Two-year results of a new two-minute hot liquid balloon endometrial ablation system (Thermablate): a pilot study

To evaluate the feasibility, safety and clinical outcomes of a new 2-minute hot liquid balloon endometrial ablation system (Thermablate). This prospective observational study included 72 premenopausal women with menorrhagia. All patients were treated from February 2005 through February 2008 under general anaesthesia in the Department of Obstetrics and Gynaecology at the University Hospital of Alexandroupolis, Greece. Thinning of the endometrium was achieved by sharp curettage immediately prior to the procedure. Pretreatment evaluation of menstrual blood flow, duration of menses and frequency of menses were recorded on all patients. Patient records were screened for adverse events, post procedure pain and required medication, dysmenorrhea, satisfaction and menstrual bleeding patterns. Follow-up at three months (n = 72), 6 months (n = 62), 12 months (n = 47) and 24 months (n = 17) showed a trend towards reduced monthly blood flow. Combined amenorrhea and hypomenorrhea rates at 3, 6, 12 and 24 months were 39%, 73%, 77% and 70%, respectively. The corresponding satisfaction rates were 86%, 93.5%, 93.5% and 82.4%, respectively. Dysmenorrhea rates increased from 37.5% prior to surgery, to 57% at three months and decreased to 23.5% at 24 months (p < 0.0001). Endometrial ablation with the Thermablate system is a safe and effective therapy for dysfunctional uterine bleeding when other therapies are contraindicated or have been tried and failed.