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

Abstract

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 ™ endometrial ablation, and 18 had a Cavaterm ™ 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 ™ and Novasure ™ 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 ™ or Novasure ™ groups, respectively. There were no major complications in either group. Conclusion(s) Both the Cavaterm ™ and the Novasure ™ endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure ™ system achieved a statistically significantly higher rate of amenorrhea in this study.