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).

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD060503-02
Application #
8117540
Study Section
Special Emphasis Panel (ZRG1-EMNR-A (50))
Program Officer
De Paolo, Louis V
Project Start
2010-08-01
Project End
2015-07-31
Budget Start
2011-08-01
Budget End
2012-07-31
Support Year
2
Fiscal Year
2011
Total Cost
$581,372
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
Laughlin-Tommaso, Shannon K; Hesley, Gina K; Hopkins, Matthew R et al. (2017) Clinical limitations of the International Federation of Gynecology and Obstetrics (FIGO) classification of uterine fibroids. Int J Gynaecol Obstet 139:143-148
Borah, Bijan J; Yao, Xiaoxi; Laughlin-Tommaso, Shannon K et al. (2017) Comparative Effectiveness of Uterine Leiomyoma Procedures Using a Large Insurance Claims Database. Obstet Gynecol 130:1047-1056
Laughlin-Tommaso, Shannon K; Khan, Zaraq; Weaver, Amy L et al. (2017) Cardiovascular and metabolic morbidity after hysterectomy with ovarian conservation: a cohort study. Menopause :
Barnard, Emily P; AbdElmagied, Ahmed M; Vaughan, Lisa E et al. (2017) Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis. Am J Obstet Gynecol 216:500.e1-500.e11
Yao, X; Stewart, E A; Laughlin-Tommaso, S K et al. (2017) Medical therapies for heavy menstrual bleeding in women with uterine fibroids: a retrospective analysis of a large commercially insured population in the USA. BJOG 124:322-330
Borah, Bijan J; Laughlin-Tommaso, Shannon K; Myers, Evan R et al. (2016) Association Between Patient Characteristics and Treatment Procedure Among Patients With Uterine Leiomyomas. Obstet Gynecol 127:67-77
Laughlin-Tommaso, Shannon K; Khan, Zaraq; Weaver, Amy L et al. (2016) Cardiovascular risk factors and diseases in women undergoing hysterectomy with ovarian conservation. Menopause 23:121-8
AbdElmagied, Ahmed M; Vaughan, Lisa E; Weaver, Amy L et al. (2016) Fibroid interventions: reducing symptoms today and tomorrow: extending generalizability by using a comprehensive cohort design with a randomized controlled trial. Am J Obstet Gynecol 215:338.e1-338.e18
Laughlin-Tommaso, Shannon K; Borah, Bijan J; Stewart, Elizabeth A (2015) Effect of menses on standardized assessment of sexual dysfunction among women with uterine fibroids: a cohort study. Fertil Steril 104:435-9
Hodge, Jennelle C; Pearce, Kathryn E; Clayton, Amy C et al. (2014) Uterine cellular leiomyomata with chromosome 1p deletions represent a distinct entity. Am J Obstet Gynecol 210:572.e1-7

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