Comparing focused ultrasound and uterine artery embolization for uterine fibroids-rationale and design of the Fibroid Interventions: reducing symptoms today and tomorrow (FIRSTT) trial.
Journal Article (Journal Article)
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.
Full Text
Duke Authors
Cited Authors
- Bouwsma, EVA; Hesley, GK; Woodrum, DA; Weaver, AL; Leppert, PC; Peterson, LG; Stewart, EA
Published Date
- September 2011
Published In
Volume / Issue
- 96 / 3
Start / End Page
- 704 - 710
PubMed ID
- 21794858
Pubmed Central ID
- PMC3165063
Electronic International Standard Serial Number (EISSN)
- 1556-5653
Digital Object Identifier (DOI)
- 10.1016/j.fertnstert.2011.06.062
Language
- eng
Conference Location
- United States