Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).

Completed

• Conditions: Nocturnal Enuresis

• Registration Number: NCT02621736
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Study Start: 2016-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of copeptin at baseline and after 28 days during routine desmopressin therapy	morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland