title: Comparing focused ultrasound and uterine artery embolization for uterine fibroids-rationale and design of the Fibroid Interventions: reducing symptoms today and tomorrow (FIRSTT) trial.
abstract: OBJECTIVE
  To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study.
  
  
  METHODS
  Randomized clinical trial.
  
  
  METHODS
  Two academic medical centers.
  
  
  METHODS
  Premenopausal women with symptomatic uterine fibroids.
  
  
  METHODS
  Participants are randomized to two U.S. Food and Drug Administration-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization and magnetic resonance-guided focused ultrasound.
  
  
  METHODS
  The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health-related quality of life, impairment of ovarian reserve, treatment complications, and the economic impact of these issues.
  
  
  RESULTS
  The trial is currently in the phase of active recruitment.
  
  
  CONCLUSIONS
  This randomized clinical trial will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas.
  
  
  BACKGROUND
  NCT00995878.
authors.affiliation: Center for Uterine Fibroids, Mayo Clinic, Rochester, Minnesota; Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota 55901, USA.
authors.forename: Esther V A
authors.initials: EV
authors.lastname: Bouwsma
authors.forename: Gina K
authors.initials: GK
authors.lastname: Hesley
authors.forename: David A
authors.initials: DA
authors.lastname: Woodrum
authors.forename: Amy L
authors.initials: AL
authors.lastname: Weaver
authors.forename: Phyllis C
authors.initials: PC
authors.lastname: Leppert
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Peterson
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Stewart
mesh_terms: D004621:Embolization, Therapeutic / Q000379:methods*; D019317:Evidence-Based Medicine / Q000379:methods; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D011788:Quality of Life; D012107:Research Design; D014463:Ultrasonography; D055988:Uterine Artery / Q000000981:diagnostic imaging*; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*