An interventional study of Urine collection through a collecting device (Uridome®) for maximum 1 week and Urine collection in Nocturnal Enuresis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by University of Aarhus · Not applicable, Interventional, and Diagnostic
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Among 12 studies in Nocturnal Enuresis with a site in Denmark — 3 open to participants now, 3 under way, none of them phase 3. Nocturnal Enuresis · Denmark.
Among the 12 studies in Nocturnal Enuresis with a site in Denmark, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2019, is one of 8 with no phase, and was the 7th registered.
105 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.
Browse Nocturnal Enuresis studies →3 of the 12 studies in Nocturnal Enuresis with a site in Denmark are open now. Recruiting first, the newest first:
InnoCon Medical · Sites in Denmark
Ages 18+
InnoCon Medical · Sites in Denmark
Ages 18+ · Women only
Aalborg University Hospital · Sites in Denmark
Ages 6–14 · Healthy volunteers
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 14 Nocturnal Enuresis studies recruiting now, 5 (36%) set no upper age limit and 9 (64%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 6 Years to 14 Years · male · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 66 across 77 interventional studies indexed under Nocturnal Enuresis.
Median enrollment 65 across the 10 interventional studies, 52 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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3 of 12 have an industry lead sponsor. The 3 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 7 studies filed under Nocturnal Enuresis — fewer than ten, so there is no comparison to draw.
1 of the studies in Nocturnal Enuresis with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06091566InnoCon MedicalSafety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) | 2027-01-01 |
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Among the 12 studies in Nocturnal Enuresis with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
The child will collect: * Urine at bedtime. * First morning voided volume
Proteins.
By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.
Time frame: Up to 1 week.
Metabolites.
By targeted mass spectrometry.
Time frame: Up to 1 week.
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.
Time frame: Up to 1 week.
Concentration of creatinine in the urine samples.
A level for the "dry night" and "wet night" will be calculated.
Time frame: 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.
Time frame: Up to 1 week.
Plan to share: Yes
Ran from Aug 2019 to primary completion in Sep 2022, 37 months.
Of 41 interventional studies with no phase under Nocturnal Enuresis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 37 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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