Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial

Objective: To evaluate the efficacy and safety of transvaginal high-intensity focused ultrasound (vHIFU) therapy in women with symptomatic uterine leiomyomas. Methods: This first-in-human, two-center, prospective, unblinded, single-arm trial was performed in the Republic of Korea from December 2017 to February 2019. Premenopausal women with symptomatic, contrast-enhanced uterine leiomyomas with a diameter <= 5 cm were eligible. Under sedation or monitored anesthesia, leiomyomas were ablated with vHIFU under ultrasound guidance. The primary endpoint was the non-perfused volume (NPV) ratio measured immediately after therapy. Secondary endpoints were changes in Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scores, dysmenorrhea visual analog scale (VAS), uterine leiomyoma volume, rate of subsequent therapy, and treatment-emergent adverse events (TEAE). Results: Thirty-five women were screened; 13 women were enrolled and underwent vHIFU therapy for 33 uterine leiomyomas. NPV ratios were 0.76 +/- 0.27 (mean +/- SD); the lower limit of a one-sided 97.5 % confidence interval was 0.67, surpassing the non-inferiority cut-off of 0.50. UFS-QOL scores (symptom severity score, median, baseline: 66.60, 3-month follow-up: 32.85; p = 0.0010; health related quality of life score, median, baseline: 41.40, 3-month follow-up: 73.30; p = 0.0010) and dysmenorrhea VAS (mean, baseline: 50.92, 3-month follow-up: 20.67; p = 0.0019) improved significantly. Volume of uterine leiomyoma was reduced (median, baseline: 8.10 cm(3), 3-month follow=-up: 5.30 cm(3); p < 0.0001), and none received subsequent therapy. Twenty-six TEAEs from 8 participants were observed, and all TEAEs were resolved without sequelae. Conclusion: vHIFU therapy exhibited promising efficacy and safety and might be considered as a treatment option for women with symptomatic uterine leiomyomas. (C) 2020 Elsevier B.V. All rights reserved.

Automated summary

This study aimed to evaluate the efficacy and safety of transvaginal high-intensity focused ultrasound (vHIFU) therapy in women with symptomatic uterine leiomyomas. The results showed promising efficacy in reducing symptoms severity, improving quality of life, and decreasing dysmenorrhea pain. The reduction in uterine leiomyoma volume and absence of subsequent therapy needs were also positive outcomes.