Elizabeth A. Stewart, M.D. of the Department of Obstetrics and Gynecology at Mayo Clinic discusses a study comparing focused ultrasound and uterine artery embolization in premenopausal women with symptomatic uterine fibroids: Comparing focused ultrasound and uterine artery embolization for uterine fibroids — Rationale and design of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial.
A description of the study, which is currently in the phase of active recruitment, is published in the September 2011 issue of Fertility and Sterility.
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
Patients
Premenopausal women with symptomatic uterine fibroids
Interventions
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 Measures
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
- Economic impact of these issues
Results
The trial is currently in the phase of active recruitment.
Conclusions
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.
Authors
Esther V.A. Bouwsma, M.D., Gina K. Hesley, M.D., David A. Woodrum, M.D., Ph.D., Amy L. Weaver, M.S., Phyllis C. Leppert, M.D., Ph.D., Lisa G. Peterson, R.N., M.A.N., Elizabeth A. Stewart, M.D.
Clinical Trial registration
NCT00995878
