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

Abstract

Objective: To determine quality-adjusted life years (QALYs) over 3 years after transcervical fibroid ablation (TFA) with the Sonata System.

Methods: The SONATA trial was a prospective multicenter interventional trial that assessed the safety and efficacy of TFA for treatment of women with symptomatic uterine fibroids. Change in generic health status was assessed with the EuroQol 5-Dimension questionnaire (0-1 scale). Fibroid-specific quality of life (QOL) was measured on a 0 to 100 scale with the health-related quality of life subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL). The number of QALYs gained relative to baseline and cumulative QALYs were calculated using the area under the curve at each follow-up visit over 3 years.

Results: Among 147 women receiving TFA, fibroid-specific QOL increased from 40 ± 21 at baseline to 84 ± 19 at 1 year and 83 ± 23 at 3 years (p < 0.001). Generic QOL increased from 0.72 ± 0.21 at baseline to 0.89 ± 0.12 at 1 year and 0.88 ± 0.16 at 3 years (p < 0.001). Over 3 years, TFA resulted in 1.24 ± 0.64 QALYs gained when using fibroid-specific health utility scores and 0.49 ± 0.61 QALYs gained when using generic health utility scores. Cumulative QALYs experienced at 3 years as a percentage of perfect health were 82% with fibroid-specific scores and 88% with generic health scores.

Conclusions: Women treated by TFA with the Sonata System for symptomatic uterine fibroids reported durable improvements in generic and fibroid-specific QOL, as well as clinically meaningful increases in QALYs over 3 years. Clinical Trials.gov ID: NCT02228174. (J GYNECOL SURG 38:143).

Keywords: QALY; leiomyoma; quality of life; quality-adjusted life year; transcervical fibroid ablation; uterine fibroid.

Conflict of interest statement

K.R. is a consultant to Gynesonics, Inc., and CrossBay Medical, Inc., J.K.R. reports no conflicts of interest.

© Kelly Roy et al. 2022; Published by Mary Ann Liebert, Inc.

Figures

FIG. 1.

Change in HRQL subscale of the UFS-QOL Questionnaire over 3 years after TFA. Plotted values are mean and 95% confidence interval. Asterisk indicates statistically significant change relative to baseline (p < 0.05). HRQL, health-related quality of life; QOL, quality of life; TFA, transcervical fibroid ablation; UFS-QOL, Uterine Fibroid Symptom and Quality-of-Life.

FIG. 2.

Change in EQ-5D questionnaire score over 3 years after TFA. Plotted values are mean and 95% confidence interval. Asterisk indicates statistically significant change relative to baseline (p < 0.05). EQ-5D, EuroQol 5-Dimension.

FIG. 3.

Improvement in QOL from baseline after TFA reported in standardized MCID units with 95% confidence intervals. The MCID is 20 points for HRQL and 0.074 points for EQ-5D questionnaire. Treatment effects red background) indicate that it is unlikely that an appreciable number of patients will show a clinically important benefit, treatment effects between 0.5 and 1 MCID units (denoted by yellow background) indicate that a treatment may be beneficial to an appreciable number of patients, and treatment effects >1 MCID unit (denoted by green background) indicate that many patients may gain important benefits from treatment., MCID, minimal clinically important difference.

FIG. 4.

QALYs gained relative to baseline over 3 years after TFA. Plotted values are mean and 95% confidence interval. QALYs gained from baseline were calculated for generic QOL using the EQ-5D questionnaire and fibroid-specific QOL using the HRQL subscale of the UFS-QOL questionnaire. QALYs, quality-adjusted life years.

FIG. 5.

Cumulative QALYs over 3 years after TFA. Plotted values are mean and 95% confidence interval. Cumulative QALYs were calculated for generic QOL using the EQ-5D questionnaire and fibroid-specific QOL using the HRQL subscale of the UFS-QOL questionnaire.