Thermal endometrial destruction by means of a balloon catheter : experimental and clinical evaluation of a new form of treatment for menorrhagia

Abstract: Thermal endometrial destruction by means of a silicone balloon catheter is a new form of treatment for menorrhagia aimed at reducing menstrual blood loss. The purpose of the present work was to study, experimentally, the thermal effects on and the thermal conductivity of uterine tissue, to obtain a basis for the estimation of optimal treatment conditions by means of numerical analyses using a computer simulation model, to elucidate possible problems which may arise during the procedure, to evaluate how the patients tolerated this treatment and to judge which patients were suitable for this form of treatment and, finally, to study the uterine cavity after treatment and the long-term results of treatment. The treatment was performed on 117 women from August 1993 to December 1996, and 116 were followed up. The treatment exerts thermal effects on the endometrium and myometrium without damage to surrounding tissue. The endometrium and myometrium were found to have similar thermal conductivities. Simulations demonstrated the importance of the intracavitary temperature and pressure, while the duration of the treatment was found to be less important. There were no immediate peroperative complications, and the treatment was well tolerated by the patients. Women exhibiting uterine intracavitary changes should not be treated by this form of treatment and it should not be recommended for women with submucosal leiomyomas. After treatment, the uterine cavity was observed to be fibrotic. The treatment significantly reduced the measured menstrual blood volume (p<0.001) and the number of reported bleeding days (p<0.001). After 25 months' mean follow-up time (range 10-49) the success rate was 94%, excluding women with preoperative intracavitary changes and pretreatment ultrasonographically identified submucosal leiomyomas. Thus, this out-patient treatment has a high success rate. It is safe for the patient and easy for the physician to learn.