British Congress of Obstetrics and Gynaecology, Glasgow, 8th July 2004
PURPOSE: We present the findings of a multi-centre prospective study of the use of MR guided Focused Ultrasound Surgery in the treatment of symptomatic fibroids.
MATERIALS AND METHODS: Patients who presented to the gynaecology clinics in the participating hospitals with symptomatic fibroids and who would have otherwise been offered surgery were considered for MRgFUS. Seven sites participated in the study. 108 women met the inclusion criteria and were recruited. Focused Ultrasound Surgery is a non-invasive technique that uses consecutive sonications of high intensity ultrasound within a defined target area to produce a volume of ablated tissue. In this series up to four fibroids were treated in any one patient. The maximum planned treatment volume was stipulated as 100 cm3 per fibroid or 150 cm3 per patient where multiple fibroids were treated.
MRI scan performed with Gadolinium based contrast enables the measurement of total fibroid volume and non-perfused volume post-treatment.
Symptom and quality of life scores were measured prior to treatment and at three and six months after treatment using the Uterine Fibroid Symptoms and Quality of Life questionnaire (UFS-QOL). Adverse events were monitored at follow up, using a structured interview.
RESULTS: Results at six months show a mean fibroid volume reduction of 13.5%. In comparison, clinical follow up demonstrates that 79.3% of patients have a greater than 10 point reduction in the UFS-QOL score (n=82, p<0.00001). Mean reduction in symptom severity score was 27.3, the majority occurring in the first 3 months. This improvement was seen in both menstrual bleeding and pressure symptoms.
MR guided FUS is extremely well tolerated as an outpatient procedure. Pain reported during treatment was graded as none, mild, moderate or severe. Whilst 16% described severe pain during treatment only 1% and 7% stated that they were in severe or moderate pain, respectively, when questioned immediately after the treatment. Of the 9 reported serious adverse events only one was felt to be definitely device related. This patient suffered leg and buttock pain following treatment, which resolved by the final visit. Only one patient required admission to hospital following treatment due to nausea following opiate administration. Other reported adverse events were minor and transitory.
CONCLUSION: We believe that MRgFUS is an effective, low risk, non-invasive treatment for a wide range of patients with symptomatic fibroids.
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