1. Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial
- Author
-
Marlies Y. Bongers, Nicol A. C. Smeets, Theodoor E. Nieboer, Peggy M.A.J. Geomini, Ruby Catshoek, Ellen R. Klinkert, G.C.M. Graziosi, Heleen P. Eising, Yvonne Lisman-van Leeuwen, Jan Willem van der Steeg, Anne Timmermans, Janny H. Dekker, Sebastiaan Veersema, Huib A.A.M. van Vliet, Hannah S. van Meurs, Paul J. M. van Kesteren, Marjolein Y. Berger, Judith A.F. Huirne, Marian J van den Brink, Hugo W F van Eijndhoven, Sjors F.P.J. Coppus, Lucet F. van der Voet, Josje Langenveld, Johanna M.A. Pijnenborg, Ben W.J. Mol, Malou C. Herman, Other departments, Amsterdam Public Health, Obstetrics and Gynaecology, Obstetrics and gynaecology, ICaR - Ischemia and repair, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Obstetrie & Gynaecologie, RS: GROW - School for Oncology and Reproduction, Life Course Epidemiology (LCE), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)
- Subjects
medicine.medical_treatment ,DEVICE ,Study Protocol ,Obstetrics and Gynaecology ,Contraceptive Agents, Female ,Levonorgestrel ,Endometrial ablation ,Netherlands ,media_common ,Medicine(all) ,education.field_of_study ,medicine.diagnostic_test ,Obstetrics ,Intrauterine Devices, Medicated ,Obstetrics and Gynecology ,General Medicine ,Treatment Outcome ,Hysteroscopy ,LNG-IUS ,THERMAL BALLOON ABLATION ,HYSTERECTOMY ,Female ,medicine.drug ,Adult ,medicine.medical_specialty ,endocrine system ,RESECTION ,media_common.quotation_subject ,Population ,MEDICAL THERAPY ,Genomic disorders and inherited multi-system disorders [IGMD 3] ,Young Adult ,medicine ,Humans ,Emergency contraception ,education ,Menstrual cycle ,Endometrial Ablation Techniques ,Gynecology ,Hysterectomy ,business.industry ,Heavy menstrual bleeding ,Human Reproduction [NCEBP 12] ,Reproductive Medicine ,Women's Health ,business ,IDIOPATHIC MENORRHAGIA - Abstract
Contains fulltext : 125610.pdf (Publisher’s version ) (Open Access) BACKGROUND: 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.
- Published
- 2013