Levonorgestrel-Releasing Intrauterine System Versus Endometrial Ablation for Heavy Menstrual Bleeding

Abstract

ABSTRACT Background Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel intrauterine system and endometrial ablation are two frequently applied treatments in women with heavy menstrual bleeding. Objective The objective of this study is to compare the effectiveness of the levonorgestrel intrauterine system to endometrial ablation in women with heavy menstrual bleeding. Study Design This multicenter randomized controlled non-inferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel intrauterine system (Mirena) or to endometrial ablation, performed with the bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Assessment Chart (PBAC)-score. Secondary outcomes included re-intervention rates, patient satisfaction, quality of life, and sexual function. Results We registered 645 women as eligible of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel intrauterine system (baseline PBAC-score 616) and 138 women to endometrial ablation (baseline PBAC-score 630). At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)). In the levonorgestrel intrauterine system group 49 women (39%) removed the intrauterine system and 34 women (27%) underwent a surgical re-intervention, compared to 14 women (10%) in the endometrial ablation group (RR 2.64, 95% CI 1.49 to 4.68). There was no significant difference in patient satisfaction and quality of life between the groups. Conclusions Both the levonorgestrel intrauterine system and endometrial ablation strategy lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate non-inferiority of starting with the levonorgestrel intrauterine system. Women who start with the levonorgestrel intrauterine system, a reversible and less invasive treatment, are at increased risk of needing additional treatment, compared to women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the two treatments.