title: Clinical evaluation of long-term safety and effectiveness of a third-generation thermal uterine balloon therapy system for heavy menstrual bleeding.
abstract: OBJECTIVE
  To estimate the incidence of amenorrhea at 36 months after treatment using a third-generation thermal uterine balloon therapy (UBT) system and to compare it with the first-generation UBT system. The secondary objective was to estimate the effect of post-procedure curettage on patient outcomes at 36 months after endometrial ablation.
  
  
  METHODS
  Multicenter controlled study (Canadian Task Force classification I).
  
  
  METHODS
  Thirteen hospitals: 12 in the United States and 1 in Mexico.
  
  
  METHODS
  Two-hundred fifty premenopausal women aged at least 30 years with heavy menstrual bleeding not responsive to previous medical therapy for at least 3 months.
  
  
  METHODS
  After treatment with a third-generation thermal UBT system, patients were randomly assigned to receive post-procedure curettage (PPC) or no PPC.
  
  
  RESULTS
  Amenorrhea was estimated at 12 months using individual success defined by a pictorial blood loss assessment chart score of 0, and at 24- and 36-month follow-up by patient response of amenorrhea on a 5-point scale (amenorrhea, spotting, and light, normal, or excessive bleeding). In the intention-to-treat population, at 36 months after ablation, the amenorrhea rate was 26.8% with the third-generation UBT system, and 13.0% with the first-generation UBT system. Results by assigned intervention were 29.8% in the no PPC group vs 23.8% in the PPC group.
  
  
  CONCLUSIONS
  At extended 36-month follow-up, results were similar to the previously reported results at 1 year using prospectively defined matched-pair analysis, and demonstrated superiority in treating amenorrhea using the third-generation UBT system vs the first-generation UBT system.
authors: Center for Women's Health, Oakwood Hospital and Medical Center, Department of Obstetrics and Gynecology, Dearborn, Michigan 48123, USA. charles.cash@oakwood.org
authors: Charles
authors: C
authors: Cash
authors: Jose
authors: J
authors: Garza-Leal
authors: Arthur
authors: A
authors: Donovan
authors: Cyrus
authors: C
authors: Guidry
authors: Christine
authors: C
authors: Romanowski
authors: Bababhai
authors: B
authors: Patel
mesh_terms: D000328:Adult; D002404:Catheterization / Q000009:adverse effects / Q000379:methods*; D003475:Curettage; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects / Q000379:methods*; D007044:Hysterectomy; D057194:Intention to Treat Analysis; D008595:Menorrhagia / Q000628:therapy*; D008875:Middle Aged; D018579:Patient Selection; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013812:Therapeutics; D016896:Treatment Outcome