Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN). (COMEN)
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|ClinicalTrials.gov Identifier: NCT02621736|
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : April 25, 2019
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.
|Condition or disease||Intervention/treatment|
|Nocturnal Enuresis||Other: blood sampling|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
- Other: blood sampling
At 4 visits capillary blood sampling for copeptin measurement will be performed with each child.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621736
|Contact: Mirjam Christ-Crain, Professorfirstname.lastname@example.org|
|University Hospital Basel||Recruiting|
|Basel, Basel-Stadt, Switzerland, 4031|
|Contact: Mirjam Christ-Crain, MD, Prof. +41612652525|
|Principal Investigator:||Mirjam Christ-Crain, Professor||University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism|