NovaSure impedance-controlled system for endometrial ablation.
OBJECTIVE
To assess the efficacy and safety of the NovaSure endometrial ablation system in women with severe dysfunctional uterine bleeding (DUB).


METHODS
Prospective, single-arm, controlled, observational pilot study (Canadian Task Force classification II-1).


METHODS
Free-standing center for gynecologic endoscopy.


METHODS
One hundred seven premenopausal women whose menorrhagia was unresponsive to medical therapy, who had completed childbearing, and who had undistorted uterine cavities.


METHODS
Endometrial ablation with the NovaSure system.


RESULTS
Diaries were used to qualify patients for the study, as well as for posttreatment evaluation of menstrual blood loss and bleeding pattern (amenorrhea, spotting, hypomenorrhea, eumenorrhea, menorrhagia). No drug or mechanical endometrial pretreatment was administered. Position of the uterus was not a factor in patient selection. No intraoperative or postoperative complications occurred. Treatment time averaged 94 seconds. Of 107 women, 106 completed 6 months of follow-up and 105 had 12 months. Amenorrhea was 46% and 58%, respectively.


CONCLUSIONS
The NovaSure System is safe and is effective in treating women with DUB. Endometrial pretreatment is not necessary, and presence of blood in the uterine cavity during treatment is not a limiting factor.
Gallinat
Adolf
A
Tagesklinik Altonaer Strasse, Altonaer Strasse 59-61, Hamburg 20357, Germany.
Nugent
Wolfgang
W
D000328:Adult; D017115:Catheter Ablation / Q000295:instrumentation*; D004717:Endometrium / Q000601:surgery*; D005260:Female; D006801:Humans; D008595:Menorrhagia / Q000601:surgery*; D008875:Middle Aged; D011446:Prospective Studies