Ultrasound-guided high-intensity focused ultrasound for symptomatic uterine fibroids: clinical outcome of two European centers.

Abstract

Objectives: The aim of this study is to assess the clinical outcome and mid-term efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) as a treatment for symptomatic uterine fibroids at two major European HIFU centers.

Materials and methods: This bi-center longitudinal clinical study involved the treatment of 100 patients with symptomatic uterine fibroids using USgHIFU (n = 59 in Germany, n = 41 in Bulgaria). Clinical outcomes were evaluated at 6 weeks, 6 months, and 1 year follow-up utilizing the uterine fibroid symptoms-quality of life questionnaire for fibroid-related symptoms and health-related quality of life as well as MRI imaging for determining the fibroid volume.

Results: The mean fibroid volume reduction rate was 33.2 ± 22.9%, 51.3 ± 24.2%, and 59.1 ± 28.0% at 6 weeks, 6 months, and 1 year, respectively (each p < 0.001). The mean symptom severity score decreased from 43.9 ± 18.8 at baseline to 35.4 ± 18.2 at 6 weeks, 31.1 ± 20.0 at 6 months, and 23.1 ± 14.0 at 1 year (each p < 0.001). The mean QOL score improved from 56.5 ± 23.4 at baseline to 65.4 ± 22.2 at 6 weeks, 72.5 ± 19.5 at 6 months, and 79.4 ± 15.3 at 1 year (each p < 0.001). No major complications were observed, though two patients experienced temporary sciatic nerve irritation following the procedure. Four patients had pregnancies and deliveries without any complications after USgHIFU therapy.

Conclusion: To our knowledge, this is the first longitudinal study conducted in two major European HIFU centers that reveals the clinical efficacy of USgHIFU ablation on symptomatic uterine fibroids. Our results confirm that USgHIFU is a non-invasive approach with a low risk of complications, offering an innovative treatment option for affected women.

Key points: Question To evaluate mid-term clinical efficacy and safety of US-guided high-intensity focused ultrasound (HIFU) for treating symptomatic uterine fibroids and patient outcomes across two European centers. Findings US-guided HIFU treatment resulted in significant fibroid volume reduction (up to 59.1% after 1 year) improving symptoms and quality of life with no major complications. Clinical relevance This prospective longitudinal study provides preliminary data assessing mid-term efficacy and clinical outcomes of ultrasound-guided HIFU. It is shown to be a low-risk, non-invasive treatment option for symptomatic uterine fibroids that reduces fibroid size and improves patients' quality of life.