The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (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.

Inclusion Criteria:

1. Women able to give informed consent and willing and able to attend all study visits

2. Premenopausal women at least 25 years of age

3. No evidence of High Grade SIL by pap smears or HPV testing within institutional
guidelines.

Exclusion Criteria:

1. Women actively trying for pregnancy or currently pregnant

2. Uterine size > 20 weeks

3. Prior myomectomy, UAE, or MRgFUS. Previous hysteroscopic or laparoscopic myomectomy
for the removal of only pedunculated leiomyomas (as described in #17, below) will be
allowed and evaluated on an individual basis to determine eligibility for treatment.

4. More than 6 fibroids > than 3 centimeters in maximal diameter

5. Allergy to either gadolinium or iodinated contrast

6. Implanted metallic device prohibiting MRI

7. Severe claustrophobia

8. BMI which prohibits subject from fitting in MRI device

9. Severe abdominal scarring precluding safe MRgFUS treatment

10. Active pelvic infection

11. Intrauterine contraceptive device in place at the time of treatment

12. Current use of GnRH agonists or antagonists

13. Unstable medical conditions requiring additional monitoring during the procedure

14. Bleeding diathesis requiring medical treatment

15. Imaging suggestive of malignant disease of uterus, ovary, or cervix

16. Imaging suggestive of only adenomyosis

17. Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal
fibroid diameter