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

Objective

To report 2-year results of sonography-guided transcervical fibroid ablation (TFA) using the Sonata® system in women with symptomatic uterine fibroids.

Design

This is a prospective multicenter single-arm interventional trial.

Methods

Premenopausal women with up to 10 clinically relevant uterine fibroids, each ranging from 1 to 5 cm in diameter, were treated with sonography-guided TFA on an outpatient basis and returned for regular follow-up visits for 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.

Results

Among 147 enrolled women, 125 (85%) returned for follow-up at 2 years. Compared with baseline, symptom severity decreased from 55 ± 19 to 24 ± 18 (p < 0.001), health-related quality of life increased from 40 ± 21 to 83 ± 19 (p < 0.001), and EuroQol 5-Dimension scores increased from 0.72 ± 0.21 to 0.89 ± 0.14 (p < 0.001). Overall treatment satisfaction at 2 years was 94%. The mean percentage of missed work time, overall work impairment, and activity impairment significantly decreased at follow-up. Through 2 years, surgical reintervention for heavy menstrual bleeding was performed in 5.5% of patients. One singleton pregnancy occurred with a normal peripartum outcome.

Conclusions

TFA treatment with the Sonata system provides significant clinical improvement through 2 years postablation, with a low incidence of surgical reintervention. Other favorable outcomes included a rapid return to work and substantial improvements in quality of life, symptom severity, work productivity, and activity levels.