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MIRA Study

RCT comparing the levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation in women suffering from menorrhagia.

Go to the MIRA website.

Objective
A levonorgestrel releasing intrauterine system (LNG-IUS) and endometrial ablation are two frequently used methods for the treatment of menorrhagia, of which the first can be applied by a general practitioner or a gynaecologist, whereas the second is exclusively applied by a gynaecologist. We plan to compare the costs and effects of both methods.

Study design
Randomised controlled trial with a cost-effectiveness analysis alongside it. Non-randomised patients, who have a preference for one of the treatments, will also be followed and included in the analysis.

Study population
Women without child wish suffering from menorrhagia, in whom medical treatment has failed, or was contraindicated or unacceptable to the patient. Before study entry, the menorrhagia will be quantified by a pictorial blood assessment chart (PBAC)

Methods
We will assess cost-effectiveness of two methods that are frequently used in daily practice: a strategy starting with a levonorgestrel releasing intrauterine system placed versus a strategy starting with an endometrial ablation for the treatment of menorrhagia.

Outcome measures
Primary outcome is the number of months that women are satisfied with the treatment result during a follow-up period of 24 months. Secondary outcomes are complications, number of re-interventions, menstrual bleeding pattern, including rates of amenorrhea, mean blood loss per month (PBAC score), quality of life, sexual function, sick leave and costs.

Power/data analysis
Using an equivalence assumption with a 90% satisfaction rate for both groups and an acceptable difference of at maximum 15%, and a drop out rate of 10%, we need to include 314 women (157 women per arm) (alpha error 5% Beta error 20%).

Economic evaluation
The economic evaluation will be conducted from a societal perspective. Cost-effectiveness and cost-utility analyses will be performed and uncertainty presented on cost-effectiveness planes. Acceptability curves will be presented as well and sensitivity analyses performed on the most important cost drivers.

Time schedule
From January 2012 till May 2016. The initiation phase will take four months. Recruitment and inclusion phase in 18 months with a follow-up of 24 months. Analysis will take place from end 2015 to May 2016.

Projectleaders
Prof. dr. M.Y. Berger, huisarts/epidemioloog, Universitair Medisch Centrum Groningen
Dr. M.Y.Bongers, gynaecoloog, Maxima Medisch Centrum Veldhoven
Prof. Dr. B.W. Mol, gynaecoloog/epidemioloog, Academisch Medisch Centrum Amsterdam

Subsidy
Zon Mw.

Contact
Malou Herman
Arts-onderzoeker
Maxima Medisch Centrum Veldhoven
e-mail: m.herman@mmc.nl
tel: 06 16173155