Objective To assess and compare the efficacy of NovaSure, a novel 3-D bipol
ar endometrial ablation system, for women with severe menorrhagia secondary
to dysfunctional uterine bleeding (DUB), with and without endometrial prep
aration.
Study design A prospective, double-arm, controlled, observational pilot stu
dy 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 chi
ldbearing, with non-distorted uterine cavities, and cornu-to-cornu measurem
ent 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 treat
ment for endometrial thinning. Pictorial blood assessment chart (PBLAC) dia
ry sampling was used to select patients for the study, as well as to conduc
t the post-treatment evaluation of menstrual blood loss and bleeding patter
n (amenorrhoea, spotting, hypomenorrhea, eumenorrhoea or menorrhagia). All
patients received the treatment under intravenous sedation with paracervica
l block.
Results No intraoperative complications were observed. Treatment time avera
ged 72 seconds. Follow up of 12 months has been completed in 29 patients. N
o 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 su
ccessfully used as an effective method of treatment for women with menorrha
gia secondary to DUB. Endometrial pretreatment appears not to be necessary
in global ablation performed using the NovaSure system.