Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for heavy menstrual bleeding

Abstract

Objective: Previously, we have reported that, at both 12 months and 5 years after treatment, bipolar endometrial ablation is superior to balloon ablation in the treatment of heavy menstrual bleeding. In this article, we evaluate the results at 10 years after these interventions. Design: Ten-year follow-up of a double-blind randomised controlled trial. Setting: A teaching hospital in the Netherlands. Population: Premenopausal women suffering from heavy menstrual bleeding. Method: A follow-up questionnaire was sent to women 10 yearsafter randomisation for bipolar ablation and balloon ablation (2 : 1 ratio). Main outcome measures: Amenorrhoea rates, re-intervention and patient satisfaction. Results: At 10 years of follow-up, the response rate was 69/83 (83%) in the bipolar group and 35/43 (81%) in the balloon group. Amenorrhoea rates were 50/69 (73%) in the bipolar group and 23/35 (66%) in the balloon group [relative risk, 1.1 (95% CI, 0.83–1.5)]. Further treatment following initial ablation was reported in 21 cases, 14 in the bipolar group and nine in the balloon group [relative risk, 0.9 (95% CI, 0.63–1.3)]. Eight of these women required further treatment after 5 years, including two hysterectomies. Patient satisfaction in the bipolar group was 81% (56/69) compared with 77% (27/35) in the balloon group [relative risk, 1.1 (95% CI, 0.82–1.2)]. Conclusion: Ten years after treatment, the superiority of bipolarablation over balloon ablation in the treatment of heavy menstrual bleeding was no longer evident.