Multicenter Prospective Study on Transvaginal Radiofrequency Ablation of Uterine Fibroids: Efficacy, Safety, and...

To evaluate the reproducibility, mid-term efficacy, and safety of transvaginal ultrasound-guided radiofrequency (RF) ablation of uterine myomas among multiple centers and operators.

Prospective multicenter observational study.

Eleven public and private hospitals in Spain.

A total of 393 women with symptomatic uterine myomas treated between May 2021 and June 2024.

All procedures were performed using a standardized transvaginal RF ablation protocol (VIVA RF System, STARmed Co., Goyang, South Korea) after formal training of participating gynecologists.

Clinical and ultrasonographic data were prospectively collected at baseline, 12, and 24 months. The mean baseline myoma volume was 35.2 ± 45.0 cm³, decreasing to 12.2 ± 24.2 cm³ at 12 months (65.3% reduction, p <.05). Symptom severity score (SSS) improved from 25.6 ± 7.7 to 15.5 ± 6.0 at 12 months and 14.7 ± 5.6 at 24 months (p <.05). The overall complication rate was 5%, with 90% classified as Clavien-Dindo I. Smaller initial myoma volume (β = -0.18; 95% CI, -0.35 to -0.02; p = .031) and patient age ≥ 41 years (β = +14.7; 95% CI, 0.40-29.0; p = .044) were independent predictors of greater volume reduction. Intercenter analysis revealed significant differences only in 1 hospital, confirming high reproducibility across operators.

Transvaginal RF ablation is a safe, effective, and reproducible uterus-preserving treatment for symptomatic myomas. Standardized training and adherence to unified procedural protocols may further optimize outcomes and minimize variability among centers.