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.

盆底肌肉训练、米拉贝隆和曲司氯胺对患有急迫性尿失禁和高跌倒风险的老年女性的效果比较：一项可行性随机临床研究。

• 批准号: 10648299
• 负责人: Steven R Fisher
• 金额: $ 23.32万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10648299
• 关键词: Accidents; Adherence; Adverse event; Agonist; Anti-Cholinergics; Behavior Therapy; Behavioral; Centers for Disease Control and Prevention (U.S.); Cessation of life; Characteristics; Chlorides; Clinic; Clinical; Clinical Research; Clinical Trials; Cognition; Data; Decision Making; Development; Educational Intervention; Effectiveness of Interventions; Elderly; Enrollment; Equipoise; Evaluable Disease; Failure; Geriatrics; Head; High Risk Woman; Home; Impairment; Incontinence; Individual; Intervention; Interview; Link; Literature; Measures; Mediation; Medical; Methods; Muscarinics; Outcome; Overactive Bladder; Participant; Patients; Pelvic Floor Muscle; Pharmaceutical Preparations; Pharmacological Treatment; Physical Function; Physical activity; Physicians; Pilot Projects; Prevalence; Productivity; Quality of life; Randomized; Research; Research Design; Risk Factors; Sampling; Screening procedure; Severities; Social isolation; Stigmatization; Structure; Symptoms; Syndrome; Texas; Theoretical model; Titrations; Training; Treatment Cost; Universities; Urinary Incontinence; Variant; Visit; Woman; Work; arm; care seeking; cholinergic; clinical efficacy; comparative; comparative effectiveness; comparative effectiveness trial; comparative efficacy; design; experience; fall injury; fall risk; falls; fear of falling; high risk; micturition urgency; multiple chronic conditions; older women; patient population; pharmacologic; physical therapist; primary outcome; programs; randomized effectiveness trial; recruit; risk sharing; side effect; success; treatment response; treatment risk; trial comparing; urinary

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.

抽象的 如果不及时治疗，尿急和尿失禁会导致体力活动减少的恶性循环， 社会孤立、害怕跌倒和跌倒。频繁小便的冲动也会限制身体活动——令人担忧 因为发现自己离浴室太远可能是呆在家里的强大动力。结构化 行为干预或药物是常见的初始治疗选择。但它们会产生效果 通过非常不同的行动机制，可能会以不同的方式影响跌倒相关的结果。有， 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 紧急尿失禁（UUI）的治疗，特别是对于同时存在跌倒风险的女性。拟议的 可行性试点研究是一项随机、多臂、混合方法的临床试验，比较目前使用的三种方法 老年女性的初始治疗选择： i) 为期 12 周的基于行为的结构化骨盆底肌肉治疗 由物理治疗师在诊所进行的培训（PFMT）干预； ii) 为期 12 周的 beta-3 课程 激动剂，米拉贝隆； iii) 对女性 65 进行为期 12 周的抗毒蕈碱药物 Trospium Chloride 疗程 患有 UUI 或膀胱过度活动症 (OAB) 的老年人，其跌倒风险增加的筛查结果也呈阳性。米拉贝隆 和 Trospium 与传统使用的抗胆碱能药物的认知纵向效应无关。 最近与调解相关。我们的具体目标是 1) 在临床环境中进行试点研究 确定招募患有 UUI 或 OAB 且跌倒风险较高的三臂老年女性的可行性 （PFMT、米拉贝隆与 Trospium）、随机比较有效性试验； 2) 描述结果 跨越三项干预措施； 3) 定性探索影响非非因素的感知因素 这些患者的药理学和药物治疗经验。四十八名流动妇女（16 每只手臂）65 岁及以上患有 UUI 或 OAB 且高跌倒风险筛查呈阳性的人将被随机分组 (1:1:1) 到三个手臂之一。可行性将通过可评估性、遵守的关键里程碑来确定 干预措施、人员流失、不良事件、生产性招聘方法和样本特征。我们 还将测量症状严重程度、生活质量、体力活动、跌倒和恐惧的重要指标 坠落。根据我们的初步工作，跌倒风险将由疾病控制中心和 预防 (CDC)、阻止老年事故、死亡和受伤 (STEADI) 跌倒风险筛查工具。这 拟议的研究首次比较了高跌倒时 UUI 和 OAB 的常见非手术治疗方法 风险患者群体，并将为调查双向的研究计划奠定基础 这两种常见老年综合症在共同危险因素层面上存在的关系 以及对治疗的反应。