Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria
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|ClinicalTrials.gov Identifier: NCT04049019|
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nocturnal Enuresis||Diagnostic Test: Urine collection through a collecting device (Uridom®) for maximum 1 week||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||20 boys will be included for urine collection.|
|Masking:||None (Open Label)|
|Official Title:||Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: Urine collection
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 (Uridom®) for maximum 1 week
The child will collect:
- Proteins. [ Time Frame: Up to 1 week. ]By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.
- Concentration of arginine vasopressin. [ Time Frame: Up to 1 week. ]By targeted mass spectrometry.
- Concentration of co-peptin. [ Time Frame: Up to 1 week. ]By targeted mass spectrometry.
- Concentration of aquaporins. [ Time Frame: Up to 1 week. ]By enzyme-linked immunosorbent assay (ELISA).
- Total urine volume in each sample. [ Time Frame: Up to 1 week. ]A urine volume for the "dry night" (first morning voided volume) and "wet night" (nighttime urine production + first morning voided volume) will be calculated.
- Concentration of creatinine in the urine samples. [ Time Frame: Up to 1 week. ]A level for the "dry night" and "wet night" will be calculated.
- Osmolality in the urine samples. [ Time Frame: Up to 1 week. ]By freezing-point depression. A level for the "dry night" and "wet night" will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049019
|Contact: Cecilie Siggaard Jørgensenfirstname.lastname@example.org|
|Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital||Recruiting|
|Aarhus, Jylland, Denmark, 8200|
|Contact: Cecilie Siggaard Jørgensen 004561161606 email@example.com|
|Principal Investigator:||Søren Rittig, MD||Aarhus University Hospital|