Comparing focused ultrasound and uterine artery embolization for uterine fibroids-rationale and design of the Fibroid Interventions: reducing symptoms today and tomorrow (FIRSTT) trial.

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.