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.

Keywords: Fibroid-related symptoms; Health-related quality of life; High-intensity focused ultrasound (HIFU); Non-invasive treatment option; Symptomatic uterine fibroids.

Fig. 1

Study consort diagram: assessment of eligibility

Fig. 2

Initial pre-interventional fibroid volume (mL) in group 1 (G1) and group 2 (G2). Measurements were made on T2-weighted MRI

Fig. 3

Uterine fibroid volume (mL) (a) and fibroid volume reduction rate (%) (b) after USgHIFU intervention compared to baseline in G1 and G2 are shown; p-values refer to comparison with baseline (*p ≤ 0.05; **p < 0.01; ***p < 0.001)

Fig. 4

MRI images (transverse T2-weighted sequences) of the pelvis of a 41-year-old premenopausal patient are shown. The patient presented with severe fibroid-associated symptoms (hypermenorrhea, dysmenorrhea, anemia, pelvic pain and feeling of pressure). The predominant target fibroid was located in the fundus of the uterus. In the 1-month follow-up, a significant reduction in symptoms and fibroid volume was observed. a Large predominant target fibroid in the fundus of the uterus (white arrows) prior to HIFU treatment. b Significant fibroid shrinkage was observed at 3 months with a 54% reduction in lesion volume. c, d Fibroid volume reduction of approximately 85% at 6 months (c) and 94% at 1 year (d) post-HIFU

Fig. 5

Contrast-enhanced ultrasound images of the uterus of a 41-year-old premenopausal woman with symptomatic uterine fibroids are shown. The predominant target fibroid in the fundus of the uterus was treated with USgHIFU. a Predominant target fibroid in the fundus of the uterus (white arrows) with contrast enhancement prior to HIFU treatment. b Immediately after HIFU ablation (2 h post-HIFU), a large area without contrast enhancement is shown (white arrows). c, d A significant reduction in fibroid volume of approximately 54% after 3 months (c) and 85% after 6 months (d) compared to the initial lesion volume was observed

Fig. 6

Health-related quality of life (HRQoL) (a) and symptom severity score (SSS) (b) after USgHIFU compared with baseline values in G1 and G2; p-values refer to comparison with baseline values (*p ≤ 0.05; **p < 0.01; ***p < 0.001)