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

规划小组会议 BMP 治疗老年女性失禁的随机对照试验

基本信息

项目摘要

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.
尿失禁(UI)影响美国三分之一以上的成年女性,每年花费高达160亿至320亿美元,并显著导致老年女性的依赖性,社会孤立和抑郁症。行为矫正程序(BMP)的个体化教学被认为是UI的标准治疗方法之一,但对患者和提供者来说成本高且耗时。行为矫正计划(GST-BMP)的小组会议教学具有很大的潜力,可以为来自所有地理和社会经济阶层的更大群体的妇女提供有效的UI预防和治疗。我们对GST-BMP的初步研究表明,不仅能够有效地传授给其他教师,而且GST-BMP在治疗55岁以下的成人非卧床女性尿失禁方面也有效。在我们的初步研究中,治疗组配对分析显示排尿频率、咳嗽试验中的泄漏直径以及阴道指压、位移和持续时间评分在统计学和临床上显著改善。总体而言,与对照组(16.7%)相比,治疗组(52.2%)的UI症状严重程度在统计学上显著降低,p=0.025。鉴于UI问题的严重性,有必要扩大这项初步工作,以评估长期的临床和经济结果的GST-BMP,并测试是否在我们的试点研究中取得的成果可以复制的其他供应商在美国各地的中心。如果是这样的话,这可能会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有限的弱势群体更方便,更具成本效益。因此,我们正在寻求计划拨款支持,以开发一项III期多中心随机对照试验,测试GST-BMP与个体化BMP相比的临床和经济结果。根据这项计划拨款,我们将组建一个多学科专家团队,包括泌尿外科、泌尿妇科、泌尿外科护理、老年泌尿外科、老年医学、行为科学、卫生经济学和成果研究。该团队的主要目标是准备一项III期随机临床试验,以便在该计划拨款结束后进行多中心实施。我们将制定一份详细的程序手册(MOP),并准备和提交给国家老龄化研究所(NIA)一份由研究人员发起的研究计划,使用R 01机制和临床试验方法来验证两个假设:1)GST-BMP在临床上治疗应激、冲动和混合性UI与个体化BMP一样有效;与个体化BMP相比,GST-BMP在治疗应激性、急迫性和混合性UI方面具有成本效益。

项目成果

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ANANIAS C DIOKNO其他文献

ANANIAS C DIOKNO的其他文献

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{{ truncateString('ANANIAS C DIOKNO', 18)}}的其他基金

First Congress of Urologic Research and Education on Aging UnderActive Bladder
第一届泌尿外科研究和老年膀胱活动不足教育大会
  • 批准号:
    8652108
  • 财政年份:
    2014
  • 资助金额:
    $ 12.3万
  • 项目类别:
Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
预测老年女性尿失禁的尿失禁指数
  • 批准号:
    8525294
  • 财政年份:
    2011
  • 资助金额:
    $ 12.3万
  • 项目类别:
Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
预测老年女性尿失禁的尿失禁指数
  • 批准号:
    8328644
  • 财政年份:
    2011
  • 资助金额:
    $ 12.3万
  • 项目类别:
Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
预测老年女性尿失禁的尿失禁指数
  • 批准号:
    8524086
  • 财政年份:
    2011
  • 资助金额:
    $ 12.3万
  • 项目类别:
Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
预测老年女性尿失禁的尿失禁指数
  • 批准号:
    8237238
  • 财政年份:
    2011
  • 资助金额:
    $ 12.3万
  • 项目类别:
BEAUMONT/DETROIT CONTINENCE TREATMENT CENTER
博蒙特/底特律失禁治疗中心
  • 批准号:
    6665260
  • 财政年份:
    2000
  • 资助金额:
    $ 12.3万
  • 项目类别:
BEAUMONT/DETROIT CONTINENCE TREATMENT CENTER
博蒙特/底特律失禁治疗中心
  • 批准号:
    7251658
  • 财政年份:
    2000
  • 资助金额:
    $ 12.3万
  • 项目类别:
BEAUMONT/DETROIT CONTINENCE TREATMENT CENTER
博蒙特/底特律失禁治疗中心
  • 批准号:
    6799614
  • 财政年份:
    2000
  • 资助金额:
    $ 12.3万
  • 项目类别:
BEAUMONT/DETROIT CONTINENCE TREATMENT CENTER
博蒙特/底特律失禁治疗中心
  • 批准号:
    6517810
  • 财政年份:
    2000
  • 资助金额:
    $ 12.3万
  • 项目类别:
BEAUMONT/DETROIT CONTINENCE TREATMENT CENTER
博蒙特/底特律失禁治疗中心
  • 批准号:
    7092332
  • 财政年份:
    2000
  • 资助金额:
    $ 12.3万
  • 项目类别:

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