G A Vilos1, E C Vilos, L Pendley. 1. Department of Obstetrics and Gynecology, St. Joseph's Health Centre, 268 Grosvenor Street, London, Ontario, Canada N6A 4V2.
Abstract
STUDY OBJECTIVE: To evaluate the safety and clinical efficacy of a uterine thermal balloon endometrial ablation system for the treatment of menorrhagia. DESIGN: Prospective pilot study. SETTING: University-affiliated teaching hospital. PATIENTS: Thirty women with menorrhagia who met inclusion and exclusion criteria and signed informed consent. INTERVENTIONS: Under general (9 women) or neuroleptic (21) anesthesia and paracervical block, a 16-cm long, 3-mm diameter catheter with a latex balloon at its tip, housing a heating element, was inserted blindly transcervically into the uterus and filled with sterile 5% dextrose in water solution (range 2-21 ml, mean 9.2 ml). The catheter was connected to a control unit that maintained the temperature at 87 degrees C, monitored the pressure, and terminated the treatment after 8 minutes. MEASUREMENTS AND MAIN RESULTS: There were no intraoperative or postoperative complications. At 6 months 25 patients (83%) reported significant improvement in menorrhagia (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 7). By 12 months 23 women (77%) reported significant improvement (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 5). CONCLUSIONS: Uterine balloon thermal therapy is a safe and effective option for women with menorrhagia. The procedure does not require additional training and expertise in operative hysteroscopy and the presently used energy sources. It requires no cervical dilatation (5 mm), is tolerated well under neuroleptic anesthesia, and potentially can be offered as an office procedure under local anesthesia.
STUDY OBJECTIVE: To evaluate the safety and clinical efficacy of a uterine thermal balloon endometrial ablation system for the treatment of menorrhagia. DESIGN: Prospective pilot study. SETTING: University-affiliated teaching hospital. PATIENTS: Thirty women with menorrhagia who met inclusion and exclusion criteria and signed informed consent. INTERVENTIONS: Under general (9 women) or neuroleptic (21) anesthesia and paracervical block, a 16-cm long, 3-mm diameter catheter with a latex balloon at its tip, housing a heating element, was inserted blindly transcervically into the uterus and filled with sterile 5% dextrose in water solution (range 2-21 ml, mean 9.2 ml). The catheter was connected to a control unit that maintained the temperature at 87 degrees C, monitored the pressure, and terminated the treatment after 8 minutes. MEASUREMENTS AND MAIN RESULTS: There were no intraoperative or postoperative complications. At 6 months 25 patients (83%) reported significant improvement in menorrhagia (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 7). By 12 months 23 women (77%) reported significant improvement (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 5). CONCLUSIONS: Uterine balloon thermal therapy is a safe and effective option for women with menorrhagia. The procedure does not require additional training and expertise in operative hysteroscopy and the presently used energy sources. It requires no cervical dilatation (5 mm), is tolerated well under neuroleptic anesthesia, and potentially can be offered as an office procedure under local anesthesia.