的认知。在没有严格的认知效果的严格证据的情况下， 抗胆碱能药物继续为社区中的老年患者开处方， 包括患有已知认知障碍，阿尔茨海默氏病和相关痴呆症的人。 为了解决这个问题，我们将进行严格，前瞻性，随机研究以评估扩展 约270名年龄段的妇女的认知，尿和功能轨迹，没有痴呆症。 在基线时频繁紧迫性尿失禁，正常或轻度受损的认知功能的妇女将是 分配接受标准的抗胆碱能，β-3激动剂或没有药物治疗（安慰剂） 除了患者指导的有关尿失禁行为管理的基于证据的信息。超过 1、6和9个月，我们将比较认知，尿和其他功能和生活质量结果 与β-3激动剂疗法和安慰剂相比，抗胆碱能疗法。这项研究针对紧急 需要严格的证据来确定药物尿失禁治疗策略对两者的影响 认知障碍和尿失禁，是两个最常见（并且经常合并）的条件 使老年妇女从独立生活过渡到进入长期护理设施。