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.

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.