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.