- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02621736
Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN). (COMEN)
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Basel-Stadt
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Basel, Basel-Stadt, Switzerland, 4031
- University Hospital Basel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mirjam Christ-Crain, Professor, University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 2015-340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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