Comparative effectiveness of pelvic floor muscle training, Mirabegron, and Trospium among older women with urgency urinary incontinence and high fall risk: a feasibility randomized clinical study.

摘要 未经治疗的尿急和尿失禁会导致身体活动减少的恶性循环， 社交孤立害怕摔倒和福尔斯。频繁排尿的冲动也会限制身体活动-关注 发现自己离浴室太远可能是呆在家里的强大动力。结构化 行为干预或药物治疗是常见的初始治疗选择。但它们会引发 通过非常不同的作用机制，可能会不同地影响与跌倒相关的结果。是的， 然而，严重缺乏关于非药理学和药理学的直接头对头试验证据， 紧急性尿失禁（UUI）的治疗，特别是在同时存在跌倒风险的女性中。拟议 可行性初步研究是一项随机、多组、混合方法的临床试验，比较了目前使用的三种方法。 老年妇女的初步治疗选择：i）12周结构化的行为为基础的盆底肌肉 培训（PFMT）干预管理的物理治疗师在诊所; ii）一个为期12周的课程的β-3 激动剂Mirabegron;和iii）12周疗程的抗毒蕈碱剂曲司氯铵， 患有UUI或膀胱过度活动症（OAB）的老年人，他们也对跌倒风险增加进行了筛查。米拉贝隆 和曲司铵与认知的纵向效应无关， 最近，一些中介机构联系在一起。我们的具体目标是：1）在临床环境中进行试点研究， 确定入组UUI或OAB老年女性的可行性，这些女性在三臂治疗中有高跌倒风险。 (PFMT与米拉贝隆与曲司铵），随机比较有效性试验; 2）描述结局 三种干预措施;和3）Qualitiment探索影响非 这些患者的药理学和药理学治疗经验。48名门诊妇女（16 每组）65岁及以上的UUI或OAB患者以及高跌倒风险筛查阳性的患者将被随机分组 （1：1：1）三个臂中的一个。可行性将通过关于可评价性、遵守 干预措施，自然减员，不良事件，有效的招聘方法，和样本的特点。我们 还将测量症状严重程度、生活质量、身体活动、福尔斯和对疾病的恐惧等重要指标。 下降基于我们的初步工作，跌倒风险将由疾病控制中心确定， 预防（CDC），停止老年人事故，死亡和伤害（STEADI）跌倒风险筛查工具。的 一项拟议的研究是第一次比较UUI和OAB在高空坠落中的这些常见非手术治疗方法。 风险患者人群，并将奠定基础的研究计划，调查双向 这两种常见的老年综合征之间存在的关系， 和对治疗的反应。

ABSTRACT Untreated, urinary urgency and incontinence can precipitate a vicious cycle of decreasing physical activity, social isolation, fear-of-falling, and falls. The urge to urinate frequently can also limit physical activity - concern for finding oneself too far from a bathroom can be a powerful motivator for just staying home. Structured behavioral interventions or medications are common initial treatment options. But they elicit their effects through very different mechanisms of action that may influence fall related outcomes differently. There is, however, a critical lack of direct head-to-head trial evidence on non-pharmacologic and pharmacologic treatments for urgency urinary incontinence (UUI), particularly in women with co-existing fall risk. The proposed feasibility pilot study is a randomized, multi-arm, mixed methods, clinical trial comparing three currently in use initial treatment options for older women: i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride, in women 65 and older with UUI or overactive bladder (OAB) who also screen positive for increased risk of falling. Mirabegron and Trospium are not associated with longitudinal effects on cognition that the traditionally used anticholinergic mediations have recently been linked to. Our Specific Aims are 1) Conduct a pilot study in clinical settings to determine the feasibility of enrolling older women with UUI or OAB who are at high risk of falling in a three-arm (PFMT, vs. mirabegron vs. Trospium), randomized comparative effectiveness trial; 2) Characterize outcomes across the three interventions; and 3) Qualitatively explore perceived factors influencing the non- pharmacologic and pharmacologic treatment experience in these patients. Forty-eight ambulatory women (16 per arm) 65 years and older with UUI or OAB and who screen positive for high fall risk will be randomized (1:1:1) to one of three arms. Feasibility will be determined through key milestones on evaluability, adherence to the interventions, attrition, adverse events, productive recruitment methods, and sample characteristics. We will also measure important indicators of symptom severity, quality of life, physical activity, falls, and fear of falling. Building upon our preliminary work, fall risk will be determined by the Centers for Disease Control and Prevention (CDC), Stopping Elderly Accidents, Deaths, and Injuries (STEADI) fall risk screening tool. The proposed study is the first to compare these common non-surgical treatments for UUI and OAB in a high fall risk patient population and will lay the groundwork for a program of research investigating the bidirectional relationships that exist across these two common geriatric syndromes both at the level of shared risk factors and responses to treatment.