NovaSure impedance-controlled system for endometrial ablation

Study Objective. To assess the efficacy and safety of the NovaSure endometrial ablation system in women with severe dysfunctional uterine bleeding (DUB). Study Design. Prospective, single-arm, controlled, observational pilot study (Canadian Task Force classification II-1). Setting. Free-standing center for gynecologic endoscopy. Patients. One hundred seven premenopausal women whose menorrhagia was unresponsive to medical therapy, who had completed childbearing, and who had undistorted uterine cavities. Intervention. Endometrial ablation with the NovaSure system. Measurements and Main Results. Diaries were used to qualify patients for the study, as well as for posttreatment evaluation of menstrual blood loss and bleeding pattern (amenorrhea, spotting, hypomenorrhea, eumenorrhea, menorrhagia). No drug or mechanical endometrial pretreatment was administered. Position of the uterus was not a factor in patient selection. No intraoperative or postoperative complications occurred. Treatment time averaged 94 seconds. Of 707 women, 106 completed 6 months of follow-up and 105 had 12 months. Amenorrhea was 46% and 58%, respectively. Conclusion. The NovaSure System is safe and is effective in treating women with DUB. Endometrial pretreatment is not necessary, and presence of blood in the uterine cavity during treatment is not a limiting factor.