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

Nocturnal Enuresis Clinical Trial

— COMEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621736
• Other study ID #: EK 2015-340
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Insipidus
• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Other:
• blood sampling
At 4 visits capillary blood sampling for copeptin measurement will be performed with each child.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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