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.