Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

Pleun Beelen*, Marian J. van den Brink, Malou C. Herman, Peggy M.A.J. Geomini, Janny H. Dekker, Ruben G. Duijnhoven, Nienke Mak, Hannah S. van Meurs, Sjors F. Coppus, Jan Willem van der Steeg, Heleen P. Eising, Diana S. Massop-Helmink, Ellen R. Klinkert, Theodoor E. Nieboer, Anne Timmermans, Lucet F. van der Voet, Sebastiaan Veersema, Nicol A.C. Smeets, Joke M. Schutte, Marchien van BaalPatrick M. Bossuyt, Ben Willem J. Mol, Marjolein Y. Berger, Marlies Y. Bongers

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

Background: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. Objective: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. Study Design: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention 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-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3–96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, and 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49–4.68). There was no significant difference in patient satisfaction and quality of life between the groups. Conclusion: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies 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 noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with 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 2 treatments.

Original languageEnglish
Pages (from-to)187e.1-197e.10
Number of pages10
JournalAmerican Journal of Obstetrics and Gynecology
Volume224
Issue number2
Early online date11 Aug 2020
DOIs
Publication statusPublished - Feb 2021

Keywords

  • excessive uterine bleeding
  • intrauterine device
  • menorrhagia
  • Mirena
  • NovaSure
  • Menorrhagia/physiopathology
  • Contraceptive Agents, Hormonal/administration & dosage
  • Humans
  • Middle Aged
  • Sexual Health
  • Treatment Outcome
  • Endometrial Ablation Techniques/methods
  • Levonorgestrel/administration & dosage
  • Intrauterine Devices, Medicated
  • Patient Satisfaction
  • Retreatment
  • Netherlands
  • Quality of Life
  • Adult
  • Female

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