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

摘要

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.