Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids (PROMISe)

Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial

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.

Fibroids, Uterine, Focused Ultrasound, Magnetic Resonance focused ultrasound, HIFU, NOninvasive, Treatment

This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.

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.

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

Jacoby VL, Kohi MP, Poder L, Jacoby A, Lager J, Schembri M, Rieke V, Grady D, Vittinghoff E, Coakley FV. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. 2016 Mar;105(3):773-780. doi: 10.1016/j.fertnstert.2015.11.014. Epub 2015 Dec 1.