Title |
Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial
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Published in |
BMC Women's Health, August 2013
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DOI | 10.1186/1472-6874-13-32 |
Pubmed ID | |
Authors |
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 |
Abstract |
Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, 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. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities.Method/designA multicenter randomised controlled trial, organized in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate.Women >= 34 years with heavy menstrual bleeding, a Pictorial Blood Assessment Chart (PBAC) score exceeding 150 points and no future child wish can participate in the trial. After informed consent, women will be randomised to a strategy starting with a levonorgestrel releasing intrauterine system or a strategy starting with endometrial ablation.The primary outcome is the PBAC score at 24 months of follow-up. Secondary outcomes are patient satisfaction, complications, number of re-interventions, menstrual bleeding pattern, quality of life, sexual function, sick leave and costs. As predictors of effect of intervention we also meaure level of coagulation factors.DiscussonThis study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding.Trial registrationDutch trial register, number NTR2984. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Netherlands | 1 | 50% |
Unknown | 1 | 50% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 1 | 50% |
Scientists | 1 | 50% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | 1% |
Australia | 1 | 1% |
Unknown | 82 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Ph. D. Student | 14 | 17% |
Researcher | 11 | 13% |
Student > Master | 11 | 13% |
Student > Bachelor | 9 | 11% |
Student > Postgraduate | 7 | 8% |
Other | 12 | 14% |
Unknown | 20 | 24% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 39 | 46% |
Nursing and Health Professions | 6 | 7% |
Biochemistry, Genetics and Molecular Biology | 4 | 5% |
Social Sciences | 3 | 4% |
Agricultural and Biological Sciences | 2 | 2% |
Other | 9 | 11% |
Unknown | 21 | 25% |