OTHER
blood sampling
At 4 visits capillary blood sampling for copeptin measurement will be performed with each child.
Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
Status
Completed
Phase
Not applicable
Enrollment
28
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism. The only available medical treatment option is the vasopressin analogum Desmopressin®. However, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension. Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in patients with MEN compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 3, 2015
Study start
Jan 1, 2016
Primary completion
Jun 30, 2021
Study completion
Jun 30, 2021
Results posted
Not reported
Registry updated
Dec 13, 2021
Outcomes
What the study measures.
Primary outcomes
Change of copeptin at baseline and after 28 days during routine desmopressin therapy
Time frame · morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 5 Years
- Maximum age
- 16 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Children at the age between 5 and 16 years * Diagnosis of monosymptomatic nocturnal enuresis * Completion of uroflowmetry and bladder sonography if possible * Completion of home recording charts of bed wetting episodes if possible * Willingness to use Desmopressin® treatment Exclusion Criteria: * Children with daytime enuresis * Children with lower urinary tract symptoms and infection * Children with structural abnormalities of the urinary tract * Children with chronic illness, esp. renal failure, hypertension, congenital heart disease, diabetes mellitus and diabetes insipidus.
Study locations
1 registered sites.
Switzerland. Showing up to 24 locations stored in the fast local snapshot.
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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