Uterine Leiomyoma Clinical Trial
Official title:
Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound
The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment of uterine fibroids in Northwestern Ontario, which is a rural and remote setting.
Uterine fibroids are benign smooth muscle tumours of the muscular wall of the uterus that
affect 40 per cent of women. While the majority of fibroids are asymptomatic, fibroids may
cause menorrhagia, bulk symptoms (i.e. ureteric obstruction, urinary frequency and urgency,
bowel dysfunction), pain and in certain instances infertility.
Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) treatment of
fibroids is an established method for symptom alleviation with over 3000 women receiving
treatment worldwide. MR-HIFU is a non-invasive, non-surgical procedure that uses ultrasound
energy to thermally ablate the fibroid leading to a reduction in bleeding and in the size of
uterine fibroids over time. MR-HIFU it is not currently being used for the treatment of
symptomatic fibroids in Canada.
The Thunder Bay Regional Research Institute has one of the first clinically available MR-HIFU
equipment in Canada. In order to bring this technology into clinical practice, a knowledge
translation study is needed to demonstrate that MR-HIFU can treat symptomatic uterine
fibroids as successfully in Northwestern Ontario compared to urban centres where all of the
clinical trials have been conducted. The ability to screen and follow up women treated with
MR-HIFU with ultrasound rather than MRI would allow participants to receive follow up in
regional centres in Northwestern Ontario and it would be more cost effective from a health
system perspective. In addition, more research is needed to broaden the scope of treatment to
include fibroids greater than 8 cm such that more women could benefit from this non-surgical
fibroid management option.
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