Efficacy and Safety of Transvaginal High-Intensity Focused Ultrasound Therapy in Women with Symptomatic Uterine Leiomyomas: A Clinical Trial

Dr. Jae Young Lee and colleagues at Seoul National University recently published the results from a clinical trial using a novel approach and device to treat patients with uterine fibroids: transvaginal high-intensity focused ultrasound (vHIFU).

UF illustrationThirteen premenopausal women with 33 contrast-enhanced, less than 5-cm uterine leiomyomas participated in the study, which took place at two centers over a period of 14 months. The researchers used Alpinion Medical Systems’ RODIN HIFU system with sedation or monitored anesthesia. The RODIN system has a positioning module, two imaging probes (one transabdominal and one transvaginal), and one vHIFU treatment probe. The primary endpoint was the non-perfused volume (NPV) ratio measured immediately after therapy, and it surpassed the non-inferiority cutoff of 0.5 by reaching 0.76 ± 0.27 (mean ± SD). Secondary endpoints of quality-of-life scores, dysmenorrhea, and fibroid volume all showed significant improvement. Eight of the participants experienced adverse events that resolved without sequelae and none required subsequent therapy.

See the European Journal of Obstetrics & Gynecology and Reproductive Biology >

See media coverage of this study in Contemporary OB/GYN >

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