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令人痛苦、尴尬且经常未被报告的尿失禁(UI)问题。2008年国际尿失禁咨询会议的一个主要委员会得出结论，盆底肌肉训练(PFMT)应该作为所有有压力、冲动或混合性尿失禁的女性的一线治疗，而膀胱训练(BT)可能比药物治疗更受欢迎。保守治疗风险低，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计划。小组会议介绍了一系列保守的自我管理做法--PFMT、BT和诀窍手法，这是一种先发制人的收缩，以减少应激性尿失禁和/或抑制冲动尿失禁。在干预12个月后，我们发现了双重的尿失禁预防效果。此外，我们发现了高和持续的依从性：干预后3个月和12个月分别为82%和68%。在四年的随访中，早期的自我效能预测了70%的持续依从性。这种干预措施是新颖的，因为它使妇女能够采用并保持有效的膀胱健康做法来预防失禁，而迄今为止保守的治疗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的健康女性护理的一部分，但期望忙碌的临床医生在短暂的会面范围内提供这些信息是不现实的。我们已经开发了15分钟的DVD，这是预防行为会议的浓缩版本；它具有文化敏感性，并产生了类似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)，我们的目标是通过将600名55岁及以上的女性随机分成两组进行有效性比较试验，将群体行为程序的结果与DVD版本进行比较。随访时间为干预后3个月、12个月和24个月。(目标1)。控制年龄和体重指数，我们将检验假设：HO1：不同组(原发HO)之间的尿失禁发生率没有差异：HO2：干预后的自我管理依从性在H03组之间没有差异：在干预后的自我效能方面不会有差异在组之间采取策略我们将进行经济分析比较两个小时的会议和DVD版本(目标2)。如果试验假设得到证实，描述成本并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。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种适合在井下妇女护理(年度访问)点进行广泛翻译的尿失禁预防干预。

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).