Five-year follow up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation

Abstract

Objective: We have previously reported that NovaSure® was more effective than balloon ablation at 12 months follow up in the treatment of menorrhagia. In this paper, we report the 5-year outcome of this study. The objective was to evaluate amenorrhoea rates, hysterectomy rate, and quality of life associated with the bipolar impedance-controlled endometrial ablation technique (NovaSure) in comparison with balloon ablation technique (ThermaChoice®) at 5 years after administration. Design: Double-blind randomised controlled trial, 2:1 randomisation NovaSure versus ThermaChoice. Setting: A teaching hospital with 500 beds in the Netherlands. Population: A total of 126 premenopausal women suffering from menorrhagia with a pictorial blood loss assessment count ≥150 without intracavitary abnormalities. Methods: Women were randomly allocated to bipolar radio-frequency ablation and balloon ablation in a 2:1 ratio. Main outcome measures: The main outcome measures were amenorrhoea rate, hysterectomies, and health-related quality of life (HRQol) as reported at 5 year follow up. Results: At 5 years of follow up, the total response rate was 96% in the bipolar group and 90% in the balloon group. Amenorrhoea was reported in the bipolar group by 48% of women and in the balloon arm by 32% (relative risk 1.6 [.93–2.6]). There were eight women in the bipolar group (9.8%) and five in the balloon group (12.9%) who had undergone a hysterectomy. Furthermore, there was a significant equal improvement of HRQoL over time in both groups. Conclusions: At 5 years follow up, bipolar thermal ablation was superior over balloon ablation in the treatment of menorrhagia.