Levonorgestrel Releasing Intrauterine System (Mirena) versus Endometrial Ablation (Novasure) in Women With Heavy Menstrual Bleeding

A Multicentre Randomised Controlled Trial

Malou C Herman; Marian J van den Brink; Peggy M Geomini; Hannah S van Meurs; Judith A Huirne; Heleen P Eising; Anne Timmermans; Johanna MA Pijnenborg; Ellen R Klinkert; Sjors F Coppus; Theodoor E Nieboer; Ruby Catshoek; Lucet F van der Voet; Hugo WF van Eijndhoven; Giuseppe CM Graziosi; Sebastiaan Veersema; Paul J van Kesteren; Josje Langenveld; Nicol AC Smeets; Huib AAM van Vliet; Jan Willem van der Steeg; Yvonne Lisman-van Leeuwen; Janny H Dekker; Ben W Mol; Marjolein Y Berger; Marlies Y Bongers


BMC Womens Health. 2013;13(32) 

In This Article


In view of its high prevalence, an optimal treatment for heavy menstrual bleeding is of utmost importance. Usual care in The Netherlands implies two strategies for the treatment of heavy menstrual bleeding if drug therapy fails: first, there is the LNG-IUS that can be applied easily by the GP, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Large randomised controlled trials comparing LNG-IUS with endometrial ablation are lacking and hence no preferred advice for the use of one of these treatment possibilities is available. When we estimate that treatment for heavy menstrual bleeding involves 10,000 women annually, there can be a potential saving from implementing the best strategy as appears from the proposed study. Therefore, a direct comparison of both strategies on cost-effectiveness is essential to determine which strategy should be advocated.

This is the first study comparing LNG-IUS and endometrial ablation which will be organized in a network infrastructure in which both GP's and gynaecologists collaborate. It has got the largest study population compared to other trials and has a longterm follow-up of 2 years. Besides the objective outcome PBAC we also measure patient satisfaction, QoL and sexual function. Due to this study design and outcome measures, the results will be applicable for a large group of women suffering from heavy menstrual bleeding.