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.
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.
Authors: Jeffrey D Miller; Gregory M Lenhart; Machaon M Bonafede; Cindy M Basinski; Andrea S Lukes; Kathleen A Troeger Journal: Int J Womens Health Date: 2015-01-06
Authors: Jeffrey D Miller; Gregory M Lenhart; Machaon M Bonafede; Andrea S Lukes; Shannon K Laughlin-Tommaso Journal: Popul Health Manag Date: 2015-02-25 Impact factor: 2.459