An interventional study of Urine collection through a collecting device (Uridome®) for maximum 1 week and Urine collection in Nocturnal Enuresis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by University of Aarhus · Not applicable, Interventional, and Diagnostic
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.
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:
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.
Exclusion Criteria:
If the child is receiving treatment for nocturnal enuresis (desmopressin, alarm or anticholinergics), the treatment has to be paused 1 week before urine collection.
Furthermore, we will include 10 children without nocturnal enuresis and otherwise healthy.
The child ́s weight and height will be registered. The children's urine will be tested for infection with a dipstick urinalysis. The child will be asked to perform home recordings for seven days consisting of measurements of diaper weight and first morning voided volume and a two-day frequency-volume chart.
Diagnostic Test: Urine collection through a collecting device (Uridome®) for maximum 1 week
The child ́s weight and height will be registered. The children's urine will be tested for infection with a dipstick urinalysis.
Diagnostic Test: Urine collection
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
Proteins.
By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.
Time frame: Up to 1 week.
Metabolites.
By targeted mass spectrometry.
Time frame: Up to 1 week.
Total urine volume in each sample.
A urine volume for the "dry night" (first morning voided volume) and "wet night" (nighttime urine production + first morning voided volume) will be calculated.
Time frame: Up to 1 week.
Concentration of creatinine in the urine samples.
A level for the "dry night" and "wet night" will be calculated.
Time frame: Up to 1 week.
Osmolality in the urine samples.
By freezing-point depression. A level for the "dry night" and "wet night" will be calculated.
Time frame: Up to 1 week.
Plan to share: Yes
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of Aarhus