The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

What is involved?

If you are eligible for this study, you will be put into one of two groups by chance (as in the flip of a coin). This is called randomization. Since your treatment (FUS or UAE) will be assigned by chance, you will not be able to choose which treatment you receive. You will have an equal chance (50/50) of being in either the FUS treatment group or receiving the UAE. You will be eligible for this study if both treatment techniques are options for you.

FUS treatment takes place in a MRI machine and powerful ultrasound waves go through the abdominal wall to destroy the fibroid. No incisions are made and each fibroid is targeted separately.  Sometimes, there are fibroids that can?t be treated using this technique.
UAE treatment takes place on a regular x-ray machine. A small incision is made where the leg meets the trunk and a small tube is used to insert very small pellets in place to block off the blood supply to the uterus.  Only rarely are there certain fibroids can not be treated using this technique.  

You will be asked to complete eight questionnaires about your general health, fibroid symptoms, depression, and health care costs. You will be asked to complete these questionnaires before you receive treatment and periodically during the 36 months following treatment.

You will receive compensation for your time.

How long is the study?

You will be in this study up to 36 months following fibroid treatment.

Last updated:

4/22/2014

NCT ID:

NCT00995878

IRB Number:

09-005095