IMPROVING OUTCOMES IN GERIATRIC URINARY URGE INCONTINENCE

改善老年急迫性尿失禁的治疗效果

• 批准号: 3726494
• 负责人: NEIL M RESNICK
• 金额: --
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3726494
• 关键词: biomechanics; clinical trials; data collection methodology /evaluation; human old age (65+); human subject; human therapy evaluation; muscle relaxants; prognosis; psychometrics; quality of life; questionnaires; urinary incontinence; urinary tract disorder chemotherapy; urination

Urinary incontinence (UI) is a major problem for the elderly, threatening the ability to live independently and engendering a $15 billion annual cost that exceeds the entire NIH budget. The most common type of geriatric UI is urge UI, which is generally associated with involuntary bladder contractions-a condition known as detrusor overactivity (DO). Yet little is known about the pathogenesis of either urge UI or DO and the relationship between them is problematic. Moreover, it remains unclear how well drug therapy works for them, in whom it works, how it works, and whether patients themselves consider the improvement significant. Based on our pilot data, we postulate that there is a bimodal response, with many patients experiencing significant improvement while an equal proportion worsen. In addition, these data suggest for the first time that clinical and physiological variables may allow prediction of outcome, and significantly, provide insight into the mechanisms of improvement. The specific aims of the proposed Intervention Development Study are to: 1) devise and validate a UI-specific quality of life measure to supplement the traditional as well as newer physiological parameters predict treatment outcome in community-dwelling elderly (controlling for placebo response); and 3) identify which parameters mediate both drug and placebo responses. To accomplish these goals we will first devise and refine a patient-based UI-related quality of life measure, and then enroll 250 urge incontinent community-dwelling elderly in a randomized controlled trial of oxybutynin. Outcome measures will include changes in incontinence frequency, urodynamic parameters, and the new outcome tool. By devising a patient-based outcome tool, evaluating newer physiological tests, identifying outcome predictors, providing insights into the mechanism(s) of treatment response, and determining estimates in community-dwelling elderly of the efficacy and failure rates of both placebo and the most commonly-used therapy for DO, the study should set the stage for a definitive randomized trial of oxybutynin and other bladder relaxants. Moreover, the physiologic insights gained should advance our understanding of the pathophysiology of urge incontinence associated with DO, thereby facilitating development of new therapeutic options essential to improving independence in older adults.

尿失禁（UI）是老年人的主要问题 独立生活并增加150亿美元成本的能力 这超出了整个NIH预算。 最常见的老年UI类型 是敦促UI，通常与非自愿膀胱有关 收缩 - 一种称为鉴断过度活动的条件（DO）。 但是很少 关于冲动UI或DO的发病机理已知 他们之间的关系是有问题的。 而且，尚不清楚如何 良好的药物治疗对他们有效，它在工作中的工作方式，以及 患者本身是否认为改善很大。 基于 我们的飞行员数据，我们假设有双峰响应，许多响应 患者经历了显着改善，而相等的比例 恶化。 此外，这些数据首次表明临床 生理变量可能可以预测结果，并且 值得注意的是，洞悉改进机制。 拟议的干预开发研究的具体目的是：1） 设计和验证特定于UI的生活质量措施来补充 传统和较新的生理参数预测治疗 社区居民老年人的结果（控制安慰剂反应）； 3）确定哪些参数介导了药物和安慰剂反应。 为了实现这些目标，我们将首先设计并完善基于患者的目标 与UI相关的生活质量度量，然后注册250 在一项氧化丁物蛋白的随机对照试验中，社区居住的老年人。 结果指标将包括尿失禁频率的变化 参数和新的结果工具。 通过设计基于患者的结果 工具，评估新的生理测试，识别结果预测因子， 提供有关治疗反应机制的见解，以及 确定社区居民老年人的疗效和 安慰剂和最常用的DO疗法的失败率， 该研究应为确定的随机试验奠定了基础 oxybutynin和其他膀胱松弛剂。 而且，生理见解 获得的应提高我们对冲动病理生理学的理解 与DO相关的尿失禁，从而促进了新的发展 治疗方案对于改善老年人独立性至关重要。