A Randomized Trial Comparing the Levonorgestrel Intrauterine System and Thermal Balloon Ablation for Heavy Menstrual Bleeding

Abstract

Because hysteroscopic endometrial resection and ablation for menorrhagia require a high level of skill to perform effectively and safely, a variety of global ablation devices have been designed for use by those having limited experience with hysteroscopy. They include ablation using a thermal balloon, microwaves, or diffused laser energy; cryoablation; and instillation of hot saline. The present investigators carried out a prospective, randomized trial comparing thermal balloon ablation with the levonorgestrel intrauterine system (LNG-IUS), an intrauterine device that releases 20 μg levonorgestrel every 24 hours over 5 years. Forty women 25 to 50 years of age with self-described heavy menstrual bleeding were assigned to the LNG-IUS and 39 others to thermal balloon ablation. Menstrual blood loss was estimated using a pictorial bleeding assessment chart after 3, 6, 9, 12, and 24 months. Menstrual blood loss was significantly reduced in both treatment groups, but at 12 and 24 months, bleeding scores were significantly lower in women treated with the LNG-IUS. There was a similar trend in rates of amenorrhea, which, however, was significant only at 24 months. Days of heavy bleeding were significantly reduced in both groups at 3 months. Fewer women had disturbed sleep and more felt able to leave home. More than 80% of women in both groups felt that their treatment had succeeded, and similar numbers of women in the 2 treatment groups would recommend their treatment to a friend. No serious complications were encountered. Self-rated quality of life increased significantly for women in both groups at 3, 12, and 24 months. These findings fail to show that either the LNG-IUS or thermal balloon ablation is superior to the other approach as a means of safely reducing blood loss in women with heavy menstrual bleeding. For this reason, individual preference should form the basis of choosing between these methods.