TY - JOUR
T1 - Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding
T2 - A multicentre randomised controlled trial
AU - Herman, Malou C.
AU - van den Brink, Marian J.
AU - Geomini, Peggy M.
AU - van Meurs, Hannah S.
AU - Huirne, Judith A.
AU - Eising, Heleen P.
AU - Timmermans, Anne
AU - Pijnenborg, Johanna M.A.
AU - Klinkert, Ellen R.
AU - Coppus, Sjors F.
AU - Nieboer, Theodoor E.
AU - Catshoek, Ruby
AU - van der Voet, Lucet F.
AU - van Eijndhoven, Hugo W.F.
AU - Graziosi, Giuseppe C.M.
AU - Veersema, Sebastiaan
AU - van Kesteren, Paul J.
AU - Langenveld, Josje
AU - Smeets, Nicol A.C.
AU - van Vliet, Huib A.A.M.
AU - van der Steeg, Jan Willem
AU - Lisman-van Leeuwen, Yvonne
AU - Dekker, Janny H.
AU - Mol, Ben W.
AU - Berger, Marjolein Y.
AU - Bongers, Marlies Y.
PY - 2013/8/8
Y1 - 2013/8/8
N2 - 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/design: A multicenter randomised controlled trial, organised 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.Discusson: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding.Trial registration: Dutch trial register, number NTR2984.
AB - 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/design: A multicenter randomised controlled trial, organised 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.Discusson: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding.Trial registration: Dutch trial register, number NTR2984.
KW - Endometrial ablation
KW - Heavy menstrual bleeding
KW - LNG-IUS
UR - http://www.scopus.com/inward/record.url?scp=84884324692&partnerID=8YFLogxK
U2 - 10.1186/1472-6874-13-32
DO - 10.1186/1472-6874-13-32
M3 - Article
C2 - 23927387
AN - SCOPUS:84884324692
SN - 1472-6874
VL - 13
JO - BMC Women's Health
JF - BMC Women's Health
IS - 1
M1 - 32
ER -