Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial

Esther V A Bouwsma, Gina K. Hesley, David A Woodrum, Amy L. Weaver, Phyllis C. Leppert, Lisa G. Peterson, Elizabeth A Stewart

Research output: Contribution to journalArticle

32 Scopus citations

Abstract

Objective: To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study. Design: Randomized clinical trial. Setting: Two academic medical centers. Patient(s): Premenopausal women with symptomatic uterine fibroids. Intervention(s): 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. Main Outcome Measure(s): 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. Result(s): The trial is currently in the phase of active recruitment. Conclusion(s): 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. Clinical Trial Registration: NCT00995878.

Original languageEnglish (US)
Pages (from-to)704-710
Number of pages7
JournalFertility and Sterility
Volume96
Issue number3
DOIs
StatePublished - Sep 2011

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Keywords

  • economic analysis
  • focused ultrasound
  • Leiomyomas
  • MRgFUS
  • randomized clinical trial
  • uterine artery embolization

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Reproductive Medicine

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