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


METHODS
Five-year contact of participants treated in a 1996 multicenter, randomized trial (Canadian Task Force classification I).


METHODS
Twelve North American university and private practice centers.


METHODS
Women treated with endometrial ablation for menorrhagia who were available for 5-year follow-up.


METHODS
Uterine balloon therapy or rollerball ablation.


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.


CONCLUSIONS
UBT continues to be an effective, simple treatment of menorrhagia, with clinical outcomes similar to those of rollerball ablation at 5-year follow-up.
Loffer
Franklin D
FD
Department of Obstetrics and Gynecology, University of Arizona, 3410 North 4th Avenue, Phoenix, AZ 85013.
Grainger
David
D
D000328:Adult; D021721:Balloon Occlusion / Q000295:instrumentation / Q000379:methods*; D017115:Catheter Ablation / Q000295:instrumentation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015907:Hysteroscopy / Q000379:methods*; D007431:Intraoperative Complications; D008595:Menorrhagia / Q000175:diagnosis / Q000601:surgery* / Q000628:therapy; D008597:Menstrual Cycle / Q000502:physiology; D008875:Middle Aged; D017060:Patient Satisfaction; D011183:Postoperative Complications; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome