Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia.

STUDY
OBJECTIVE: To collect long-term follow-up information from women who participated in a randomized trial comparing uterine balloon therapy (UBT; Gynecare, Somerville, NJ) with rollerball ablation for treatment of menorrhagia.
DESIGN: Five-year contact of participants treated in a 1996 multicenter, randomized trial (Canadian Task Force classification I).
SETTING: Twelve North American university and private practice centers. PATIENTS: Women treated with endometrial ablation for menorrhagia who were available for 5-year follow-up. INTERVENTION: Uterine balloon therapy or rollerball ablation.
MEASUREMENTS AND MAIN RESULTS: Of 255 women treated under the original protocol, 147 were available to be interviewed 5 years after the procedure. Of these, 25 patients reported hysterectomy, repeat ablation, or dilatation and curettage (D&C) between years 3 and 5, leaving 122 eligible for analysis (61 UBT, 61 rollerball). Of these 122 patients, 58 (95%) having UBT and 59 (97%) having rollerball ablation reported normal or less bleeding. Similarly, 93% and 100%, respectively, were satisfied with the procedure. Among the total population of 255 women, 42 hysterectomies (21 UBT, 21 rollerball), 5 repeat ablations (3 UBT, 2 rollerball), and 1 D&C (rollerball) were reported by year 5. Thirty-five hysterectomies (83%) were performed because of bleeding and/or pelvic pain; one-third of them were associated with myomas. Nearly 7 of 10 women were cured of menorrhagia without additional intervention 5 years after ablation.
CONCLUSION: UBT continues to be an effective, simple treatment of menorrhagia, with clinical outcomes similar to those of rollerball ablation at 5-year follow-up.

RCT Entities:   Population Interventions Outcomes