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

Abstract 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)...

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Published in:	Contraception (Stoneham) Vol. 87; no. 4; pp. 409 - 415
Main Authors:	Silva-Filho, Agnaldo L, Pereira, Francisco de A.N, de Souza, Sérgio S, Loures, Luciano F, Rocha, Ana Paula C, Valadares, Carolina N, Carneiro, Márcia M, Tavares, Rubens L.C, Camargos, Aroldo F
Format:	Journal Article
Language:	English
Published:	New York, NY Elsevier Inc 01-04-2013 Elsevier
Subjects:	Adult Biological and medical sciences Contraceptive Agents, Female - administration & dosage Contraceptive Agents, Female - blood Endometrial Ablation Techniques - methods Endometrium Female Female genital diseases Follow-Up Studies Genital system. Reproduction Gynecology. Andrology. Obstetrics Heavy menstrual bleeding Hemoglobins - metabolism Humans Hyperthermia, Induced Hysterectomy Intrauterine Devices, Medicated Levonorgestrel - administration & dosage Levonorgestrel - blood Levonorgestrel intrauterine system Medical sciences Menorrhagia - blood Menorrhagia - psychology Menorrhagia - therapy Non tumoral diseases Obstetrics and Gynecology Pharmacology. Drug treatments Thermal balloon Thermal balloon ablation Treatment Failure Levonorgestrel intrauterine system Heavy menstrual bleeding Thermal balloon Endometrium Thermal balloon ablation Menstruation disorders Levonorgestrel Ablation Hemorrhage Menorrhagia Female genital diseases Progestagen Randomization Treatment Active substance loaded intrauterine device Uterine diseases Contraceptive Comparative study
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Summary:	Abstract 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 χ2 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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	0010-7824 1879-0518
DOI:	10.1016/j.contraception.2012.11.004