Clinical Question: Is radio-frequency endometrial ablation more effective than balloon ablation for the treatment of menorrhagia?
Setting: Inpatient (any location) with outpatient follow-up
Study Design: Randomized controlled trial (double-blinded)
Synopsis: In this trial, women with menorrhagia and no intracavitary abnormalities were assigned randomly (1:2) to the newer bipolar radio-frequency endometrial ablation technique (n = 83) or hot-water balloon ablation therapy (n = 43). The same surgeon treated all of the women. The women and physician investigators who assessed outcomes were blinded to treatment group assignment.
Women in the radio-frequency group were more likely to have amenorrhea at three, six, nine, and 12 months after the procedure. At 12 months, amenorrhea occurred in 43 percent of the women in the radio-frequency group and 8 percent of those in the balloon-therapy group (P < .001; number needed to treat [NNT] = three; 95 percent confidence interval, two to five). Patient satisfaction at 12-month follow-up was 90 percent in the radio-frequency group and 79 percent with balloon therapy (P = .003; NNT = 11). The mean duration of the surgical intervention was nine minutes in the radio-frequency group and 14 minutes in the balloon-therapy group.
The study was too small to determine whether the lower rate of dysmenorrhea in the radio-frequency group was statistically significant, although it would be clinically significant if found to be true (8 percent versus 16 percent). The study also was too small and too short to detect a difference in hysterectomy rates.
Bottom Line: Amenorrhea is achieved more often with radio-frequency endometrial ablation than with hot-water balloon ablation. Women tend to be more satisfied with the radio-frequency technique one year after therapy. A reassessment of the treated women after a longer follow-up period is needed. (Level of Evidence: 1b–)