Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with the Sonata System after Three Years

Abstract

<h3>Study Objective</h3> To determine the longitudinal health outcomes of transcervical fibroid ablation (TFA) with the Sonata System on quality of life (QOL) as determined by quality-adjusted life years (QALYs) over 3 years. <h3>Design</h3> Prospective, controlled, multicenter interventional trial. <h3>Setting</h3> 22 Hospitals in the US (21) and Mexico (1). <h3>Patients or Participants</h3> 147 women who underwent TFA with the Sonata® System. <h3>Interventions</h3> TFA was used to ablate fibroids under clinical trial protocol. <h3>Measurements and Main Results</h3> Change in generic health status was assessed with the EQ-5D questionnaire (0 to 1 scale). Fibroid-specific QOL was measured on a 0 to 100 scale using the health-related quality of life (HRQL) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL). We determined the number of QALYs gained relative to baseline by calculating the area under the curve at each follow-up visit over 3 years. We additionally determined cumulative QALYs experienced at each interval during follow-up. The SONATA trial enrolled 147 women at 22 centers who received TFA for symptomatic uterine fibroids. Fibroid-specific QOL increased from 40±21 at baseline to 83±23 at 3 years (p<0.001). Generic QOL increased from 0.72±0.21 at baseline to 0.88±0.16 at 3 years (p<0.001). Comparing outcomes at 3 years relative to baseline, TFA resulted in 1.24±0.64 QALYs gained when calculated using fibroid-specific health utility scores and 0.49±0.61 QALYs gained when calculated using generic health utility scores. Cumulative QALYs experienced at 3 years as a percentage of perfect health were 82% when using fibroid-specific scores and 88% when using generic health scores. <h3>Conclusion</h3> Women treated by TFA with the Sonata System for symptomatic uterine fibroids reported durable improvements in generic and fibroid-specific QOL.