The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy. The hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with MNE and subsequent treatment tailoring improves the response to first-line treatment approach.
This is a randomized, controlled study. This study will be performed at Aarhus University Hospital (Denmark), Ghent University Hospital (Belgium) and Hospital of Zhengzhou University (China) following the same protocol. According to the initial randomization, children will be allocated to treatment without (group A) or with (group B) prior clinical characterization based on home recordings. Group A: The children will be randomized to either an enuresis alarm or desmopressin without evaluating the home recordings. Group B: The home recordings will be evaluated and treatment will be based on the recordings. Desmopressin will be administered to the children with nocturnal polyuria and the conditional alarm to the children with reduced bladder capacity. Children with nocturnal polyuria and reduced bladder capacity will be treated with both desmopressin and conditional alarm. Children with neither nocturnal polyuria nor reduced bladder capacity will again be randomized to either desmopressin or alarm treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
324
The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).
Eight weeks of treatment.
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, Belgium
Ghent University Hospital
Ghent, Belgium
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Aalborg University Hospital
Aalborg, Jylland, Denmark
The number of children who responded to the treatment
Evaluated by home recordings
Time frame: Eight weeks
The number of children achieving complete dryness (complete responders)
Evaluated by home recordings
Time frame: Eight weeks
Change in wet nights
Evaluated by home recordings
Time frame: Eight weeks
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Aarhus University Hospital
Aarhus, Jylland, Denmark
University Clinical Centre in Gdańsk
Gdansk, Poland