Preliminary outcomes of longer freeze cycles in the treatment of women with abnormal uterine bleeding using cryogen first option uterine cryoblation therapy

Objective: This was a single-center study to evaluate the effectiveness of treating women with abnormal uterine bleeding (AUB) using the First Option Uterine Cryoblation Therapy and using up to four freeze cycles. Methods: A single-center study is underway to evaluate uterine cryoblation under ultrasonographic guidance in women with AUB. The protocol was modified from the U.S. multicenter study to allow up to four freeze cycles. In addition, half of the patients received pretreatment endometrial thinning with leuprolide acetate and half received no pretreatment. All patients are premenopausal, 30–50 years of age with documented menorrhagia and a diary score more than 150. They have failed medical therapy and have been shown to be free of endometrial pathology on ultrasonography, biopsy, hysteroscopy, or a combination. Treatment of women with fibroids was left to the physician’s medical judgment. Results: Thirty-four patients have been treated to date. The first 13 patients were treated in the operating room. The other 21 patients have been treated in a procedure room, with 82% receiving a paracervical block/conscious sedation and 18% receiving only paracervical block. A total of 19 patients received 3 freeze cycles, and 8 received 4 freeze cycles. Of the group that received leuprolide acetate, all are considered successes by PBAC ≤ 75 at 6 months. In the non–leuprolide acetate group, only five of eight are successes by PBAC. No major complications have been reported, and all patients have tolerated the procedure well. Conclusions: Preliminary experience suggests that additional freeze cycles can contribute to higher outcomes and that some type of pretreatment is important to achieve optimal outcomes.