What question did this study set out to answer?

To evaluate the effectiveness of MR-HIFU in reducing symptoms related to uterine fibroids after 12 months.

June 17, 2026Open Access

Magnetic resonance‐guided high‐intensity focused ultrasound ( MR ‐ HIFU ) therapy of uterine fibroids effectively reduces both bleeding and bulk symptoms—A prospective single‐center 12‐month follow‐up study

Key Points

To evaluate the effectiveness of MR-HIFU in reducing symptoms related to uterine fibroids after 12 months.
Prospective study including 163 women with uterine fibroids.
Assessments of symptom severity and quality of life conducted at baseline, 3 months, and 12 months.
Non-perfused volume ratio (NPV%) measured post-treatment.
Mean NPV% after MR-HIFU was 62%.
Symptom severity score significantly reduced from baseline by 12 months (p < 0.001).
Quality of life increased significantly across all follow-up points in bleeding patients (p < 0.05) and in bulk patients from baseline to 3 months (p < 0.001).

Abstract

INTRODUCTION: Uterine fibroids are common benign neoplasms in women. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) is a noninvasive treatment that has been shown to reduce fibroid-related symptoms and improve quality of life (QoL). In this study, we aimed to clarify symptom reduction in patients with isolated bleeding or bulk symptoms. MATERIAL AND METHODS: This prospective study with a 12-month follow-up included 163 women with uterine fibroids causing either bleeding or bulk symptoms and deemed suitable for MR-HIFU treatment. Treatments were carried out using an extracorporeal tabletop MR-HIFU system (Sonalleve V2, Profound Medical Inc., Mississauga, Canada). The non-perfused volume ratio (NPV%) was determined after treatment. Symptom severity and QoL were assessed using the Uterine Fibroid Symptom and Quality of Life questionnaire at baseline, 3 months, and 12 months after treatment. The study was registered at ClinicalTrials.gov (NCT02914704). RESULTS: A total of 122 women with bleeding and 41 women with bulk symptoms were included. The overall mean NPV% for all patients was 62%. The median symptom severity score (SSS) at baseline was 56 (IQR 47-69) and 46 (34-63), at 3 months 28 (16-44) and 19 (6-30), and at 12 months 25 (13-31) and 19 (6-41) for the bleeding and bulk groups, respectively. The reduction of SSS was statistically significant between baseline and 3 months (p < 0.001) and between baseline and 12 months (p < 0.001) in both groups. The median of QoL at baseline was 43 (IQR 31-58) and 74 (45-83), at 3 months 70 (53-82) and 89 (74-97), and at 12 months 82 (69-91) and 82 (67-100) for the bleeding and bulk groups, respectively. In the bleeding patients, the increase in QoL was statistically significant between all the time points compared (p < 0.05). In the bulk group, the increase in QoL was statistically significant from baseline to 3 months (p < 0.001) and from baseline to 12 months (p < 0.01). CONCLUSIONS: MR-HIFU resulted in significant symptom reduction and improved QoL in patients with both bleeding and bulk-related fibroid symptoms. When successful, MR-HIFU provides effective and rapid symptom relief for both symptom types.

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