Study objective: To determine the effectiveness of endometrial cryoablation in comparison with rollerball electroablation.
Design: Prospective, randomized study (Canadian Task Force classification I).
Setting: Ten university and private medical centers in the United States.
Patients: Two hundred seventy-nine women with menorrhagia due to benign causes.
Intervention: Endometrial ablation using a Her Option cryoablation device in 193 women and rollerball electroablation in 86.
Measurements and main results: Women treated by cryoablation received significantly less general anesthesia (46%) than those treated by electroablation (92%). Subjects maintained menstrual diaries for at least one cycle before and for 12 months after the procedure. Success was defined as reduction of menstrual bleeding to a score of 75 or less in the absence of retreatment. Success rates in the cryoablation and electroablation groups were 77.3% and 83.8%, respectively. Bleeding declined by 92% and 94%, respectively. Both procedures led to significant improvements in a broad range of symptoms including menses-related pain, mood, and overall improvement in quality of life.
Conclusions: Endometrial cryoablation is a safe and effective procedure in treatment of dysfunctional uterine bleeding. Its advantages include technical ease of performance, direct ultrasonographic view of depth of ablation, little anesthetic, and avoidance of potential complications related to distention media.