The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant.
A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs.
Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive.
A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.
|Symptomatic Uterine Leiomyomas Fibroids Uterine Fibroids Myomas||Procedure: Focused ultrasound (MRgFUS) Procedure: Uterine artery embolization (UAE)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids|
- Symptomatic outcomes measured by validated instruments [ Time Frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment. ]
- Adverse events following treatment [ Time Frame: At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment. ]
- Biologic predictors of outcome [ Time Frame: Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|Active Comparator: Focused Ultrasound (MRgFUS)||
Procedure: Focused ultrasound (MRgFUS)
MRgFUS treatment will take place in a MRI machine and powerful ultrasound waves go through the abdominal wall to destroy the fibroid or fibroids. No incision is made during this treatment and light sedation is required. There are certain fibroids that may not be treated with this technique and there is no treatment of normal uterine tissue.ough the abdominal wall to destroy the fibroid.
Other Name: ExAblate 2000
|Active Comparator: Uterine Artery Embolization (UAE)||
Procedure: Uterine artery embolization (UAE)
UAE treatment takes place on a regular x-ray machine. A small incision is made where the leg meets the trunk and a small tube is used to use very small pellets to block off the blood supply to the entire uterus. Sedation is used. Most fibroids are treated with this technique and normal uterine tissue is also affected.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995878
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94116|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Elizabeth A. Stewart, M.D.||Mayo Clinic|