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

Disclosures

BMC Womens Health. 2013;13(32) 

In This Article

Background

Heavy menstrual bleeding is a frequent problem that affects many premenopausal women in the Netherlands and is the most important reason for a visit a the outpatient department of gynaecology.[1,2] Each year one in 20 women between 30 to 49 years of age consult their general practitioner (GP) with heavy menstrual bleeding. Hormonal treatment with the oral contraceptive pill or the levonorgestrel releasing intra uterine system (LNG-IUS) or non-hormonal treatment with tranexamic acid or non-steroidal anti-inflammatory drugs (NSAID) are advised as treatments of first choice. Nevertheless 77% of the women are not willing to continue their treatment and often end up undergoing other treatment or even surgery.[3,4]

Hysterectomy is a definitive solution for the treatment of heavy menstrual bleeding, and in 2010 11,038 women underwent a hysterectomy due to bleeding disorders in the Netherlands.[5] Recently it was reported that hysterectomy should be considered the preferred strategy for the treatment of heavy menstrual bleeding based on cost-effectiveness.[6] Nevertheless, it is a major surgical procedure and has significant physical complications and social and economic costs.[7] A significant number of women with heavy menstrual bleeding who seek treatment will not benefit from, or will not wish to continue the medical treatment and are keen to preserve their uterus.[3,8] Many women opt for a less invasive treatment, even when they are informed of the fact that success is not always assured.[1,9]

Two frequently used minimally invasive treatment options for heavy menstrual bleeding are the LNG-IUS and endometrial ablation.

Intrauterine devices were initially introduced as contraceptives, but after the addition of progestagen (LNG-IUS) these devices also reduce menstrual bleeding effectively. The local release of levonorgestrel in the uterine cavity suppresses endometrial growth. A systematic review on the effectiveness of the LNG-IUS in heavy menstrual bleeding concluded that the reduction of menstrual blood loss was 79–96% in the LNG-IUS group.[10–13] In women with heavy menstrual bleeding who presented to primary care providers, the LNG-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life.[14] However, up to 60% of women discontinue LNG-IUS within 5 years because of unscheduled bleeding, pain, and/or systemic progestogenic side-effects.[15] In the Royal College of Obstetricians and Gynaecologists (RCOG) guideline on heavy menstrual bleeding, the use of the LNG-IUS is the first therapeutic option when drug treatment has failed. This is not based on proven cost-effectiveness.[15]

Endometrial destruction techniques, which aim to destroy or remove the endometrial tissue, have become alternatives to hysterectomies. In 1991 in the Netherlands 21,433 hysterectomies were performed, a number that was reduced to 16,320 in 1998 and just above 11,000 in 2010, which was partly due to the start of using endometrial ablation.[16] Approximately 47–58% percent of women report an amenorrhea after treatment with the bipolar ablation device.[5,17–20] The satisfaction rates of endometrial ablation have been evaluated by several randomised controlled trials and is showing a rate of about 90%.[19,21,22] Ablation techniques result in shorter duration of surgery, shorter hospital stay and quicker recovery time compared to hysterectomy.

Seven trials compared the LNG- IUS with transcervical resection of the endometrium or balloon abaltion. In the meta-analyses a significant lower mean pictorial blood chart score (PBAC) was reported for all women and a significant lower mean reduction in pictorial blood chart score was reported in the surgical group. One study showed a significantly lower median PBAC score in the LNG-IUS group at nine months and one year follow-up 23. Further outcomes showed no difference in satisfaction rates, amenorrhea rates, duration of menstruation, further surgical treatment or quality of life (QoL). Nevertheless, the studies are small, most studies have a short period of follow-up and contain a lot of non-compliance, which makes interpretation of outcomes difficult.[12,20,23–27]

Consequently, usual care in the Netherlands implies one of these two strategies for the treatment of heavy menstrual bleeding if drug therapy fails. The strategy LNG-IUS means prescription and placement by the general practitioner (GP) or gynaecologist without anaesthesia. The strategy endometrial ablation implies performing an endometrial ablation by a gynaecologist in day-care or outpatient clinic with or without general anaesthesia. Due to lack of sufficiently powered studies directly comparing LNG-IUS with endometrial ablation, there is currently no evidence based advice for the use of one of these treatment possibilities.

We propose a randomised controlled trial in which these two strategies are compared in the treatment of heavy menstrual bleeding. The study will focus on (cost-) effectiveness, patient satisfaction and QoL.

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