Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria

  • STATUS
    Recruiting
  • days left to enroll
    34
  • participants needed
    20
  • sponsor
    University of Aarhus
Updated on 14 February 2022
nocturnal enuresis
nocturnal polyuria

Summary

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

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) 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 20 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.

Together with the analysis of a broad palette of peptides and proteins in the urine, there will be performed targeted analysis of arginine vasopressin (AVP), co-peptin and aquaporins, due to our knowledge about AVP and aquaporin roles as key regulators of the water balance in the body. Endpoints are any biomarkers in urine found to be associated with nocturnal polyuria. The proteomics 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, 20 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. 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.

Details
Condition Nocturnal Enuresis
Treatment Urine collection through a collecting device (Uridom®) for maximum 1 week
Clinical Study IdentifierNCT04049019
SponsorUniversity of Aarhus
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Monosymptomatic nocturnal enuresis with at least one dry night per week
Nocturnal polyuria defined as nocturnal urine production on wet nights greater than 130 % of expected bladder capacity for age
Normal bladder capacity defined as maximum voided volume excluding first morning voided volume bigger than expected bladder capacity for age

Exclusion Criteria

Recurrent urinary tract infections
Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated
Neurological and/or known clinically significant anatomical abnormalities of the urinary tract
Former operations in the urinary tract
Ongoing medication that may interfere with the parameters tested
If the child is receiving treatment for nocturnal enuresis (desmopressin
alarm or anticholinergics), the treatment has to be paused 1 week before urine
collection
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