Comparison of the clinical performance of NovaSure and ThermaChoice endometrial ablation

Abstract

Objective. To assess the anlenorrhea rates, satisfaction, quality of life and costs associated with the NovaSure procedure in comparison with ThemlaChoice balloon ablation. Design. Randomised, double-blind, study. Setting. Teaching Hospital. Patients. A total of 126 pre-menopansal women suffering from menorrhagia with the PBLAC > 150 or more. Interventions. NovaSure Bipolar radiofrequency ablation and ThermaChoice hot water balloon ablation. The NovaSure System consists of a 3-Dimensional Bipolar Device and RF Controller that enable endometrial ablation in an average of 90 seconds without the need for endometrial pretreatment. Them~aChoice consists of a latex balloon with a thermistor inside. Measurements and Main Results. PBAC, FSH levels and additional surgical interventions were evaluated at 3, 6, and 12 months. Quality of life evaluation was assessed before the intervention and at to 2 days, 2 weeks 3, 6 and 12 months after the ablation treatment. At 6-months followup the NovaSure group of patients reported an amenorrhoea rate of 54%, compared to 8% in the ThermaChoice group. At 12 months follow-up the an~enorrhea rate in the NovaSure arm was 55% compared to 12% in the ThermaChoice arm. No complications were associated with either procedure. An evaluation of direct and indirect costs was made. Conclusion. Clinical results demonstrate that the NovaSure System is an effective and safe second-generation device, yielding significantly higher amenorrhea and success rates when compared to ThermaChoice.