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女性患有尿失禁（UI），这一问题令人痛苦、尴尬，但往往未被报道。2008年国际尿失禁咨询的一个关键委员会得出结论，盆底肌肉训练（PFMT）应作为所有有压力性、急迫性或混合性尿失禁的妇女的一线治疗，膀胱训练（BT）可能优于药物治疗。保守策略是低风险的，不会影响未来的治疗。我们认为这样的自我管理实践也应该预防UI，并进行了一项随机对照试验来测试预防行为程序。小组会议介绍了一系列保守的自我管理实践- PFMT， BT和Knack机动，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，我们发现了两倍的尿失禁预防效果。此外，我们发现高且持续的依从性：干预后3个月为82%，12个月为68%。在四年的随访中，早期自我效能感预测70%的持续依从性。这种干预是新颖的，因为它使妇女采取和维持有效的膀胱保健措施预防尿失禁，而迄今为止，保守的管理方法主要集中在治疗上。根据我们现在所知道的，这些做法应该是标准女性护理的一部分，但期望忙碌的临床医生在一次简短的会面中提供这些信息是不现实的。我们制作了一份15分钟的DVD，是预防行为会议的浓缩版；它具有文化敏感性，并产生了相当水平的知识和自我效能。使用两个地点（密歇根州和宾夕法尼亚州），我们的目标是通过随机选择600名55岁及以上的女性进行两组比较效果试验，将团体行为计划的结果与DVD版本进行比较。随访时间分别为干预后3个月、12个月和24个月。(目标1)。控制年龄和BMI，我们将检验假设：HO1：组间尿失速发生率无差异（PRIMARY HO）； HO2：组间干预后自我管理依从性无差异；HO3：组间干预后采取策略的自我效能感无差异。我们将对两小时的课程与DVD版本进行经济分析（目的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，如果试验假设得到证实。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依从性的可持续性（目标3）。我们的长期目标是提供一种适用于女性健康护理（年度访问）的广泛翻译的UI预防干预。

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.