Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up

Abstract

Objective: To confirm the results of an earlier study assessing the safety and efficacy of a laparoscopic radiofrequency volumetric thermal ablation (RFVTA) system among women with symptomatic myomas.

Methods: In a prospective study at the Hospital of Francisco Marroquin University, Guatemala City, consecutive premenopausal women with symptomatic myomas seeking uterine-sparing treatment were enrolled between August 2008 and July 2011. The women were treated by RFVTA. Uterine fibroid symptom and health-related quality-of-life (UFS-QOL) questionnaires were completed at 0, 3, 6, and 12 months.

Results: Among 114 women screened, 36 were enrolled (ages 33-51 years), and 35 were followed for 12 months. Symptom severity scores reduced significantly (P<0.05): baseline (63.3), 3 months (23.1), 6 months (15.4), 12 months (9.6). Health-related quality-of-life scores improved significantly (P<0.05): baseline (37.3), 3 months (79.9), 6 months (85.1), 12 months (87.7). The mean ± SD difference in uterine volume from baseline (215.2 ± 117.9 cm(3)) to 12 months (167.0 ± 120.8 cm(3)) was 48.2 cm(3) (95% CI: -22.8 to 119.2; P=0.192). Nine adverse events among 8 individuals were minor and unrelated to the procedure.

Conclusion: RFVTA of fibroids resulted in significantly improved symptom severity and quality-of-life scores and provides an outpatient uterine-sparing option for treatment of myomas.