Five-year follow-up of levonorgestrel-releasing intrauterine system versus thermal balloon ablation for the treatment of heavy menstrual bleeding: a randomized controlled trial

Background: The study was conducted to compare 5-year follow-up of levonorgestrel-releasing intrauterine system (LNG-IUS) or thermal balloon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB). Study Design: A prospective, randomized controlled trial comparing LNG-IUS (n=30) and TBA (n=28) was performed. Hysterectomy rates, hemoglobin level, bleeding pattern, well-being status and satisfaction rates were assessed. Comparisons between groups were performed by chi(2) test and by unpaired and paired t tests. Results: After 5 years of follow-up, women treated with a TBA had higher rates of hysterectomy (24%) compared to the LNG-IUS group (3.7%) due to treatment failure (p=.039). Use of LNG-IUS resulted in higher mean hemoglobin (+/- SD) levels in comparison to the TBA group (14.1 +/- 0.3 vs 12.7 +/- 0.4 g/dL, p=.009). Menstrual blood loss was significantly higher in the TBA when compared to the LNG-IUS group (45.5% vs 0.0% p<.001). The psychological general well-being index scores were similar. Patient acceptability, perceived clinical improvement and overall satisfaction rates were significantly higher in women using LNG-IUS. Conclusion: Five-year follow-up of HMB treatment with LNG-IUS was associated with higher efficacy and satisfaction ratings compared to TBA. (C) 2013 Elsevier Inc. All rights reserved.