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, six weeks post-treatment, and at six, 12, 24, and 36 months following treatment with UAE and MRgFUS.
Subjects will be reimbursed up to $350 for expenses related to study participation. If a subject chooses to withdraw from the study early, or is withdrawn by her doctor, she will be compensated for her participation up to the time of withdrawal.
For more information, contact Patrick Barrera at 919-668-2349.