Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids (PROMISe)
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Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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