Improvement in health utility after transcervical radiofrequency ablation of uterine fibroids with the sonata system: Health utility after radiofrequency ablation

Eur J Obstet Gynecol Reprod Biol. 2018 May;224:175-180. doi: 10.1016/j.ejogrb.2018.03.053. Epub 2018 Mar 27.


Objectives: To establish the improvement in patient health utilities following treatment of symptomatic uterine fibroids with the Sonata™ System.

Study design: A prospective, single-arm trial was conducted in which 49 women in the United Kingdom, Netherlands and Mexico with fibroids were treated with transcervical, intrauterine ultrasound- guided radiofrequency ablation. The EQ-5D-3L system was utilized to collect patient health status at baseline, 3, 6, and, 12 months post-procedure. Patient-reported health states at each time point were converted into a health utility value using time-trade off methodology.

Results: In the overall cohort, patient health utility increased from a mean of 0.745 at baseline, to means of 0.838, 0.852, and 0.914 at 3 months, 6 months, and 12 months, respectively. The change from baseline at 12 months was significant. When stratified by country, the 12-month improvement in health utility remained significant for both the Mexican and Dutch cohorts.

Conclusions: Transcervical radiofrequency ablation of uterine fibroids with the Sonata System resulted in statistically significant 12-month improvements in health utility for the overall patient cohort and for the Mexican and Dutch sub-populations.

Keywords: Fertility preservation; Leiomyoma; Menorrhagia; Quality-adjusted life years (QALYs); Uterine myomectomy.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Ablation Techniques*
  • Adult
  • Female
  • Humans
  • Leiomyoma / surgery*
  • Longitudinal Studies
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Treatment Outcome
  • Uterine Neoplasms / surgery*