Translating Unique Learning for Incontinence Prevention: The TULIP Project

描述（由申请人提供）：超过三分之一的美国妇女患有令人痛苦，尴尬，往往未报告的尿失禁（UI）问题。2008年国际尿失禁咨询会的一个关键委员会得出结论，盆底肌肉训练（PFMT）应作为所有压力、冲动或混合性尿失禁妇女的一线治疗，膀胱训练（BT）可能优于药物治疗。保守策略风险低，不会影响未来的治疗。我们推断，这种自我管理的做法也应该防止UI，并进行了随机对照试验，以测试预防行为计划。小组会议提出了一系列保守的自我管理实践- PFMT，BT和Knack Maneuver，这是一种先发制人的收缩，以减少压力UI和/或抑制冲动UI。在干预后12个月，我们发现了双重UI预防效果。此外，我们发现高和持续的依从性：干预后3个月为82%，12个月为68%。在四年的随访中，早期自我效能预测持续依从性为70%。这种干预是新颖的，因为它使妇女能够采取和维持有效的膀胱健康做法，以预防尿失禁，而迄今为止，保守的管理方法集中在治疗。根据我们现在所知道的，这些做法应该是标准的妇女保健的一部分，但它是不现实的期望忙碌的临床医生提供这些信息的范围内，一个简短的遭遇。我们已经开发了一个15分钟的DVD，这是一个浓缩版的预防行为会议;它是文化敏感，并产生了可比水平的知识和自我效能。使用两个网站（密歇根州和宾夕法尼亚州），我们的目标是比较结果的群体行为计划的DVD版本随机600名妇女年龄在55岁及以上的两个武器的比较有效性试验。将在干预后3个月、12个月和24个月进行随访。(Aim 1）。控制年龄和BMI，我们将检验假设：HO 1：两组间UI发生率无差异（主要HO）HO 2：HO 3组之间的干预后自我管理依从性没有差异：干预后采用策略的自我效能在各组之间没有差异。我们将进行一项经济分析，比较两小时的课程与DVD版本（目标2）。描述成本和分析支付意愿和就业数据将是本研究的主要重点，以便为未来的成本效益分析奠定基础，应试验假设得到证实。在干预后36个月，我们将进行访谈，以了解哪些干预因素有助于坚持的可持续性（目标3）。我们的长期目标是提供一个UI预防干预适合广泛的翻译点，以及妇女护理（年度访问）。 公共卫生相关性：在美国，每三名女性中就有一名患有尿失禁的痛苦和隐藏问题，这种情况每年花费我们的经济超过190亿美元（超过乳腺癌，宫颈癌和卵巢癌的总和）。我们创新的预防计划教导女性低风险的自我管理实践，并已被证明可以将尿失禁的风险降低一半。如果作为这项研究的结果，DVD版本以更低的成本产生类似的健康结果，那么它将适合在每年的健康检查中或通过互联网提供给女性，这将使无数女性受益。

DESCRIPTION (provided by applicant): More than one in three US women suffer from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). A key committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and do not prejudice future treatments. We reasoned that such self-management practices should also prevent UI and conducted a RCT to test a prevention behavioral program. A group session presented an array of conservative self-management practices- PFMT, BT and the Knack Maneuver, which is a preemptive contraction to decrease stress UI and/or suppress urge UI. At 12-months post- intervention we found a two-fold UI prevention effect. Moreover, we found high and sustained adherence: 82% at 3 months post intervention and 68% at 12 months. At four years follow-up, sustained adherence of 70% was predicted by early self-efficacy. This intervention is novel because it enables women to adopt and sustain efficacious bladder health practices for incontinence prevention, whereas to date conservative management approaches have focused on treatment. Based on what we now know, these practices should be part of standard well woman care, but it is not realistic to expect busy clinicians to provide this information within the confines of a brief encounter. We have developed a 15-minute DVD that is a condensed version of the prevention behavioral session; it is culturally sensitive and has yielded comparable levels of knowledge and self-efficacy. Using two sites (Michigan and Pennsylvania), we aim to compare the outcomes of the group behavioral program to the DVD version by randomizing 600 women aged 55 years and older to two arms of a comparative effectiveness trial. Follow-up will be at 3-months, 12-months, and 24-months post-intervention. (Aim 1). Controlling for age and BMI, we will test the hypotheses: HO1: There will be no difference in UI incidence demonstrated between groups (PRIMARY HO) HO2: There will be no difference in post-intervention self-management adherence between groups HO3: There will be no difference in post-intervention self-efficacy to adopt strategies between groups We will conduct an economic analysis comparing the two-hour session with the DVD version (Aim 2). Describing the costs and analyzing the willingness to pay and employment data will be the primary focus of this study in order to create the foundation for a future cost-effectiveness analysis, should trial hypotheses be confirmed. At 36-months post-intervention, we will conduct interviews to learn which intervention elements contributed to sustainability of adherence (Aim 3). Our long-range objective is to provide a UI prevention intervention suitable for wide-spread translation at the point of well woman care (annual visit). PUBLIC HEALTH RELEVANCE: More than one of every three women in the United States suffers from the distressing and hidden problem of urinary incontinence, a condition that costs our economy more than $19 billion per year (greater than the combined costs of breast, cervical, and ovarian cancers). Our innovative prevention program teaches women about low-risk, self-management practices and has been shown to cut their risk of urinary incontinence in half. If, as a result of this study, the DVD version yields similar health outcomes for less cost, it would be suitable to give to women at their annual health visits or via the internet with a benefit for untold numbers of women.