Page 38 - EVALUATION OF TREATMENT FOR HEAVY MENSTRUAL BLEEDING by Herman, Malou

Chapter 9
Chapter 4 evaluates the results 10 years after a randomised controlled trial comparing the effectiveness of two second-generation ablation techniques: bipolar radiofrequency impedance controlled endometrial ablation (Novasure®) and balloon endometrial ablation (Thermachoice®). A follow-up questionnaire was sent to women 10 years after randomization. Main outcome measures were amenorrhoea rates, re-intervention and patient satisfaction. 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 (RR 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 (RR 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 (RR 1.1, 95% CI 0.82–1.2).
This study concludes that ten years after treatment, the superiority of bipolar ablation over balloon ablation in the treatment of heavy menstrual bleeding is no longer evident. Although amenorrhea was the primary outcome in the initial study, for the long-term follow-up, the satisfaction rate and the hysterectomy rate are more useful for the evaluation of these ablation techniques. As we found that most re-interventions took place during the first 5 years after treatment, we conclude that evaluating outcome measures after short-term follow-up could help to predict long-term success in terms of the need for re-intervention.
Evaluating patient preference and effectiveness of LNG-IUS and endometrial ablation in the treatment of heavy menstrual bleeding Usual care in the Netherlands implies two strategies for the treatment of heavy menstrual bleeding if drug therapy fails: the LNG-IUS and endometrial ablation. Chapter 5 proposes a multicenter randomised controlled trial in which these two strategies are compared in the treatment of heavy menstrual bleeding. The LNG-IUS can be applied easily by the general practitioner (GP) and is effective at reducing the amount of blood loss; however, it has considerable discontinuation rates due to side effects, such as irregular bleeding (spotting). The contraceptive effect of the LNG-IUS is advantageous, but it has to be replaced every five years. On the other hand, removing the LNG-IUS is relatively simple and after that women regain their normal physiology. The alternative strategy is endometrial ablation, which is also very effective at decreasing menstrual bleeding and shows
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