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

NCT ID: NCT02621736

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-06-30

Brief Summary

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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

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Conditions

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Nocturnal Enuresis

Keywords

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children desmopressin copeptin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood sampling

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mirjam Christ-Crain, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK 2015-340

Identifier Type: -

Identifier Source: org_study_id