Objectives <p>Uterine fibroids often lead to symptoms that negatively impact health-related quality of life (HRQOL). High-intensity focused ultrasound (HIFU) has emerged as a promising noninvasive treatment for reducing fibroid size and symptoms. The Mirabilis system for ultrasound (US)-guided HIFU introduces a novel technique known as ‘shell ablation’. This study evaluates the feasibility and efficacy of Mirabilis in a clinical setting, focusing on clinical outcomes.</p> Materials and methods <p>Sixteen patients with 23 uterine fibroids were treated with the Mirabilis system. Follow-up assessments included US and MRI at baseline, 6&#xa0;weeks, 3, 6 and 9&#xa0;months, and 1&#xa0;year after HIFU. Changes in symptoms and QOL were evaluated using the Uterine Fibroid Symptom and HRQOL Questionnaire.</p> Results <p>A significant reduction in fibroid volume was observed after HIFU (baseline 182.1 ± 49.3&#xa0;ml; 1&#xa0;year: 76.0 ± 37.9&#xa0;ml, p &lt; 0.001). The symptom severity score significantly declined (baseline 57.2 ± 3.8; 1&#xa0;year: 30.2 ± 4.9, p &lt; 0.001), correlating with a significant improvement in HRQOL (baseline 47.0 ± 3.9, 1&#xa0;year: 71.8 ± 5.3, p &lt; 0.001).</p> Conclusion <p>HIFU with the portable Mirabilis system is a feasible and safe noninvasive treatment for symptomatic uterine fibroids in an outpatient setting. This approach allows efficient and rapid ablation even for large fibroids, significantly reducing fibroid volume and symptoms.</p>

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Ablation of symptomatic uterine fibroids with the Mirabilis system for rapid noninvasive ultrasound-guided high-intensity focused ultrasound (HIFU): a prospective observational clinical study

  • Tolga Tonguc,
  • Oleksandr Savchenko,
  • Olga Ramig,
  • Judith M. Stader,
  • Franziska Kießling,
  • Jim Küppers,
  • Eva K. Egger,
  • Marcus Thudium,
  • Patrick Martin,
  • Wayne Poll,
  • Hans H. Schild,
  • Rupert Conrad,
  • Markus Essler,
  • Alexander Mustea,
  • Holger M. Strunk,
  • Milka Marinova

摘要

Objectives

Uterine fibroids often lead to symptoms that negatively impact health-related quality of life (HRQOL). High-intensity focused ultrasound (HIFU) has emerged as a promising noninvasive treatment for reducing fibroid size and symptoms. The Mirabilis system for ultrasound (US)-guided HIFU introduces a novel technique known as ‘shell ablation’. This study evaluates the feasibility and efficacy of Mirabilis in a clinical setting, focusing on clinical outcomes.

Materials and methods

Sixteen patients with 23 uterine fibroids were treated with the Mirabilis system. Follow-up assessments included US and MRI at baseline, 6 weeks, 3, 6 and 9 months, and 1 year after HIFU. Changes in symptoms and QOL were evaluated using the Uterine Fibroid Symptom and HRQOL Questionnaire.

Results

A significant reduction in fibroid volume was observed after HIFU (baseline 182.1 ± 49.3 ml; 1 year: 76.0 ± 37.9 ml, p < 0.001). The symptom severity score significantly declined (baseline 57.2 ± 3.8; 1 year: 30.2 ± 4.9, p < 0.001), correlating with a significant improvement in HRQOL (baseline 47.0 ± 3.9, 1 year: 71.8 ± 5.3, p < 0.001).

Conclusion

HIFU with the portable Mirabilis system is a feasible and safe noninvasive treatment for symptomatic uterine fibroids in an outpatient setting. This approach allows efficient and rapid ablation even for large fibroids, significantly reducing fibroid volume and symptoms.