A double-blind randomized trial comparing the Cavaterm™ and the NovaSure™ endometrial ablation systems for the treatment of dysfunctional uterine bleeding

Objective: To compare two second-generation endometrial ablation systems in women with dysfunctional uterine bleeding (DUB) who want conservative surgical treatment. Design: A double-blind, randomized trial. Setting: A minimal access gynecological surgery unit in northeast England. Patient(s): Fifty-seven women diagnosed with DUB were recruited, with 55 undergoing surgery and completing 12-month follow-up. Intervention(s): Thirty-seven women underwent a NovaSure(TM) endometrial ablation, and 18 had a Cavaterm(TM) endometrial ablation. Clinical and quality of life data were collected 6 and 12 months after treatment. Main Outcome Measure(s): Amenorrhea, menstrual change, quality of life, sexual activity, patient satisfaction, and procedure acceptability. Result(s): Amenorrhea, hypomenorrhea, eumenorrhea, and menorrhagia rates for the Cavaterm(TM) and Novasure(TM) groups at 12 months were 2/18 (11%) vs. 16/37 (43%); 11/18 (61%) vs. 10/37 (27%); 5/18 (27%) vs. 6/37 (16%); and 0/18 vs. 5/37 (13%), respectively. At 12 months, 83% and 92% of women were either satisfied or very satisfied in the Cavaterm(TM) or Novasure(TM) groups, respectively. There were no major complications in either group. Conclusion(s): Both the Cavaterm(TM) and the Novasure(TM) endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure(TM) system achieved a statistically significantly higher rate of amenorrhea in this study. (C)2003 by American Society for Reproductive Medicine.