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

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• 作者：Agnaldo L. Silva-Filho ; ^{agnaldo.ufmg@gmail.com} ; Francisco de A.N. Pereira ; Sé ; rgio S. de Souza ; Luciano F. Loures ; Ana Paula C. Rocha ; Carolina N. Valadares ; Má ; rcia M. Carneiro ; Rubens L.C. Tavares ; Aroldo F. Camargos
• 关键词：Heavy menstrual bleeding ; Thermal balloon ablation ; Thermal balloon ; Levonorgestrel intrauterine system ; Endometrium
• 刊名：Contraception
• 出版年：2013
• 出版时间：April, 2013
• 年：2013
• 卷：87
• 期：4
• 页码：409-415
• 全文大小：551 K

文摘

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 ¦Ö² 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 (¡À SD) levels in comparison to the TBA group (14.1¡À0.3 vs 12.7¡À0.4 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.