The FIRSTT Trial: Assessing Outcomes of Minimally Invasive Leiomyoma Therapies

描述（由申请人提供）：子宫平滑肌瘤（肌瘤或肌瘤）在四分之一的女性和高达75%的黑人女性中被诊断出来。每年由平滑肌瘤引起的直接医疗费用超过21亿美元。然而，我们的工作和其他人的工作报告，间接费用（残疾和缺勤）是子宫肌瘤妇女总费用的很大一部分。从社会角度解决临床显著子宫肌瘤的症状和控制医疗费用都是重要的目标。尽管这种疾病的发病率和发病率很高，治疗费用也很高，但缺乏指导治疗的证据。两种经fda批准的微创技术可以治疗各种大小和位置的平滑肌瘤：子宫动脉栓塞（UAE）和mri引导的聚焦超声手术（MRgFUS）。然而，它们在治疗方法、作用机制和副作用方面存在显著差异，从未被直接比较过。因此，我们建议进行第一项试验：肌瘤干预：减轻今天和明天的症状)，这是一项随机临床试验，对220名有症状的子宫平滑肌瘤妇女进行UAE或MRgFUS治疗，并随访3年。通过梅奥诊所罗切斯特和杜克大学的招募，将实现一个种族多样化的受试者队列。该试验旨在比较短期和长期结果、不良事件、结果预测因素以及每种治疗的成本。该项目的具体目标是：1)报告阿联酋和MRgFUS后的综合结果和结果预测因素。2)定量比较UAE和MRgFUS对卵巢的损害。3)从美国社会角度对阿联酋和MRgFUS治疗进行经济分析。

DESCRIPTION (provided by applicant): Uterine leiomyomas (fibroids or myomas) are diagnosed in one-fourth of all women and up to 75 % of black women. The direct health care costs attributable to leiomyomas exceed $2.1 billion annually. However, our work and that of others, report that indirect costs (disability and absenteeism) are a large part of total costs for women with uterine fibroids. Addressing the symptoms of clinically significant uterine fibroids and controlling health care costs from a societal perspective are both important goals. Despite the prevalence and morbidity of this disease and the significant costs of treatment, there is a dearth of evidence to guide therapy. Two minimally-invasive FDA-approved techniques treat leiomyomas in a wide variety of sizes and locations: uterine artery embolization (UAE) and MRI-guided focused ultrasound surgery (MRgFUS). However, they differ significantly in approach, mechanism of action and side effects and they have never been directly compared. We therefore propose the FIRSTT trial: Fibroid Interventions: Reducing Symptoms Today and Tomorrow), a randomized clinical trial treating 220 women with symptomatic uterine leiomyomas with UAE or MRgFUS and following them for three years. A racially diverse cohort of subjects will be achieved by recruiting through Mayo Clinic Rochester and Duke University. This trial is powered to compare short- and long-term outcomes, adverse events, predictors of outcome, and costs of each treatment. The specific aims of this project are: 1) To report comprehensive outcomes and predictors of outcome following UAE and MRgFUS. 2) To quantitate and compare the ovarian impairment following UAE and MRgFUS. 3) To produce an economic analysis of UAE and MRgFUS treatment from a U.S. societal perspective. PUBLIC HEALTH RELEVANCE: Uterine leiomyomas or fibroids are found in one-fourth of all women and up to three-fourths of black women. Fibroids are the leading cause of hysterectomy and account for health care costs over $2.1 billion annually. This study proposes to study the outcomes and limitations of two widely used alternatives to hysterectomy for fibroids: uterine artery embolization (UAE) and magnetic resonance imaging guided focused ultrasound surgery (MRgFUS).