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). 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 #
5R01HD060503-05
Application #
8712522
Study Section
Special Emphasis Panel (ZRG1-EMNR-A (50))
Program Officer
Parrott, Estella C
Project Start
2010-08-01
Project End
2015-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
5
Fiscal Year
2014
Total Cost
$593,545
Indirect Cost
$184,408
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
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; Khan, Zaraq; Weaver, Amy L et al. (2016) Cardiovascular risk factors and diseases in women undergoing hysterectomy with ovarian conservation. Menopause 23:121-8
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; 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
Eltoukhi, Heba M; Modi, Monica N; Weston, Meredith et al. (2014) The health disparities of uterine fibroid tumors for African American women: a public health issue. Am J Obstet Gynecol 210:194-9
Cain-Nielsen, Anne H; Moriarty, James P; Stewart, Elizabeth A et al. (2014) Cost-effectiveness of uterine-preserving procedures for the treatment of uterine fibroid symptoms in the USA. J Comp Eff Res 3:503-14
Puri, Kanchan; Famuyide, Abimbola O; Erwin, Patricia J et al. (2014) Submucosal fibroids and the relation to heavy menstrual bleeding and anemia. Am J Obstet Gynecol 210:38.e1-7
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
Laughlin-Tommaso, Shannon K; Stewart, Elizabeth A; Grossardt, Brandon R et al. (2014) Incidence, time trends, laterality, indications, and pathological findings of unilateral oophorectomy before menopause. Menopause 21:442-9
Stewart, Elizabeth A; Nicholson, Wanda K; Bradley, Linda et al. (2013) The burden of uterine fibroids for African-American women: results of a national survey. J Womens Health (Larchmt) 22:807-16

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