NEW YORK (Reuters Health) – Office-based endometrial ablation for menorrhagia is equally effective with thermal balloon ablation or bipolar radiofrequency, U.K. researchers say.

Six months after randomization and treatment, women in the study had no significant differences in amenorrhea rates, the primary end point, and both treatments improved health-related quality of life. But the bipolar procedure took significantly less time and achieved a greater degree of endometrial destruction than the thermal balloon procedure, the researchers said.

The single-center randomized trial, reported online today in Obstetrics & Gynecology, compared the Thermachoice III (Gynecare) thermal balloon ablation device and the NovaSure (Hologic) bipolar radiofrequency device.

These are two of the most commonly used second-generation ablative technologies, said lead author Dr. T. Justin Clark and colleagues from the Birmingham Women’s Hospital and the University of Birmingham.

Both procedures have proven equally effective in terms of patient satisfaction and quality of life — when done on inpatients under general anesthesia. Dr. Clark’s team tested the feasibility and acceptability of the procedures on outpatients under local anesthesia.

Their study involved 81 women with heavy menstrual bleeding (without organic pathology) that was refractory to medical therapy. Thirty-nine were assigned to thermal balloon ablation and 42 to radiofrequency impedance-controlled endometrial ablation.

Overall, both procedures showed “high levels of improvement in heavy bleeding and dysmenorrhea, with no obvious differences between treatments,” the authors report.

Rates of amenorrhea were higher with radiofrequency ablation at all time points after surgery, compared with thermal balloon ablation, but these differences only reached statistical significance at 12 months (56% vs 23%; P = 0.02).

Postprocedure hysteroscopy showed complete endometrial destruction in 88% of women in the radiofrequency group versus 58% of women in the thermal balloon group (P = 0.002).

There were no serious complications with the two procedures.

Among the other findings, dilatation of the cervix was required in all of the women who had radiofrequency ablation, compared with only 2 women (5%) who had the thermal balloon procedure. The bipolar radiofrequency procedure went faster (by 6.2 min; P < 0.001) than the thermal ablation procedure (average total time, 12.4 vs 18.6 minutes). All bipolar procedures were successfully completed, whereas two balloon procedures were not completed due to patient discomfort. Nonetheless, the researchers say they could not find any “no conclusive differences in pain or acceptability” between the two procedures. With hindsight, 41% of women in the balloon group and 34% in the radiofrequency group would have preferred general anesthesia, the authors report, “indicating that further work is needed to improve pain control and the overall patient experience.” Given that both procedures seem to have similar levels of pain associated with them, the authors say the brevity of the bipolar radiofrequency technique is an advantage. Dr. Clark is a member of the European Advisory Board for Hologic, which manufactures the NovaSure bipolar radiofrequency ablation device and has received travel expenses, honoraria for lectures and surgical training from Cytyc (now Hologic). Dr. Clark and a co-author have also received money from Gynecare (now Ethicon Women’s Health & Urology). Reference:
Defining Risk in Women With Polycystic Ovary Syndrome: A Need for Constant Vigilance

Obstet Gynecol 2001;117:109-118.