Planning a RCT of Group-Session BMP to Treat Older Adult Women with Incontinence

描述（由申请人提供）：尿失禁（UI）在美国影响超过三分之一的成年女性，每年花费高达160亿至320亿美元，并严重影响老年妇女的依赖性、社会孤立和抑郁症。行为矫正项目的个体化教学被认为是治疗UI的标准治疗方法之一，但对患者和提供者来说成本高、耗时长。行为矫正计划的小组会议教学（GST-BMP）具有巨大的潜力，可以为来自所有地理和社会经济阶层的更大的妇女群体提供有效的UI预防和治疗。我们对GST-BMP的初步研究表明，GST-BMP不仅能够有效地传授给其他教师，而且对于55岁以上的成年流动女性的尿失禁治疗也很有效。在我们的初步研究中，治疗组的配对分析显示，在统计学和临床上，排尿频率、咳嗽试验漏径、阴道指压、位移和持续时间评分均有显著改善。总体而言，治疗组患者尿失禁症状严重程度（52.2%）明显低于对照组（16.7%），p=0.025。考虑到UI问题的严重性，有必要扩大这项初步工作，以评估GST-BMP的长期临床和经济结果，并测试我们在试点研究中取得的结果是否可以被美国其他中心的提供者复制。如果是这样，这可能导致广泛实施以社区为基础的方案，这些方案可能对获得医疗保健服务的机会有限的弱势群体更方便和更具成本效益。因此，我们正在寻求计划拨款支持，以开展一项III期多中心随机对照试验，测试GST-BMP与个体化BMP的临床和经济效果。在这项计划资助下，我们将组建一个由泌尿外科、泌尿妇科、泌尿外科护理、老年泌尿外科、老年医学、行为科学、卫生经济学和结果研究专家组成的多学科团队。该团队的主要目标是准备一项III期随机临床试验，准备在计划拨款结束后进行多地点实施。我们将开发一份详细的程序手册（MOP），并准备并向国家老龄化研究所（NIA）提交一份由研究者发起的研究计划，使用R01机制和临床试验方法来检验两个假设：1)GST-BMP在治疗压力、冲动和混合性UI方面与个体化BMP在临床上同样有效；2)与个体化BMP相比，GST-BMP在治疗应激、冲动和混合性UI方面具有成本效益。

DESCRIPTION (provided by applicant): Urinary incontinence (UI) affects more than one in three adult women in the United States, costs as much as $16 to $32 billion yearly, and contributes significantly to dependency, social isolation, and depression in older women. Individualized teaching of behavior modification program (BMP) is known as one of the standard treatments for UI but is costly and time consuming for patients and providers. Group-Session Teaching of a Behavioral Modification Program (GST-BMP) has significant potential to deliver effective UI prevention and treatment to larger groups of women from all geographic and socioeconomic strata. Our preliminary studies of GST-BMP have demonstrated that not only is the ability to teach effectively transferable to other instructors but GST-BMP is also effective in treating incontinence in adult ambulatory women =55 years old. Treatment group paired analysis in our pilot study showed statistically and clinically significant improvements in voiding frequency, leak diameter in cough test, and vaginal digital pressure, displacement, and duration scores. Overall, UI symptom severity was statistically significantly reduced among the treatment group (52.2%) compared to the control group (16.7%), p=0.025. Given the magnitude of the problem of UI, there is a need to expand this preliminary work to evaluate long-term clinical and economic outcomes of GST-BMP, and to test whether outcomes achieved in our pilot study can be replicated by other providers at centers throughout the US. If so, this could lead to widespread implementation of community-based programs that may be more convenient and cost-effective for vulnerable populations with limited access to health care services. Therefore, we are seeking planning grant support to develop a Phase III multi-center randomized control trial testing the clinical and economic outcomes of GST-BMP compared to individualized BMP. Under this planning grant we will assemble a multidisciplinary team of experts in urology, urogynecology, urology nursing, geriatric urology, geriatric medicine, behavioral science, health economics, and outcomes research. The major goal of this team is to prepare a Phase III randomized clinical trial ready for multi-site implementation upon conclusion of this planning grant. We will develop a detailed Manual of Procedures (MOP) and prepare and submit to the National Institute on Aging (NIA) an investigator-initiated research proposal using an R01 mechanism and a clinical trial methodology to test two hypotheses: 1) GST-BMP is clinically as effective in the treatment of stress, urge, and mixed UI as individualized BMP; and 2) GST-BMP is cost-effective compared to individualized BMP in treating stress, urge, and mixed UI.