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

• Status: Completed
• Conditions: Nocturnal Enuresis
• Intervention / Treatment: Other: blood sampling

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children at the Age of 5-16 years with monosymptomatic enuresis nocturna

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?

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	morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University Children's Hospital Basel
• 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): January 1, 2016
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: children; copeptin; desmopressin
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Kidney Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Endocrine System Diseases; Urination Disorders; Pituitary Diseases; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis; Diabetes Insipidus
• Other Study ID Numbers: EK 2015-340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO