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

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.

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Key information

Conditions

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

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

Change of copeptin at baseline and after 28 days during routine desmopressin therapy

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

University Children's Hospital Basel

Registry information

Acronym: COMEN

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Dec 3, 2015
Registry last updated: Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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