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

NCT04049019 | Completed

• 1 other identifier: Biomarkers in MNE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nocturnal Enuresis

Outcome Measures

Primary Outcomes (2)

• Proteins.

  By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.

  Up to 1 week.

• Metabolites.

  By targeted mass spectrometry.

  Up to 1 week.

Secondary Outcomes (3)

• Total urine volume in each sample.

  Up to 1 week.

• Concentration of creatinine in the urine samples.

  Up to 1 week.

• Osmolality in the urine samples.

  Up to 1 week.

Study Arms (2)

Urine collection, children with nocturnal enuresis

EXPERIMENTAL

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

Urine collection, healthy children

ACTIVE COMPARATOR

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

Interventions

Urine collection through a collecting device (Uridome®) for maximum 1 week DIAGNOSTIC_TEST

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, children with nocturnal enuresis

Urine collection DIAGNOSTIC_TEST

The child will collect: * Urine at bedtime. * First morning voided volume

Urine collection, healthy children

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Furthermore, we will include 10 children without nocturnal enuresis and otherwise healthy.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus, Jylland, 8200, Denmark

Location

Related Publications (15)

• 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.

  PMID: 21511300 BACKGROUND

• 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.

  PMID: 18432533 BACKGROUND

• 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.

  PMID: 14764133 BACKGROUND

• 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.

  PMID: 9634030 BACKGROUND

• 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.

  PMID: 9599731 BACKGROUND

• 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.

  PMID: 20006865 BACKGROUND

• 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.

  PMID: 10458430 BACKGROUND

• 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.

  PMID: 10209568 BACKGROUND

• 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.

  PMID: 2705537 BACKGROUND

• 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.

  PMID: 11196246 BACKGROUND

• 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.

  PMID: 18206924 BACKGROUND

• 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.

  PMID: 20579671 BACKGROUND

• 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.

  PMID: 22927352 BACKGROUND

• 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.

  PMID: 17727573 BACKGROUND

• 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.

  PMID: 25333063 BACKGROUND

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Søren Rittig, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 boys with nocturnal enuresis and 10 healthy boys will be included for urine collection.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 7, 2019
• Study Start: August 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)