title: Randomized controlled trial of thermal balloon ablation versus vaginal hysterectomy for leiomyoma-induced heavy menstrual bleeding.
abstract: OBJECTIVE
  To compare the efficacy of thermal balloon ablation (TBA) with that of vaginal hysterectomy in the treatment of leiomyoma-induced heavy menstrual bleeding (HMB).
  
  
  METHODS
  An open-label randomized controlled trial was conducted between November 1, 2012, and October 31, 2014, in a tertiary care hospital in Delhi, India. Eligible women with HMB (aged ≥40 years, uterus size ≤14 weeks of pregnancy, leiomyoma ≤5 cm, uterocervical length ≤12 cm) were randomly assigned (1:1) to undergo TBA or vaginal hysterectomy using computer-generated random number tables. The primary outcome was the number of women in the TBA group with HMB 6 months after surgery. Analyses were by intention to treat.
  
  
  RESULTS
  Each group contained 20 women. No women in the TBA group had HMB at 6 months. Nineteen women were amenorrheic by 6 months and one was hypomenorrheic.
  
  
  CONCLUSIONS
  TBA can replace vaginal hysterectomy in some perimenopausal women with uterine leiomyomas. Clinical Trials Registry India: CTRI/2016/07/007119.
authors: Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India. Electronic address: drprachijain85@gmail.com.
authors: Prachi
authors: P
authors: Jain
authors: Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.
authors: Shalini
authors: S
authors: Rajaram
authors: Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.
authors: Bindiya
authors: B
authors: Gupta
authors: Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.
authors: Neerja
authors: N
authors: Goel
authors: Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.
authors: Himsweta
authors: H
authors: Srivastava
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced; D007045:Hysterectomy, Vaginal; D007194:India; D007889:Leiomyoma / Q000150:complications*; D008595:Menorrhagia / Q000601:surgery*; D008875:Middle Aged; D061646:Operative Time; D011183:Postoperative Complications / Q000453:epidemiology; D011788:Quality of Life
keywords: Abnormal uterine bleeding; Fibroid uterus; Heavy menstrual bleeding; Hysterectomy; Thermal balloon ablation; Uterine leiomyoma; Vaginal hysterectomy