Evidence Table. Clinical Area: MR-guided focused ultrasound surgery with
ExAblate system for treatment of uterine fibroids. Reference: Funaki K et al.
Evidence Table Clinical Area: Reference:
MR-guided focused ultrasound surgery with ExAblate system for treatment of uterine fibroids Funaki K et al. Subjective effect of magnetic resonance-guided focused ultrasound surgery for uterine fibroids. J Obstet Gynecol 2007; 33: 834-839.
Study Type: Case Series Study Aim: To report on outcomes after MR-guided focused ultrasound surgery (MRgFUS) with ExAblate system for treatment of uterine fibroids Outcomes • Primary: Did not specify primary outcome. Outcomes included: symptom severity (tool developed by researchers; 14 items, each rated 1-5), patient satisfaction, self-assessment of overall improvement. Design • Number of subjects: N=69 • Description of study population: Study conducted in Japan. Mean patient age=40 years (range 26-48). Fibroid diameter ranged from 3 to 14 cm. • Inclusion criteria: Symptomatic uterine fibroids. • Exclusion criteria: Pregnancy, postmenopausal status, major medical disease, contraindication to MRI or gadolinium-injection solution. • Consecutive patients? Not reported. • Intervention: Patients received MRgFUS using the ExAblate 2000 system (InSightec). Patients were given oral diazepam for anxiety before moving to the MRI room, and IV pentazocine for pain relief just before the first sonication. The minimum margin size from the edge of the ablated area to the edge of the uterus was 0.5 cm. A maximum of 4 fibroids were treated in one session. Mean sonication time was 2 hours 30 minutes (± 39 minutes). 18 patients had a second MRgFUS procedure because of large or multiple fibroids. • Source of outcome data: Self-report measures. • Length of follow-up: Mean follow-up=15 months; minimum follow-up=7 months. Validity • Was population homogenous? Appeared to be. • Potential selection biases: No specific biases identified. • Were intervention/ care/follow-up similar in each group? 22 of the patients received gonadotrophin-releasing hormone analog (GnRHa) before MRgFUS treatment; 18 patients had a second MRgFUS procedure and 7 patients received alternative treatment within 12 months. • Did an objective observer assess outcomes? No. • Completeness of follow-up: Some follow-up on all patients. • Industry funding? Did not report funding source.
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Conclusions regarding validity of methods: Subject to bias due to lack of comparison and control group in conjunction with subjective self-report measures. Moreover, the researchers did not use a validated symptom assessment tool.
Results Symptom severity score results were reported in a figure; exact scores were not reported Time to improvement of selected symptoms, No. patients U
Frequent urination Enlarged abdomen sensation Dysmenorrhea Heavy bleeding
