Microwave Endometrial Ablation vs. Rollerball Electroablation for Menorrhagia: A Multicenter Randomized Trial

Abstract

Study Objective

To compare the effectiveness, safety, and acceptability of microwave endometrial ablation (MEA) with those of rollerball electroablation (REA) for the treatment of menorrhagia.

Design

Randomized clinical trial (Canadian Task Force classification I).

Setting

Eight academic medical centers and private medical practices.

Patients

Three hundred twenty-two women with documented menorrhagia due to benign causes.

Intervention

MEA or REA.

Measurements and Main Results

By intent-to-treat analysis, the success rate of MEA at 12 months (87.0%; CI 81.7%–91.2%) did not differ significantly (p = .40) from that of REA (83.2%; CI 74.7%–89.7%). Among evaluable patients, success rate was also similar (p = .24) in the MEA (96.4%; CI 92.7%–98.5%) and REA (92.7%; CI 85.6%–97%) groups. The amenorrhea rate in evaluable patients after MEA was 61.3% (CI 54.1%–68.2%). In patients with myomas, the success and amenorrhea rates in evaluable patients after MEA were 90.3% (CI 74.2%–98%) and 61.3% (CI 42.2%–78.2%), respectively. In evaluable patients with body mass index of 30 kg/m² or greater, MEA success rate was 96.7% (CI 88.5%–99.6%) compared with 81.8% (CI 59.7%–94.8%) for REA (p = .042). The ablation procedure was performed under IV sedation in 62% of patients in the MEA group versus 18% of patients in the REA group (p <.001); whereas, general anesthesia was employed more often in patients undergoing REA (37% vs. 76%, p <.001). No major complications were encountered. Patient satisfaction with results of treatment was high (98.5% of the MEA and 99.0% of the REA group).

Conclusion

Microwave endometrial ablation is an efficacious and safe procedure for the treatment of menorrhagia. Over half of patients treated with MEA achieve amenorrhea, and the procedure is suitable for women with myomas and irregular uterine cavities. The procedure is easily learned and can be performed rapidly, under IV sedation in most cases.