An impedance-controlled system for endometrial ablation: five-year follow-up of 107 patients.

OBJECTIVE: To assess the safety, efficacy and data durability of the NovaSure endometrial ablation system 5 years after the procedure in women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB). STUDY DESIGN: A prospective, single-arm, pilot study of 107 women undergoing endometrial ablation using the NovaSure system (Canadian Task Force classification II-1) at a specialized center for gynecologic endoscopy. The premenopausal women, with menorrhagia secondary to DUB unresponsive to medical therapy, had completed childbearing. A Pictorial Blood-Loss Assessment Chart was used to conduct a posttreatment evaluation of menstrual blood loss and bleeding pattern. Ablation was performed without any type of endometrial pretreatment. RESULTS: No intraoperative or postoperative complications were observed. Treatment time averaged 94 seconds. At the 5-year follow-up, amenorrhea was reported by 75% of patients and successful reduction of bleeding was achieved in 98%, with hysterectomy and retreatment rates of 2.9% and 3.8%, respectively. CONCLUSION: Long-term clinical results indicate that the NovaSure system is a safe and effective method for treatment of women with menorrhagia secondary to DUB. NovaSure yields high amenorrhea and success rates and low surgical reintervention rates 5 years after treatment.

NovaSure impedance controlled system for endometrial ablation: three-year follow-up on 107 patients.

OBJECTIVE: This study was undertaken to assess the safety, efficacy, and data durability of the NovaSure ablation at 3 years after the procedure in women with menorrhagia secondary to dysfunctional uterine bleeding (DUB). STUDY DESIGN: A prospective, single-arm, observational pilot study (Canadian Task Force classification II-1) was carried out at a specialized center for gynecologic endoscopy with 107 premenopausal women with menorrhagia secondary to DUB. NovaSure ablation was performed in 107 patients. Pictorial Blood loss Assessment Chart diary sampling was used to assess menstrual blood loss. Ablation was performed without any type of endometrial pretreatment. RESULTS: No intraoperative or postoperative complications were observed. Treatment time averaged 94 seconds; 65% of the patients reported amenorrhea. Hysterectomy was avoided in 97.2% of patients at 3-year follow-up. CONCLUSION: Long-term clinical results demonstrate that the NovaSure system is a safe and effective method for treatment of women with menorrhagia secondary to DUB, yielding high amenorrhea and success rates, with low re-treatment rates.

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 107 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.