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.
MR-HIFU therapy significantly reduces symptoms and improves quality of life in women with uterine fibroids over a 12-month period.
Where it sits
this study against the rest of the carbetocin corpusSummary and findings
This study measured symptom reduction and quality of life (QoL) improvements in 163 women with uterine fibroids treated with magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU). The overall mean non-perfused volume ratio (NPV%) was 62%. Significant reductions in symptom severity scores were observed at 3 and 12 months post-treatment.
Abstract
<h4>Introduction</h4>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.<h4>Material and methods</h4>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).<h4>Results</h4>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).<h4>Conclusions</h4>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.
Background
This paper addresses the effectiveness of MR-HIFU therapy in reducing symptoms associated with uterine fibroids, which are prevalent benign tumors in women. Prior research has indicated that MR-HIFU can alleviate fibroid-related symptoms and enhance quality of life, but specific outcomes for isolated bleeding or bulk symptoms were not well-defined. This study aims to provide clarity on symptom reduction and quality of life improvements over a 12-month period following treatment.
Methods
This prospective study included 163 women with uterine fibroids causing either bleeding or bulk symptoms, who were suitable for MR-HIFU treatment. The treatments were administered using an extracorporeal tabletop MR-HIFU system (Sonalleve V2). The primary outcomes were symptom severity and quality of life, assessed at baseline, 3 months, and 12 months post-treatment.
Results
The overall mean non-perfused volume ratio (NPV%) was 62%. The median symptom severity score (SSS) at baseline was 56 (IQR 47-69) for bleeding and 46 (34-63) for bulk symptoms. At 3 months, the SSS was significantly reduced to 28 (16-44) for bleeding and 19 (6-30) for bulk symptoms (p<0.001). At 12 months, the SSS was 25 (13-31) for bleeding and 19 (6-41) for bulk symptoms (p<0.001). The median quality of life (QoL) scores improved significantly from baseline to 3 months and 12 months.
Interpretation
The findings suggest that MR-HIFU is effective in reducing symptom severity and improving quality of life for women with uterine fibroids, aligning with previous literature on the subject. However, while the statistical significance of the results is clear, the clinical significance of the effect sizes remains to be fully established, particularly given the potential for confounding factors such as the study's single-center design and the lack of a control group.
Key findings
- Overall mean NPV% for all patients was 62%.
- Median symptom severity score (SSS) at baseline was 56 (IQR 47-69) for bleeding and 46 (34-63) for bulk symptoms.
- At 3 months, SSS was 28 (16-44) for bleeding and 19 (6-30) for bulk symptoms.
- At 12 months, SSS was 25 (13-31) for bleeding and 19 (6-41) for bulk symptoms.
- Median QoL at baseline was 43 (IQR 31-58) for bleeding and 74 (45-83) for bulk symptoms.
- At 3 months, QoL was 70 (53-82) for bleeding and 89 (74-97) for bulk symptoms.
Limitations
- Single-center study may limit generalizability.
- No control group for comparison.
- Potential selection bias in patient population.
- Follow-up duration may not capture long-term outcomes.