Journal of minimally invasive gynecology · 2026
Multicenter Prospective Study on Transvaginal Radiofrequency Ablation of Uterine Fibroids: Efficacy, Safety, and Reproducibility.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Santalla-Hernandez Angel, Gomez-Gutierrez-Solana Iván, DelaTorre-Bulnes María, Marín-Martínez María Eugenia, Molina-González Domingo, Gadea-Niñoles María Esperanza, Lopez-Lopez Antonia María, Pelayo-Delgado Irene, Torrijo-Rodrigo Cristina, Lara-Peñaranda Rosario, José Palomo-Viciana María, Naveiro-Fuentes Mariña
Аннотация
OBJECTIVE: To evaluate the reproducibility, mid-term efficacy, and safety of transvaginal ultrasound-guided radiofrequency (RF) ablation of uterine myomas among multiple centers and operators.
DESIGN: Prospective multicenter observational study.
SETTING: Eleven public and private hospitals in Spain.
PATIENTS: A total of 393 women with symptomatic uterine myomas treated between May 2021 and June 2024.
INTERVENTIONS: 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.
MEASUREMENTS AND MAIN RESULTS: 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.
CONCLUSION: 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.
DESIGN: Prospective multicenter observational study.
SETTING: Eleven public and private hospitals in Spain.
PATIENTS: A total of 393 women with symptomatic uterine myomas treated between May 2021 and June 2024.
INTERVENTIONS: 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.
MEASUREMENTS AND MAIN RESULTS: 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.
CONCLUSION: 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.