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

Objective We have previously reported that NovaSure(R) 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(R)) 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 radiofrequency 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.