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)