Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria
NCT ID: NCT04049019
Last Updated: 2023-07-07
Study Results
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Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-08-01
2022-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Urine collection, children with nocturnal enuresis
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.
Urine collection through a collecting device (Uridome®) for maximum 1 week
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.
Urine collection, healthy children
The child ́s weight and height will be registered. The children's urine will be tested for infection with a dipstick urinalysis.
Urine collection
The child will collect:
* Urine at bedtime.
* First morning voided volume
Interventions
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Urine collection through a collecting device (Uridome®) for maximum 1 week
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.
Urine collection
The child will collect:
* Urine at bedtime.
* First morning voided volume
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Furthermore, we will include 10 children without nocturnal enuresis and otherwise healthy.
6 Years
14 Years
MALE
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Søren Rittig, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus, Jylland, Denmark
Countries
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References
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von Gontard A, Heron J, Joinson C. Family history of nocturnal enuresis and urinary incontinence: results from a large epidemiological study. J Urol. 2011 Jun;185(6):2303-6. doi: 10.1016/j.juro.2011.02.040. Epub 2011 Apr 21.
Butler RJ, Heron J. The prevalence of infrequent bedwetting and nocturnal enuresis in childhood. A large British cohort. Scand J Urol Nephrol. 2008;42(3):257-64. doi: 10.1080/00365590701748054.
Yeung CK, Sihoe JD, Sit FK, Bower W, Sreedhar B, Lau J. Characteristics of primary nocturnal enuresis in adults: an epidemiological study. BJU Int. 2004 Feb;93(3):341-5. doi: 10.1111/j.1464-410x.2003.04612.x.
Van Tijen NM, Messer AP, Namdar Z. Perceived stress of nocturnal enuresis in childhood. Br J Urol. 1998 May;81 Suppl 3:98-9. doi: 10.1046/j.1464-410x.1998.00018.x. No abstract available.
Hagglof B, Andren O, Bergstrom E, Marklund L, Wendelius M. Self-esteem in children with nocturnal enuresis and urinary incontinence: improvement of self-esteem after treatment. Eur Urol. 1998;33 Suppl 3:16-9. doi: 10.1159/000052236.
Neveus T, Eggert P, Evans J, Macedo A, Rittig S, Tekgul S, Vande Walle J, Yeung CK, Robson L; International Children's Continence Society. Evaluation of and treatment for monosymptomatic enuresis: a standardization document from the International Children's Continence Society. J Urol. 2010 Feb;183(2):441-7. doi: 10.1016/j.juro.2009.10.043. Epub 2009 Dec 14.
Yeung CK, Chiu HN, Sit FK. Bladder dysfunction in children with refractory monosymptomatic primary nocturnal enuresis. J Urol. 1999 Sep;162(3 Pt 2):1049-54; discussion 1054-5. doi: 10.1016/S0022-5347(01)68062-5.
Hunsballe JM, Hansen TK, Rittig S, Pedersen EB, Djurhuus JC. The efficacy of DDAVP is related to the circadian rhythm of urine output in patients with persisting nocturnal enuresis. Clin Endocrinol (Oxf). 1998 Dec;49(6):793-801. doi: 10.1046/j.1365-2265.1998.00587.x.
Rittig S, Knudsen UB, Norgaard JP, Pedersen EB, Djurhuus JC. Abnormal diurnal rhythm of plasma vasopressin and urinary output in patients with enuresis. Am J Physiol. 1989 Apr;256(4 Pt 2):F664-71. doi: 10.1152/ajprenal.1989.256.4.F664.
Neveus T, Lackgren G, Tuvemo T, Hetta J, Hjalmas K, Stenberg A. Enuresis--background and treatment. Scand J Urol Nephrol Suppl. 2000;(206):1-44.
Kamperis K, Hagstroem S, Rittig S, Djurhuus JC. Combination of the enuresis alarm and desmopressin: second line treatment for nocturnal enuresis. J Urol. 2008 Mar;179(3):1128-31. doi: 10.1016/j.juro.2007.10.088. Epub 2008 Jan 18.
Dodds PR. Re: Evaluation of and treatment for monosymptomatic enuresis: a standardization document from the International Children's Continence Society: T. Neveus, P. Eggert, J. Evans, A. Macedo, S. Rittig, S. Tekgul, J. Vande Walle, C. K. Yeung and L. Robson J Urol 2010; 183: 441-447. J Urol. 2010 Aug;184(2):806-7; author reply 807-8. doi: 10.1016/j.juro.2010.04.006. No abstract available.
Andersen RF, Palmfeldt J, Jespersen B, Gregersen N, Rittig S. Plasma and urine proteomic profiles in childhood idiopathic nephrotic syndrome. Proteomics Clin Appl. 2012 Aug;6(7-8):382-93. doi: 10.1002/prca.201100081.
Rittig S, Frokiaer J. Basis and therapeutical rationale of the urinary concentrating mechanism. Int J Clin Pract Suppl. 2007 Sep;(155):2-7. doi: 10.1111/j.1742-1241.2007.01461.x.
Fernandez-Guerra P, Birkler RI, Merinero B, Ugarte M, Gregersen N, Rodriguez-Pombo P, Bross P, Palmfeldt J. Selected reaction monitoring as an effective method for reliable quantification of disease-associated proteins in maple syrup urine disease. Mol Genet Genomic Med. 2014 Sep;2(5):383-92. doi: 10.1002/mgg3.88. Epub 2014 Jun 4.
Other Identifiers
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Biomarkers in MNE
Identifier Type: -
Identifier Source: org_study_id
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