Thermal balloon and rollerball ablation to treat menorrhagia: two-year results of a multicenter, prospective, randomized, clinical trial

Abstract

Study objective: To evaluate 2-year follow-up results in patients participating in a randomized, clinical trial comparing uterine balloon therapy with rollerball endometrial ablation.

Study design: Prospective, randomized, clinical trial (Canadian Task Force classification I).

Setting: Fourteen university-affiliated and private practice sites.

Patients: Two hundred fifty-five women with menorrhagia.

Interventions: Patients were randomized to rollerball or uterine balloon endometrial ablation.

Measurements and main results: Patient satisfaction with both treatments was consistently high. Only 15 hysterectomies had been performed (6 for menorrhagia) at the end of 2 years, 11 in the rollerball group, 4 in the balloon therapy group.

Conclusion: Endometrial ablation by both procedures was highly successful in avoiding hysterectomy and relieving symptoms of menorrhagia. Additional benefits were reduction in dysmenorrhea and premenstrual syndrome.