title: Five-year follow up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation.
abstract: OBJECTIVE
  We have previously reported that NovaSure was more effective than balloon ablation at 12 months follow up in the treatment of menorrhagia. In this paper, we report the 5-year outcome of this study. The objective was to evaluate amenorrhoea rates, hysterectomy rate, and quality of life associated with the bipolar impedance-controlled endometrial ablation technique (NovaSure) in comparison with balloon ablation technique (ThermaChoice) at 5 years after administration.
  
  
  METHODS
  Double-blind randomised controlled trial, 2:1 randomisation NovaSure versus ThermaChoice.
  
  
  METHODS
  A teaching hospital with 500 beds in The Netherlands.
  
  
  METHODS
  A total of 126 premenopausal women suffering from menorrhagia with a pictorial blood loss assessment count > or = 150 without intracavitary abnormalities.
  
  
  METHODS
  Women were randomly allocated to bipolar radio-frequency ablation and balloon ablation in a 2:1 ratio.
  
  
  METHODS
  The main outcome measures were amenorrhoea rate, hysterectomies, and health-related quality of life (HRQol) as reported at 5 year follow up.
  
  
  RESULTS
  At 5 years of follow up, the total response rate was 96% in the bipolar group and 90% in the balloon group. Amenorrhoea was reported in the bipolar group by 48% of women and in the balloon arm by 32% (relative risk 1.6 [.93-2.6]). There were eight women in the bipolar group (9.8%) and five in the balloon group (12.9%) who had undergone a hysterectomy. Furthermore, there was a significant equal improvement of HRQoL over time in both groups.
  
  
  CONCLUSIONS
  At 5 years follow up, bipolar thermal ablation was superior over balloon ablation in the treatment of menorrhagia.
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: J H
authors.initials: JH
authors.lastname: Kleijn
authors.forename: R
authors.initials: R
authors.lastname: Engels
authors.forename: P
authors.initials: P
authors.lastname: Bourdrez
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
authors.forename: M Y
authors.initials: MY
authors.lastname: Bongers
mesh_terms: D000568:Amenorrhea / Q000209:etiology*; D017115:Catheter Ablation / Q000379:methods*; D002404:Catheterization / Q000379:methods; D004311:Double-Blind Method; D004717:Endometrium / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy / Q000706:statistics & numerical data*; D008595:Menorrhagia / Q000601:surgery*; D017060:Patient Satisfaction; D017697:Premenopause; D011788:Quality of Life; D016896:Treatment Outcome