Nocturnal EnuresisNCT04049019
Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria
A study testing Urine collection through a collecting device (Uridome®) for maximum 1 week and Urine collection in people with Nocturnal Enuresis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years, men only
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Urine collection through a collecting device (Uridome®) for maximum 1 week and Urine collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2019to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus, Jylland, 8200
About this study
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.
Read the 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 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:
- 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
- Nocturnal Enuresis
- Being tested
- Urine collection through a collecting device (Uridome®) for maximum 1 week, Urine collection
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collection through a collecting device (Uridome®) for maximum 1 weekDiagnostic 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 collectionDiagnostic test
The child will collect:
- Urine at bedtime.
- First morning voided volume
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteins.
By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.
Measured: Up to 1 week.
Metabolites.
By targeted mass spectrometry.
Measured: Up to 1 week.
Secondary outcomes (3)
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.
Measured: Up to 1 week.
Concentration of creatinine in the urine samples.
A level for the "dry night" and "wet night" will be calculated.
Measured: 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.
Measured: Up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 10 boys with nocturnal enuresis and 10 healthy boys will be included for urine collection.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Rittig, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049019
- Sponsor's protocol ID
- Biomarkers in MNE
- Status last verified
- Jul 2023
- First submitted
- 1 Aug 2019
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 21511300Butler 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.
PubMed 18432533Yeung 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.
PubMed 14764133Van 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.
PubMed 9634030Hagglof 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.
PubMed 9599731Neveus 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.
PubMed 20006865Yeung 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.
PubMed 10458430Hunsballe 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.
PubMed 10209568Rittig 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.
PubMed 2705537Neveus T, Lackgren G, Tuvemo T, Hetta J, Hjalmas K, Stenberg A. Enuresis--background and treatment. Scand J Urol Nephrol Suppl. 2000;(206):1-44.
PubMed 11196246Kamperis 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.
PubMed 18206924Dodds 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.
PubMed 20579671Andersen 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.
PubMed 22927352Rittig 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.
PubMed 17727573Fernandez-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.
PubMed 25333063
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria
- ClinicalTrials.gov ID
- NCT04049019
- Acronym / sponsor ID
- Biomarkers in MNE
- Conditions
- Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 boys with nocturnal enuresis and 10 healthy boys will be included for urine collection.
| Arm | Type | Receives |
|---|---|---|
| Urine collection, children with nocturnal enuresis | Experimental | Diagnostic Test: Urine collection through a collecting device (Uridome®) for maximum 1 weekThe 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, healthy children | Active comparator | Diagnostic Test: Urine collectionThe child ́s weight and height will be registered. The children's urine will be tested for infection with a dipstick urinalysis. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine collection through a collecting device (Uridome®) for maximum 1 weekThe 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. | Diagnostic test | Urine collection, children with nocturnal enuresis |
| Urine collectionThe child will collect: * Urine at bedtime. * First morning voided volume | Diagnostic test | Urine collection, healthy children |
Primary outcome
Proteins.
Time frame: Up to 1 week.
By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.
Metabolites.
Time frame: Up to 1 week.
By targeted mass spectrometry.
3 secondary outcomes
Total urine volume in each sample.
Time frame: Up to 1 week.
Concentration of creatinine in the urine samples.
Time frame: Up to 1 week.
Osmolality in the urine samples.
Time frame: Up to 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 21511300von 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.
- Background: PubMed 18432533Butler 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.
- Background: PubMed 14764133Yeung 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.
- Background: PubMed 9634030Van 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.
- Background: PubMed 9599731Hagglof 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.
- Background: PubMed 20006865Neveus 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.
- Background: PubMed 10458430Yeung 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.
- Background: PubMed 10209568Hunsballe 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.
- Background: PubMed 2705537Rittig 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.
- Background: PubMed 11196246Neveus T, Lackgren G, Tuvemo T, Hetta J, Hjalmas K, Stenberg A. Enuresis--background and treatment. Scand J Urol Nephrol Suppl. 2000;(206):1-44.
- Background: PubMed 18206924Kamperis 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.
- Background: PubMed 20579671Dodds 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Rittig, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine collection through a collecting device (Uridome®) for maximum 1 week and Urine collection in people with Nocturnal Enuresis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteins. (time frame: Up to 1 week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049019, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.