The FIRSTT Trial: Assessing Outcomes of Minimally Invasive Leiomyoma Therapies

FIRSTT 试验：评估微创平滑肌瘤治疗的结果

• 批准号: 8508984
• 负责人: Elizabeth A Stewart
• 金额: $ 53.84万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8508984
• 关键词: Absenteeism; Accounting; Address; Adverse effects; Adverse event; Alternative Therapies; Arteries; Biological Assay; Clinic; Coagulative necrosis; Complementary therapies; Cost Effectiveness Analysis; Diagnosis; Direct Costs; Disease; Economics; FDA approved; Facilities and Administrative Costs; Fibroid Tumor; Focused Ultrasound Therapy; Follicle Stimulating Hormone; Goals; Health; Health Care Costs; Health Status; Hemorrhage; Hysterectomy; Impairment; Individual; Intervention; Lead; Leiomyoma; Life; Location; Magnetic Resonance Imaging; Medical; Menopause; Morbidity - disease rate; Myoma; Necrosis; Operative Surgical Procedures; Outcome; Outcome Study; Ovarian; Pain; Periodicity; Pregnancy; Prevalence; Protocols documentation; Quality of life; Randomized Clinical Trials; Recruitment Activity; Reporting; Resources; SF-36; Safety; Serum; Symptoms; Techniques; Treatment Cost; Universities; Uterine Fibroids; Uterine myomectomy; Woman; Work; clinically significant; cohort; cost; disability; improved; minimally invasive; mullerian-inhibiting hormone; myometrium; primary outcome; symptomatic improvement

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).

描述(申请人提供)：子宫肌瘤(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。每年可归因于肌瘤的直接医疗费用超过21亿美元。然而，我们和其他人的工作报告称，间接成本(残疾和旷工)是患有子宫肌瘤的女性总成本的很大一部分。解决具有临床意义的子宫肌瘤症状和从社会角度控制医疗费用都是重要的目标。尽管这种疾病的患病率和发病率很高，治疗费用也很高，但缺乏指导治疗的证据。FDA批准的两种微创技术治疗各种大小和位置的肌瘤：子宫动脉栓塞术(UAE)和MRI引导的聚焦超声手术(MRgFUS)。然而，它们在方法、作用机制和副作用方面存在显著差异，而且它们从未被直接比较过。因此，我们建议进行FIRSTT试验：肌瘤干预：减少今天和明天的症状)，这是一项随机临床试验，使用UAE或MRgFUS治疗220名患有症状性子宫肌瘤的女性，并对他们进行为期三年的跟踪调查。通过梅奥诊所、罗切斯特大学和杜克大学的招聘，将实现不同种族的学科队列。这项试验是为了比较短期和长期结果、不良事件、结果的预测因素和每种治疗的成本。该项目的具体目标是：1)报告阿联酋和MRgFUS之后的综合结果和结果预测因素。2)定量比较UAE和MRgFUS对卵巢功能的损害。3)从美国社会的角度对阿联酋和MRgFUS的待遇进行经济分析。 公共卫生相关性：子宫肌瘤或子宫肌瘤在四分之一的女性和多达四分之三的黑人女性中被发现。子宫肌瘤是子宫切除术的主要原因，每年的医疗费用超过21亿美元。本研究旨在研究子宫肌瘤切除术的两种广泛使用的替代方法：子宫动脉栓塞术(UAE)和磁共振引导下的聚焦超声手术(MRgFUS)的疗效和局限性。