UTERINE THERMAL BALLOON THERAPY FOR THE TREATMENT OF MENORRHAGIA - THE FIRST 300 PATIENTS FROM A MULTICENTER STUDY

Objective To evaluate the safety and efficacy of thermal balloon thera py for menorrhagia. Design Prospective, observational study. Setting F ifteen centres in Canada and Europe. Population Two hundred and ninety -six eligible women for whom follow up data were available for three m onths or more. Eligible women included those for whom further fertilit y was not a concern, were not postmenopausal, suffered from intractabl e menorrhagia, had a normal uterine cavity, and who were fully informe d regarding the investigational nature of uterine thermal balloon ther apy. Methods Three hundred and twenty-one procedures of balloon endome trial ablation were performed using the same protocol between June 199 4 and August 1996. Exclusion criteria included structural uterine abno rmality or (pre) malignant lesions. Treatment entailed controlled heat ing of fluid in an intrauterine balloon. General anaesthesia was emplo yed in the 61% of procedures while local anaesthesia with or without s edation was used in 39% of cases. Analysis Follow up data at 3 and/or 6, and/or 12 months were required for inclusion in the analysis. A pai red t test, Wilcoxon signed-ranks test, and multiple and logistic regr ession analyses were used to evaluate the changes in bleeding and dysm enorrhoea patterns, and possible confounding variables, respectively. Success was defined as the subjective reduction of menses to eumenorrh oea or less. Results No intra-operative complications occurred, and po st-operative morbidity was minimal. Success of the procedure was const ant over the year (range 88%-91%). Treatment led to a significant decr ease in the duration of menstrual flow and severity of pain (P < 0.000 1). Increasing age, higher balloon pressure, smaller uterine cavity, a nd a lesser degree of pre-procedure menorrhagia were associated with s ignificantly improved results. Pre-treatment with gonadotrophin releas ing hormone agonists increased amenorrhoea and spotting rates (P = 0.0 3), but was only used in 5% of cases. Conclusion Thermal balloon endom etrial ablation appears to be safe, as well as effective in properly s elected women with menorrhagia and is potentially an outpatient proced ure.