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

NCT02621736 | Completed

• 1 other identifier: EK 2015-340
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Enuresis

Keywords

children; desmopressin; copeptin

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

blood sampling OTHER

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

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Children's Hospital Basel: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Nocturnal Enuresis; Diabetes Insipidus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Kidney Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mirjam Christ-Crain, Professor

  University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2016
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)