The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids
Uterine fibroids affect up to 70 to 80% of women and about 30% of women are symptomatic.
Over 200,000 hysterectomies are performed each year for uterine fibroids in the USA. The
direct health care costs attributable to uterine fibroids exceed $2.1 billion annually.
Fibroids are reported to cause a number of symptoms including heavy or prolonged menstrual
bleeding, pelvic pressure, pain with menses and bowel and bladder dysfunction. However,
fibroid symptomatology is incompletely understood. Understanding and addressing the myomas
pain are important in optimizing treatment outcomes and controlling health care costs from a
societal perspective. This study proposes to optimally characterize symptoms and symptom
relief in women with leiomyomas severe enough to seek interventional therapy. Secondly we
will characterize a variety of symptoms utilizing standardized instruments for other pelvic
diseases and symptoms to optimize comparisons with other disease processes.
Clinical and scientific significance of the studies is high. We look to generate resources
which can be used at a later time to assess the biologic and genetic variables affecting
treatment outcome and to comprehensively assess the societal economic impact of uterine
fibroids and their treatment with UAE and MRgFUS.
Participants will be in the study for up to 36 months following fibroid treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Symptomatic outcomes measured by validated instruments
At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.
Elizabeth A. Stewart, M.D.
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Duke University Health System||Durham, North Carolina 27705|