Key Study Highlights:
- Prospective multicenter study
- Conducted across 11 hospitals
- Follow up at 12 and 24 months
- TV-RFA with VIVA RF System
- 393 patients treated with transvaginal RF ablation
- Significant symptom improvement and fibroid volume reduction observed
Background
- Uterine fibroids are the most common benign tumors of the female reproductive system and are a frequent cause of heavy menstrual bleeding, pelvic pain, and infertility.
- Although hysterectomy and myomectomy remain effective surgical treatments, their invasive nature has driven the development of minimally invasive alternatives that preserve the uterus.
- Radiofrequency ablation (RFA) has emerged as a safe and effective technique capable of reducing fibroid volume and improving symptoms while allowing uterine preservation.
- Ultrasound-guided transvaginal RFA is a minimally invasive approach that allows treatment of fibroids that may be difficult to access through other routes and enables rapid recovery with no surgical incisions.
Study objective
To evaluate the reproducibility, mid-term efficacy, and safety of transvaginal ultrasound-guided radiofrequency ablation (TV-RFA) for symptomatic uterine fibroids across multiple centers and operators.
Methods and procedures
- Prospective multicenter observational study conducted in 11 hospitals in Spain.
- Participating gynecologists underwent standardized procedural training before enrolling patients.
- Data were collected prospectively beginning with each physician’s first clinical case in real-world practice.
- 393 women with symptomatic uterine fibroids treated between May 2021 and June 2024.
- All procedures were performed using the VIVA RF System (STARMED) with a 17-gauge coagulation needle and maximum power output of 100 W.
- A moving-shot ablation technique was used, delivering successive 1-cm ablations to treat the fibroid. Procedures were performed on an outpatient basis, with antibiotic prophylaxis administered prior to treatment.
Indications for treatment
- Heavy menstrual bleeding: 73.8%
- Infertility: 20.7%
- Compressive symptoms: 5.2%
Follow-Up
Clinical and ultrasonographic outcomes were assessed at baseline, 12 months and 24 months
Safety
The procedure demonstrated a low complication rate of approximately 5%
Results
Mean fibroid volume decreased from 35.2 cm³ at baseline to 12.2 cm³, representing a 65.3% reduction. Symptom Severity Score also improved substantially, declining from 25.6 to 15.5, indicating meaningful relief of fibroid-related symptoms. In addition, the number of heavy menstrual bleeding days decreased from 4.4 to 1.6 days, reflecting a notable improvement in menstrual outcomes.
Conclusions
Transvaginal radiofrequency ablation with the VIVA RF system is a safe, effective, and reproducible minimally invasive treatment for symptomatic uterine fibroids. The multicenter results demonstrate significant fibroid volume reduction, substantial improvement in patient symptoms, and a low complication rate.
Reference
Santalla-Hernandez, A., Gomez-Gutierrez-Solana, I., DelaTorre-Bulnes, M., Marín-Martínez, M. E., Molina-González, D., Gadea-Niñoles, M. E., ... & Naveiro-Fuentes, M. (2026). Multicenter Prospective Study on Transvaginal Radiofrequency Ablation of Uterine Fibroids: Efficacy, Safety, and Reproducibility. Journal of minimally invasive gynecology.
DOi: https://linkinghub.elsevier.com/retrieve/pii/S1553465026000543
Key Study Highlights:
Background
Study objective
To evaluate the reproducibility, mid-term efficacy, and safety of transvaginal ultrasound-guided radiofrequency ablation (TV-RFA) for symptomatic uterine fibroids across multiple centers and operators.
Methods and procedures
Indications for treatment
Follow-Up
Clinical and ultrasonographic outcomes were assessed at baseline, 12 months and 24 months
Safety
The procedure demonstrated a low complication rate of approximately 5%
Results
Mean fibroid volume decreased from 35.2 cm³ at baseline to 12.2 cm³, representing a 65.3% reduction. Symptom Severity Score also improved substantially, declining from 25.6 to 15.5, indicating meaningful relief of fibroid-related symptoms. In addition, the number of heavy menstrual bleeding days decreased from 4.4 to 1.6 days, reflecting a notable improvement in menstrual outcomes.
Conclusions
Transvaginal radiofrequency ablation with the VIVA RF system is a safe, effective, and reproducible minimally invasive treatment for symptomatic uterine fibroids. The multicenter results demonstrate significant fibroid volume reduction, substantial improvement in patient symptoms, and a low complication rate.
Reference
Santalla-Hernandez, A., Gomez-Gutierrez-Solana, I., DelaTorre-Bulnes, M., Marín-Martínez, M. E., Molina-González, D., Gadea-Niñoles, M. E., ... & Naveiro-Fuentes, M. (2026). Multicenter Prospective Study on Transvaginal Radiofrequency Ablation of Uterine Fibroids: Efficacy, Safety, and Reproducibility. Journal of minimally invasive gynecology.
DOi: https://linkinghub.elsevier.com/retrieve/pii/S1553465026000543