Abstract: Endometrial ablation with NovaSure GEA, a pilot study.

Authors:

Busund B, Erno LE, Gronmark A, Istre O

Institution:

Department of Gynecology, Ullevaal University Hospital, 0407 Oslo, Norway.

Source:

Acta Obstet Gynecol Scand. 2003 Jan;82(1):65-8.

Abstract:

OBJECTIVE: A prospective, single-arm, multicenter, controlled, observational pilot study to assess the safety and efficacy of the NovaSure Global Endometrial Ablation (NovaSure GEA) system in women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB). SETTING: University tertiary referring center and central hospital. PATIENTS: Forty-six premenopausal women aged 41.3 years with menorrhagia secondary to DUB unresponsive to medical therapy, who had completed childbearing, with non-distorted uterine cavities were included in the study. METHODS: Bleeding score was recorded before, 6 and 12 months after treatment. All patients received the treatment under intravenous sedation with para-cervical block and were treated with Nova Sure endometrial ablation for mean 94 s at the day surgery unit. RESULTS: No serious intraoperative complications were observed. Treatment time averaged 94 s. Forty-six patients have completed 6-months of follow-up and 45 patients completed the 12-months follow-up. 50% of the patients were amenorrheic at 6 months follow-up and 58% had complete cessation of uterine bleeding (amenorrhea) at 12 months follow-up. CONCLUSIONS: Preliminary results indicates that the NovaSure GEA System is an effective treatment for DUB, achieving 58% amenorrhea after 12 months.

Keywords:

Surgery Gynaecology Endometrial Ablation