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

Study Objective. To evaluate 2-year follow-up results in patients participa ting 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 en dometrial ablation. Measurements and Main Results. Patient satisfaction with both treatments wa s consistently high. Only 15 hysterectomies had been performed (6 for menor rhagia) 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 i n avoiding hysterectomy and relieving symptoms of menorrhagia. Additional b enefits were reduction in dysmenorrhea and premenstrual syndrome.