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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT02621736

Collaborator

University Children's Hospital Basel (Other)

Enrollment

Location

65.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nocturnal Enuresis	Other: blood sampling

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.