Preliminary data from multi-center study using cryogen first option uterine cryoblation therapy in women with abnormal uterine bleeding

Abstract

Objective: To evaluate the safety and effectiveness of the First Option Uterine Cryoblation Therapy in women with abnormal uterine bleeding (AUB).Methods: A multicenter study is underway to evaluate uterine cryoblation under ultrasound guidance for women with AUB, compared with electrosurgical ablation. All patients are pre-menopausal, are menorrhagic with a diary score greater than 150, have failed medical therapy, have a uterine volume of 300 or less with a uterine sound of 10 or less, and are free of endometrial pathology on ultrasonography, biopsy, and hysteroscopy. Intramural fibroids did not exclude patients from participation unless they were greater than 2 cm in diameter.Results: Data on 87 patients at 6 months shows an amenorrhea/staining outcome of 54%. Overall success as measured by diary score of 75 or less is 90%. Sixty-three percent of the electrosurgery patients were given general anesthesia, compared with 29% of the cryoblation patients. Thirty-five percent of the cryoblation patients received as paracervical block and conscious sedation, compared with only 1% of the electrosurgery group. The procedure has been done successfully in the operating room, procedure room, or office with no major complications to date.Conclusions: Preliminary data indicates that uterine cryoblation is a safe and effective treatment for AUB.