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. Conclusion TBA can replace vaginal hysterectomy in some perimenopausal women with uterine leiomyomas. Clinical Trials Registry India: CTRI/2016/07/007119.