Evaluation of the clinical and cost-effectiveness of transcervical ultrasound-guided radiofrequency ablation of leiomyomas (ESONATA): a prospective comparative cohort study

OBJECTIVE: Intrauterine ultrasound-guided radiofrequency ablation with the Sonata® System is a minimally invasive option for uterine fibroids. Currently, comparative studies and cost-effectiveness data are lacking. This three-arm study aims to evaluate the clinical and cost-effectiveness of the Sonata® system versus laparoscopic or laparotomic myomectomy and laparoscopic hysterectomy. DESIGN/SETTING/PARTICIPANTS/INTERVENTIONS: A single-center prospective comparative cohort study of 96 participants was conducted with 18 months of follow-up. Participants were allocated, based on patient preference, to Sonata treatment, myomectomy, or hysterectomy. The primary outcome was return to work (RTW). Secondary outcomes included symptom severity score (SSS), health-related quality of life (HRQoL), reintervention or redo rate, complications, satisfaction, and recommendation. For the economic evaluation, HRQoL, resource use and costs were evaluated after 12 months. RESULTS: Median RTW after Sonata treatment was 3.0 days (IQR 1.2-4.8), compared to 47.0 days (IQR 42.3-51.7) for myomectomy and 45.0 days (IQR 36.5-53.5) for hysterectomy. At 12 months SSS decreased by 22.2, 24.9, and 47.2 points for Sonata, myomectomy, and hysterectomy respectively. Correspondingly, HRQoL increased significantly by 31.1, 25.2, and 48.7 points. Surgical reintervention rates at 18 months were 27.3% for Sonata and 6.3% for myomectomy. Surgical redo rate following Sonata treatment was 24.2%. No complications were reported after Sonata, 11 complications were related to myomectomy and 2 to hysterectomy. After 18 months, satisfaction rates were slightly higher in the myomectomy (96%) and hysterectomy (97%) groups, compared to the Sonata group (85%). At 18 months, 97% of participants would recommend Sonata and hysterectomy, while 96% would recommend myomectomy. The economic evaluation showed the highest HRQoL gain after hysterectomy but at the highest cost. Conversely, myomectomy was less favorable than Sonata, as it yielded less HRQoL gain at a higher cost. CONCLUSION: Sonata leads to faster RTW compared to myomectomy and hysterectomy. SSS and HRQoL significantly improve following all treatments. Sonata is a cost-effective option compared to myomectomy. Although Sonata yields less HRQoL gain than hysterectomy, it is a lower-cost, uterus-preserving option, making it particularly valuable for premenopausal women. Despite a higher reintervention and redo rate, Sonata achieves high levels of patient satisfaction and recommendation.