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

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 > or = 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.