Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids (PROMISe)

• Fibroid volume measured on MRI [ Time Frame: Change from baseline prior to treatment until 3 months after treatment ] [ Designated as safety issue: No ]
• Fibroid symptoms reported by participant [ Time Frame: Change from baseline prior to treatment to 1 and 3 months after treatment ] [ Designated as safety issue: No ]
• Red blood cell count (hematocrit) [ Time Frame: Change from baseline prior to treatment and 3 months after treatment ] [ Designated as safety issue: No ]

This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.

• Procedure: MR Guided Focused Ultrasound
  This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.
• Procedure: Placebo MR Guided Focused Ultrasound
  This is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid.

• Active Comparator: MR Guided Focused Ultrasound
  Intervention: Procedure: MR Guided Focused Ultrasound
• Placebo Comparator: Placebo MR Guided Focused Ultrasound
  Intervention: Procedure: Placebo MR Guided Focused Ultrasound

Inclusion Criteria:

• Age>18 years
• Premenopausal
• Symptomatic fibroids
• Fibroids accessible for focused ultrasound treatment

Exclusion criteria:

• Desires future fertility
• Current pregnancy
• Hematocrit <30%
• Emergency room visit in last 3 months for fibroid symptoms
• History of venous thromboembolism
• Fibroids that are: >10cm, non-enhancing with contrast
• Adenomyosis
• Contraindications to undergoing MRI
• Unexplained menstrual irregularity