Treatment of Non-Atypic Endometrial Hyperplasia Using Thermal Balloon Endometrial Ablation Therapy

Abstract

In this study, women with nonatypic endometrial hyperplasia were treated with thermal balloon ablation therapy to investigate the effects of this technique. The heat from thermal balloon ablation causes coagulation and necrosis of the endometrium and superficial myometrium. Thirty-four perimenopausal women (mean age, 48 years; range, 37-64 years) with simple or complex endometrial hyperplasia were enrolled in a randomized trial to compare thermal balloon ablation therapy (n = 17) with traditional progestin therapy (n = 17). Study patients were randomized according to menopausal status. The oral progestin administration regimen for premenopausal women consisted of 3 consecutive months of sequential medroxyprogesterone acetate given at 10 mg per day for 10 days starting on day 15 of their menstrual cycle. Postmenopausal women received 10 mg per day continuous medroxyprogesterone acetate for 3 months. Thermal ablation balloon therapy was performed from day 3 to day 8, in premenopausal women, and on the day of randomization in postmenopausal patients. At 6 months and 12 months after treatment, all study patients returned for clinical evaluation, which included physical examination, transvaginal ultrasonography, and endometrial biopsy. Women with abnormal ultrasound but negative endometrial biopsy underwent dilation and curettage or hysterectomy. Eighteen months after the end of the study period, patient records were reviewed and any further medical interventions were recorded. At the 6-month follow-up examinations, 3 women in the thermal balloon ablation group were found to have simple hyperplasia and were treated by hysterectomy. None had hyperplasia on final histopathologic review of the uterine specimen. In the progestin-treated group, a single postmenopausal woman was diagnosed with complex, atypical hyperplasia. She was diagnosed with stage IIIA, grade 1 endometrial adenocarcinoma and was treated with surgery followed by chemotherapy. At the 12-month follow up, one additional woman in the thermal ablation and 5 women in the progestin arm of the study were found to have simple hyperplasia by endometrial biopsy. These women all had hysterectomy with no abnormal endometrial findings on final pathology review. In addition to the 10 women who underwent hysterectomy for hyperplasia, by 18 months after the initial treatment, one patient in the ablation therapy group and 2 in the progestin group had undergone hysterectomy for irregular bleeding and pain. All had normal endometrial histology.