Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis &

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04049019
Study type	Interventional
Source	University of Aarhus
Contact
Status	Completed
Phase	N/A
Start date	August 1, 2019
Completion date	September 1, 2022

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms