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

31 Citations (Scopus)

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

Fingerprint

Uterine Artery Embolization
Leiomyoma
Randomized Controlled Trials
United States Food and Drug Administration
Therapeutics
Health Personnel
Patient Care
Magnetic Resonance Spectroscopy
Economics
Quality of Life
Outcome Assessment (Health Care)
Clinical Trials

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Reproductive Medicine

Cite this

Comparing focused ultrasound and uterine artery embolization for uterine fibroids - Rationale and design of the Fibroid Interventions : Reducing Symptoms Today and Tomorrow (FIRSTT) trial. / Bouwsma, Esther V A; Hesley, Gina K.; Woodrum, David A; Weaver, Amy L.; Leppert, Phyllis C.; Peterson, Lisa G.; Stewart, Elizabeth A.

In: Fertility and Sterility, Vol. 96, No. 3, 09.2011, p. 704-710.

Research output: Contribution to journalArticle

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