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.