From June 1994 to December 1995, 116 women (mean age 39 yrs, range 27-50 yrs) who met inclusion and exclusion criteria underwent endometrial ablation with a thermal balloon system. Forty-one (35%) were treated under general and 71 (61%) under neuroleptic anesthesia. Four (3%) treatments were performed under paracervical block only. A 16-cm long, 3-mm diameter catheter with a latex balloon at its tip housing a heating element was inserted into the uterus and filled with sterile 5% dextrose in water solution (mean 10.4 ml, range 2-55 ml). The catheter was connected to a control unit that maintained the temperature at 87 ± 5° C, monitored the pressure, and terminated the treatment after 8 minutes. The starting uterine pressure was 80 to 140 mm Hg in the first 13 women and greater than 140 mm Hg in the rest. Nineteen women were treated for 12 minutes and all others for 8 minutes. Complications were endometritis (3), hematometra (2), and cystitis (1). At 6-month follow-up, after 8 minutes of treatment, persistent menorrhagia was reported by 38% and 12% of patients at less than and greater than 140 mm Hg pressure, respectively. At greater than 140 mm Hg pressure, menorrhagia was reported by 13% of women after 8 and 12 minutes of treatment. In 38 women, amenorrhea or spotting occurred in 29%, hypomenorrhea in 45%, eumenorrhea in 21%, and menorrhagia in 5%. Uterine balloon therapy is a safe and effective treatment for menorrhagia at uterine pressures of 150 to 180 mm Hg and of 8 minutes' duration.
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