Safety and Efficacy of Ultrasound-Guided High-Intensity Focused Ultrasound Treatment for Uterine Fibroids and Adenomyosis.

The objective of this study was to assess the tolerability and efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) ablation using a Haifu JC Focused Ultrasound Tumor Therapeutic System (operating transducer frequency: 0.8 MHz, 300-400 W/cm2) under real-time ultrasound guidance (2.5- to 5.0-MHz imaging probe) for uterine fibroids and adenomyosis in 1807 patients (928 with fibroids and 889 with adenomyosis). Volume change and clinical symptom improvement after treatment were evaluated based on symptom severity scores and health-related quality of life scores using the Uterine Fibroid Symptom and Quality of Life questionnaires. At 3, 6 and 12 mo after treatment, symptom severity scores and health-related quality of life scores and reductions in volumes of uterine adenomyosis and fibroids all revealed good effects. The complication rate was 4.6% (84/1807). With supportive care, all complications resolved without any permanent adverse effects. Thus, USgHIFU is an effective, non-invasive modality for treating uterine fibroids and adenomyosis with manageable complications.