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.

Eligibility Requirements

Inclusion Criteria

• Women able to give informed consent and willing and able to attend all study visits
• Premenopausal women at least 25  years of age
• No evidence of high-grade SIL by pap smears or HPV testing within institutional guidelines
• Women must be African American

Exclusion Criteria

• Women actively trying for pregnancy or currently pregnant
• Uterine size greater than 20 weeks
• Prior UAE, or MRgFUS
• More than six fibroids that are greater than three centimeters in maximal diameter
• Allergy to either gadolinium or iodinated contrast
• Implanted metallic device prohibiting MRI
• Severe claustrophobia
• BMI which prohibits subject from fitting in MRI device
• Severe abdominal scarring precluding safe MRgFUS treatment
• Active pelvic infection
• Intrauterine contraceptive device in place at the time of treatment
• Current use of GnRH agonists or antagonists
• Unstable medical conditions requiring additional monitoring during the procedure
• Bleeding diathesis requiring medical treatment
• Imaging suggestive of malignant disease of uterus, ovary, or cervix
• Imaging suggestive of only adenomyosis
• Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal fibroid diameter

Compensation

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 If a subject chooses to withdraw from the study early, or is withdrawn by her doctor, she will be compensated for her participation up to the time of withdrawal.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.