Three-year comparison of thermal balloon and rollerball ablation in treatment of menorrhagia.
STUDY OBJECTIVE: To compare uterine balloon therapy and hysteroscopic rollerball endometrial ablation with respect to efficacy and safety in treatment of menorrhagia. DESIGN: Multicenter, prospective, randomized study (Canadian Task Force classification I). SETTING: Fourteen North American university and private practice sites. PATIENTS: Women undergoing endometrial ablation for menorrhagia. INTERVENTION: Rollerball endometrial ablation or uterine balloon therapy. MEASUREMENTS AND MAIN RESULTS: Of 275 women randomized to one of these procedures, 255 were treated under the protocol and 214 were followed for 3 years. Results of uterine balloon therapy and rollerball endometrial ablation remained similar, with little difference at 3 years compared with results at 1 year. We noted a suggestion of an increase in hysterectomies in the rollerball group (14) compared with the uterine balloon therapy group (8) at 3 years. CONCLUSION: Endometrial ablation with the ThermaChoice uterine balloon or rollerball continues at 3 years to be a successful method for treating menorrhagia, avoiding hysterectomy, decreasing dysmenorrhea and premenstrual symptoms, and improving quality of life. (J Am Assoc Gynecol Laparosc 8(1):48-54, 2001)