Transcervical Radiofrequency Ablation of Symptomatic Uterine Fibroids: 2-Year Results of the Sonata Pivotal Trial

Abstract

Study Objective To report 2-year results of sonography-guided transcervical radiofrequency (RF) ablation using the Sonata® system in women with symptomatic uterine fibroids. Design Prospective, longitudinal, multicenter, single-arm trial. Setting 22 clinical sites (21 in the US and 1 in Mexico). Patients or Participants Premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to fibroids. Interventions Ultrasound-guided transcervical, intrauterine radiofrequency ablation was performed on up to 10 clinically relevant uterine fibroids, each ranging from 1 to 5 cm in diameter. Patients were treated on an outpatient basis and returned for regular follow-up visits over 2 years. Assessed outcomes included changes in symptom severity, heath-related quality of life, general health status, work and activity limitations, treatment satisfaction, adverse events, surgical reintervention, and occurrence of pregnancy and associated outcomes. Measurements and Main Results Among 147 enrolled women, 125 (85%) returned for follow-up at 2 years. Compared to baseline, symptom severity decreased from 55±19 to 23±19 (p Conclusion Treatment with the Sonata system provides significant clinical improvement through 2 years post-ablation, with a low incidence of surgical reintervention. Other favorable outcomes included substantial improvements in quality of life, symptom severity, work productivity and activity levels.