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Trial record 6 of 168 for:    Recruiting, Not yet recruiting, Available Studies | "Enuresis"

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

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ClinicalTrials.gov Identifier: NCT02621736
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment
Nocturnal Enuresis Other: blood sampling

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
Study Start Date : January 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children at the Age of 5-16 years with monosymptomatic enuresis nocturna
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621736


Contacts
Contact: Mirjam Christ-Crain, Professor +41612652525 mirjam.christ@usb.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Mirjam Christ-Crain, MD, Prof.    +41612652525      
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Children's Hospital Basel
Investigators
Principal Investigator: Mirjam Christ-Crain, Professor University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02621736     History of Changes
Other Study ID Numbers: EK 2015-340
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Basel, Switzerland:
children
desmopressin
copeptin

Additional relevant MeSH terms:
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Urination Disorders
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs