Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis; Polyuria
Study type: Interventional

Summary: 
      The aim of the study is to identify protein markers in relation to the enuresis related
      nocturnal polyuria by using mass spectrometry on nocturnal urine samples. A biomarker for
      nocturnal polyuria would simplify an important part of the clinical characterization of
      enuresis patients.
    

Detailed description: 
      Involuntary voiding during sleep, nocturnal enuresis (NE), affects 7-10 % of all 7-year-olds,
      and 0.5-2 % of young adults. Night-time polyuria is one of the main pathogenic mechanisms.
      Today, the only method to diagnose nocturnal polyuria is home recordings involving diaper
      weight and registrations of first morning voids, which is very time-consuming. By using mass
      spectrometry (proteomics and metabolomics) on nocturnal urine samples from children with NE,
      the investigators aim to identify protein markers in relation to nocturnal polyuria. The
      perspective is to simplify an important part of the clinical characterization of NE patients.

      This hypothesis-generating pilot project will be performed on 10 boys with NE. The children
      will have to collect:

        -  Urine at bedtime on a wet and a dry night.

        -  Urine during a wet night through a collecting device (non-invasive).

        -  First morning voided volume following both a wet and a dry night.

      Furthermore, we will include 10 children without NE, who will collect urine during a dry
      night (first morning voided volume).

      Endpoints are any biomarkers in urine found to be associated with nocturnal polyuria.

      The proteomics and metabolomics methodologies are available at the proteomics core facility
      of Research Unit for Molecular Medicine, Dept. of Clinical Medicine, Aarhus University
      Hospital.

      Based on the analytical uncertainty of the protein analysis methods, 10 samples are
      sufficient for detecting down to two-fold alterations in protein levels (p<0.05). By using
      state of the art mass spectrometry, the difference in any protein level between 1) the total
      urine amount on a wet and a dry night, and 2) first morning voided volume on a wet and a dry
      night, will be evaluated. Furthermore, difference in urine composition between children with
      NE and healthy children will be evaluated. Student's t-test with significance level at p<0.05
      will be used.The amount of proteins in each urine sample will be correlated to the total
      amount of proteins in the respective sample.
    

Intervention name(s): Urine collection through a collecting device (Uridome®) for maximum 1 week; Urine collection
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The child will collect:
Urine at bedtime before a wet and a dry night.
Urine during a wet night through a collecting device.
First morning voided volume following both a wet and a dry night.; The child will collect:
Urine at bedtime.
First morning voided volume
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 10 boys with nocturnal enuresis and 10 healthy boys will be included for urine collection.
Masking: None (Open Label)
Primary purpose: Diagnostic