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-I) 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. (C) 2004 Elsevier Inc. All rights reserved.