title: 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).
  
  
  METHODS
  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 χ(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.
  
  
  CONCLUSIONS
  Five-year follow-up of HMB treatment with LNG-IUS was associated with higher efficacy and satisfaction ratings compared to TBA.
authors.affiliation: Department of Gynecology and Obstetrics, School of Medicine, Federal University of Minas Gerais, Minas Gerais 31.030-100, Brazil. agnaldo.ufmg@gmail.com
authors.forename: Agnaldo L
authors.initials: AL
authors.lastname: Silva-Filho
authors.forename: Francisco de A N
authors.initials: Fde A
authors.lastname: Pereira
authors.forename: Sérgio S
authors.initials: SS
authors.lastname: de Souza
authors.forename: Luciano F
authors.initials: LF
authors.lastname: Loures
authors.forename: Ana Paula C
authors.initials: AP
authors.lastname: Rocha
authors.forename: Carolina N
authors.initials: CN
authors.lastname: Valadares
authors.forename: Márcia M
authors.initials: MM
authors.lastname: Carneiro
authors.forename: Rubens L C
authors.initials: RL
authors.lastname: Tavares
authors.forename: Aroldo F
authors.initials: AF
authors.lastname: Camargos
mesh_terms: D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000097:blood; D055356:Endometrial Ablation Techniques / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D006979:Hyperthermia, Induced; D007044:Hysterectomy; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000097:blood; D008595:Menorrhagia / Q000097:blood / Q000523:psychology / Q000628:therapy*; D017211:Treatment Failure
chemical_list: D003271:Contraceptive Agents, Female; D006454:Hemoglobins; D016912:Levonorgestrel