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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
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Diagnostic Test: Urine collection through a collecting device (Uridom®) for maximum 1 week Not Applicable

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) 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.


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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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:

  • Urine at bedtime on 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.




Primary Outcome Measures :
  1. Proteins. [ Time Frame: Up to 1 week. ]
    By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.

  2. Concentration of arginine vasopressin. [ Time Frame: Up to 1 week. ]
    By targeted mass spectrometry.

  3. Concentration of co-peptin. [ Time Frame: Up to 1 week. ]
    By targeted mass spectrometry.

  4. Concentration of aquaporins. [ Time Frame: Up to 1 week. ]
    By enzyme-linked immunosorbent assay (ELISA).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Cecilie Siggaard Jørgensen 004561161606 cecilie.siggaard@clin.au.dk

Locations
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Denmark
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital Recruiting
Aarhus, Jylland, Denmark, 8200
Contact: Cecilie Siggaard Jørgensen    004561161606    cecilie.siggaard@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Søren Rittig, MD Aarhus University Hospital

Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04049019     History of Changes
Other Study ID Numbers: Biomarkers in MNE
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Enuresis
Urinary Incontinence
Nocturnal Enuresis
Polyuria
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms