Microwave endometrial ablation trials promising. (Patients with Submucosal Fibroids).

SAN FRANCISCO -- Microwave endometrial ablation stacked up well against rollerball ablation for the treatment of abnormal uterine bleeding in preliminary data from an ongoing randomized, multicenter trial, Dr. Carl R. Della Badia reported.

Of the 86 women who have been followed for 12 months after the procedure, 70% of 57 women who had microwave ablation were amenorrheic, compared with 38% of 29 women who had roller-ball ablation, he said at the annual meeting of the American Association of Gynecologic Laparoscopists.

The study was funded by the device's manufacturer, Microsulis Corp. of Fort Lauderdale, Fla., which expects to apply for Food and Drug Administration approval of the device this fall, a company spokeswoman told this newspaper. Devices used to perform microwave ablation are already available in Canada and Europe.

In the study, 317 premenopausal women with menorrhagia were randomized to receive microwave endometrial ablation or rollerball ablation in a 2:1 ratio. All patients were aged 30 years or older and had failed, refused, or were unable to tolerate medical therapy Uterine cavities measured 6-14 cm with no endometrial pathology on biopsy. All were pretreated with leuprolide several weeks before ablation.

Follow-up data were available for 259 patients 3 months after ablation. Among the 169 patients randomized to microwave ablation, 40% were amenorrheic, compared with 38% of 90 patients randomized to rollerball ablation.

The study included women with submucosal myomas no larger than 3 cm in diameter. Patients with fibroids who were randomized to rollerball ablation also underwent electrocautery loop resection of the fibroid, but the electrocautery was not used to remove the endometrium in general. Fibroids were not resected in patients undergoing microwave ...