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

Abstract

OBJECTIVE: To evaluate the reproducibility, mid-term efficacy, and safety of transvaginal ultrasound-guided radiofrequency (RF) ablation of uterine fibroids 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 fibroids treated between May 2021 and June 2024. INTERVENTIONS: All procedures were performed using a standardized transvaginal RF ablation protocol (VIVA RF System, STARmed Co.) 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 fibroid volume was 35.2 ± 45.0 cm³, decreasing to 12.2 ± 24.2 cm³ at 12 months (65.3% reduction, p<0.05). 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<0.05). The overall complication rate was 5%, with 90% classified as Clavien-Dindo I. Smaller initial fibroid volume (??=?-0.18; 95% CI, -0.35 to -0.02; p?=?0.031) and patient age ? 41 years (??=?+14.7; 95% CI, 0.40-29.0; p?=?0.044) were independent predictors of greater volume reduction. Inter-center analysis revealed significant differences only in one hospital, confirming high reproducibility across operators. CONCLUSION: Transvaginal RF ablation is a safe, effective, and reproducible uterus-preserving treatment for symptomatic fibroids. Standardized training and adherence to unified procedural protocols may further optimize outcomes and minimize variability among centers.