ABSTRACT: Previous randomized controlled trials compared bipolar endometrial ablation and balloon ablation for the treatment of heavy menstrual bleeding (HMB). At both 12 months and 5 years after treatment, bipolar endometrial ablation was superior to balloon ablation.
This follow-up randomized controlled trial compared the effectiveness of these 2 endometrial ablation techniques in women with HMB at 10 years after treatment. The trial was conducted at a teaching hospital in the Netherlands. Subjects were 126 premenopausal women with HMB: 83 were randomized to the bipolar group and 43 to the balloon group. Women completed a follow-up questionnaire 10 years after randomization. The primary study outcome measures were amenorrhea rates, reintervention, and patient satisfaction.
At the 10-year follow-up, the response rate was 83% (69/83) in the bipolar group and 81% (35/43) in the balloon group. Amenorrhea rates at 10 years were 73% (50/69) in the bipolar group and 66% (23/35) in the balloon group; the relative risk (RR) was 1.1, with a 95% confidence interval (CI) of 0.83 to 1.5. Twenty-three women required further treatment, 14 in the bipolar group and 9 in the balloon group (RR, 0.9; 95% CI, 0.63–1.3). Eight of the women required further treatment after 5 years, including 2 hysterectomies in the bipolar group. At 10 years, patient satisfaction in the bipolar group was 81% (56/69) compared with 77% (27/35) in the balloon group; the RR was 1.1, with a 95% CI of 0.82 to 1.2.
These data show that that the superiority of bipolar ablation over balloon ablation in the treatment of HMB observed at 1 and 5 years after initial treatment is no longer evident after 10 years.