Because menorrhagia is the underlying reason for more than one third of the hysterectomies performed annually in the United States, the development of alternative treatments is very important. Hysteroscopic rollerball endometrial ablation has been shown to have a clinical efficacy comparable to that of hysterectomy, but the technique requires considerable training and is most successful when combined with weeks of preoperative therapy to reduce the thickness of the endometrial lining. Roller-ball ablation also carries a small but finite risk of hemorrhage, uterine perforation and complications of anesthesia. The thermal uterine balloon system is believed to provide comparable efficacy with less need for preoperative treatment, general anesthesia or extensive operator training. Meyer and colleagues compared the rollerball ablation technique with the thermal balloon technique.
Fourteen investigative centers in North America enrolled 275 women who had menorrhagia resistant to medical therapy and were considered good candidates for endometrial ablation. The patients were between 29 and 51 years of age (mean age: 40 years) and reported, on average, a 10-year history of menorrhagia. All of the study participants had received normal results on Papanicolaou smears and endometrial biopsies within the previous six months. Each woman's uterine cavity was anatomically normal. The presence of menorrhagia was documented, and patients provided subjective information about their symptoms and the effect the symptoms had on their normal daily activities. The patients were randomly assigned to treatment with either thermal balloon or rollerball ablation. No endometrial pretreatments were used. Types of anesthesia and analgesia were not controlled in the study. Patients were discharged the same day the procedure was performed and contacted by telephone within 24 hours. At one week and at three, six and 12 months following ablation, patients were examined, and symptoms and menstrual charts assessed.
The procedures were performed on 255 women. After 12 months, complete evaluation data were available for 239 participants. The two groups were comparable before the study in all important variables, including symptoms and hemoglobin levels. General anesthesia was given to 84 percent of those treated with rollerball ablation, compared with 53 percent of those undergoing thermal balloon ablation. The procedure was completed in less than 30 minutes in 71 percent of patients treated with thermal balloon ablation, but the same was true for only 28.6 percent of those in the rollerball treatment group. No complications were noted in those treated with the thermal balloon technique, but one case of uterine perforation, two cases of fluid overload and one case of cervical lacerations occurred in patients treated with rollerball ablation. Postoperative complications, mostly local infections, occurred in four patients in the thermal balloon treatment group and three in the rollerball treatment group. Over 80 percent of patients in both groups reported a return to normal bleeding or less bleeding 12 months after the procedure. The number of women with anemia was reduced in both groups by over 60 percent. Over 85 percent of all patients indicated that they were “highly satisfied” with the results of the procedure.
The authors conclude that uterine thermal balloon endometrial ablation is as efficacious as rollerball ablation and may have advantages in safety and related factors. Both procedures provide effective treatment for menorrhagia in selected patients.