title: Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial.
abstract: OBJECTIVE
  To estimate the feasibility of local anesthetic endometrial ablation in the office using bipolar radiofrequency endometrial ablation or thermal balloon ablation technologies and to estimate which procedure alleviates heavy menstrual bleeding and improves quality of life more effectively.
  
  
  METHODS
  A single-center, single-blind, randomized controlled trial was conducted based in an office hysteroscopy clinic in a university teaching hospital. Eighty-one women with heavy menstrual bleeding without significant intracavity pathology were randomly allocated to bipolar radiofrequency endometrial ablation or thermal balloon ablation in an office setting, avoiding use of general anesthesia or conscious sedation. The primary outcome assessed was the rate of amenorrhea at 6 months after treatment. Secondary outcomes included procedure-related data (feasibility, pain, acceptability, complications) and health-related quality of life.
  
  
  RESULTS
  Amenorrhea rates were higher at 6 months after surgery with bipolar procedures, but not statistically significant (39% compared with 21%, risk ratio 1.9, 95% confidence interval 0.9-4.3, P=.1). All bipolar procedures were successfully completed, whereas the treatment cycle was not completed in 2 of 39 (5%) balloon procedures (P>.1) because of patient discomfort. The office bipolar procedure was significantly shorter, by 6.2 minutes on average (P<.001), and associated with more complete coverage of the endometrial surface (88% compared with 58%, P=.002). Health-related quality of life was significantly improved after both treatments.
  
  
  CONCLUSIONS
  Office endometrial ablation using the bipolar radiofrequency or thermal balloon procedures is feasible and effective. The bipolar procedure was significantly quicker and achieved a greater degree of endometrial destruction than the thermal balloon, although there was no significant difference in amenorrhea rates at 6 months.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357.
  
  
  METHODS
  I.
authors.affiliation: From the Birmingham Women's Hospital, Birmingham, United Kingdom; and the Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: T Justin
authors.initials: TJ
authors.lastname: Clark
authors.forename: Nadia
authors.initials: N
authors.lastname: Samuel
authors.forename: Sadia
authors.initials: S
authors.lastname: Malick
authors.forename: Lee J
authors.initials: LJ
authors.lastname: Middleton
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
authors.forename: Janesh K
authors.initials: JK
authors.lastname: Gupta
mesh_terms: D000328:Adult; D055356:Endometrial Ablation Techniques; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008595:Menorrhagia / Q000628:therapy*; D008875:Middle Aged; D016896:Treatment Outcome