Effectiveness of Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas Compared With Myomectomy on Symptoms and Health-Related Quality of Life.

OBJECTIVE

To compare changes in symptom severity and health-related quality of life (HRQOL) after laparoscopic radiofrequency ablation (RFA) and myomectomy for the treatment of uterine leiomyomas.

METHODS

The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is a multicenter prospective cohort study of premenopausal women with symptomatic uterine leiomyomas undergoing laparoscopic RFA or myomectomy. Participants completed validated patient-reported outcome measures, including the UFS-QOL (Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire), at baseline and at 6-month intervals for up to 24 months after treatment. Changes from baseline in symptom severity and HRQOL domains were evaluated with propensity-weighted repeated-measures models to account for potential treatment selection bias and within-subject correlation over time.

RESULTS

A total of 401 participants were included (237 with RFA, 164 with myomectomy) with a mean±SD age of 39.2±6.9 years; 53% (n=210) identified as Black. Three hundred eighty-six participants provided follow-up outcome measures. Participants had a median of two leiomyomas (interquartile range 1-15) and substantial baseline symptom burden, with a mean±SD SSS (Symptom Severity Scale) score of 61±23 and HRQOL score of 41±26). Both treatment groups demonstrated significant and sustained improvements in symptoms and HRQOL over the 24-month follow-up period. In propensity-weighted models, the myomectomy group experienced greater reductions in SSS (-33.0 vs -27.7, difference -5.27, P=.028) and greater improvements in HRQOL (34.92 vs 28.29, difference -6.62, P=.011) compared with RFA. These differences were below the threshold for minimal clinically important changes in SSS (10 points) and HRQOL (20 points). At interim 6-month assessments, myomectomy showed modestly greater improvements in functional subdomains such as activities, control, and self-consciousness; however, these differences diminished and were not observed at 24 months.

CONCLUSION

Both laparoscopic RFA and myomectomy significantly improve leiomyoma-related symptoms and HRQOL over 2 years. Although myomectomy demonstrates slightly greater improvements in some domains, overall differences between treatments are small and do not exceed the threshold change scores for clinically important differences at 2 years of follow-up.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT0210094.