Is endometrial pretreatment necessary in NovaSure™ 3-D endometrial ablation?

Abstract

Objective

To assess and compare the efficacy of NovaSure, a novel 3-D bipolar endometrial ablation system, for women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB), with and without endometrial preparation.

Study design

A prospective, double-arm, controlled, observational pilot study of 40 women undergoing endometrial ablation using the NovaSure system.

Patients

40 premenopausal women, of average age 44 years, with menorrhagia secondary to DUB and unresponsive to medical therapy, who had completed childbearing, with non-distorted uterine cavities, and cornu-to-cornu measurement of greater than 2.5 cm.

Interventions

Endometrial ablation using the 3-D bipolar NovaSure system.

Methods

50% of the patients received gonadotrophin-releasing hormone (GnRH) agonist for endometrial thinning. The remaining patients received no treatment for endometrial thinning. Pictorial blood assessment chart (PBLAC) diary sampling was used to select patients for the study, as well as to conduct the post-treatment evaluation of menstrual blood loss and bleeding pattern (amenorrhoea, spotting, hypomenorrhea, eumenorrhoea or menorrhagia). All patients received the treatment under intravenous sedation with paracervical block.

Results

No intraoperative complications were observed. Treatment time averaged 72 seconds. Follow up of 12 months has been completed in 29 patients. No significant difference was observed in the outcome (i.e. efficacy) of the procedure between the two groups of patients.

Conclusions

Preliminary results indicate that the NovaSure system can be successfully used as an effective method of treatment for women with menorrhagia secondary to DUB. Endometrial pretreatment appears not to be necessary in global ablation performed using the NovaSure system.