title: Bipolar versus balloon endometrial ablation in the office: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the effectiveness of bipolar radiofrequency (Novasure®) ablation and balloon endometrial ablation (Thermablate®).
  
  
  METHODS
  We performed a multi-center double blind, randomized controlled trial in three hospitals in The Netherlands. Women with heavy menstrual bleeding were randomly allocated to bipolar or balloon endometrial ablation, performed in the office, using a paracervical block. The primary outcome was amenorrhea. Secondary outcome measures were pain, satisfaction, quality of life and reintervention.
  
  
  RESULTS
  104 women were randomized into the bipolar (52) and balloon (52) groups. After 12 months amenorrhea rates were 56% (29/52) in the bipolar group and 23% (12/52) in the balloon group (relative risk (RR) 0.6, 95% confidence interval (CI) 0.4-0.8). The mean visual analog pain score of the total procedure was 7.1 in the bipolar group and 7.4 in the balloon group (P<.577). 87% (45/52) of the patients in the bipolar group were satisfied with the result of the treatment versus 69% (36/52) in the balloon group (RR 0.44, 95% CI 0.2-0.97). The reintervention rates were 5/52 (10%) in the bipolar group and 6/52 (12%) in the balloon group (RR 1.02, 95% CI 0.9-1.2). Quality of life (Shaw score) improved over time (P<.001) and was significantly higher in the bipolar group at 12 months follow-up (P=.025).
  
  
  CONCLUSIONS
  In the treatment of heavy menstrual bleeding, bipolar radiofrequency endometrial ablation is superior to balloon endometrial ablation as an office procedure in amenorrhea rate, patient satisfaction and quality of life.
authors.affiliation: Department of Obstetrics & Gynecology, Máxima Medical Centre, Veldhoven, The Netherlands. Electronic address: josienp@hotmail.com.
authors.forename: Josien P M
authors.initials: JP
authors.lastname: Penninx
authors.affiliation: Department of Obstetrics & Gynecology, Máxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: Malou C
authors.initials: MC
authors.lastname: Herman
authors.affiliation: Department of Obstetrics & Gynecology and GROW-School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: Roy F P M
authors.initials: RF
authors.lastname: Kruitwagen
authors.affiliation: Department of Obstetrics & Gynecology, Twee Steden Ziekenhuis, Tilburg, The Netherlands.
authors.forename: Annette J F
authors.initials: AJ
authors.lastname: Ter Haar
authors.affiliation: Department of Obstetrics & Gynecology, Máxima Medical Centre, Veldhoven, The Netherlands; The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Australia.
authors.forename: Ben W
authors.initials: BW
authors.lastname: Mol
authors.affiliation: Department of Obstetrics & Gynecology, Máxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: Marlies Y
authors.initials: MY
authors.lastname: Bongers
mesh_terms: D000328:Adult; D017115:Catheter Ablation / Q000379:methods*; D004311:Double-Blind Method; D055356:Endometrial Ablation Techniques / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome
keywords: Balloon; Bipolar; Endometrial ablation; Office; Paracervical block