Desmopressin Melt: Impact on Sleep and Daytime Functioning (SLEEP)
Primary Purpose
Monosymptomatic Nocturnal Enuresis
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Desmopressin lyophilisate (Melt)
Sponsored by
About this trial
This is an interventional treatment trial for Monosymptomatic Nocturnal Enuresis focused on measuring enuresis
Eligibility Criteria
Inclusion Criteria:
- New patient
- age 6 to 16 years
- monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems
Exclusion Criteria:
- mental retardation
- autism spectrum disorders
- daytime incontinence resistant to therapy
- dysfunctional voiding
- poor therapy-compliance
- diuretics, antihypertensives, uropathy, renal abnormalities
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Desmopressin lyophilisate (Melt)
Arm Description
Patients receiving Desmopressin lyophilisate (Melt).
Outcomes
Primary Outcome Measures
Bladder information: voiding calender
Voiding calendar
Urine concentration
Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality
IQ (Intelligent Quotient)
Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version
Psychological functioning questionnaire
Child Behavior Checklist - CBCL (parents)
Psychological functioning questionnaire
"Vragenlijst voor Gedragsproblemen bij Kinderen" (VvGK): questionnaire to screen for ADHD and behavioral disorders (parents, teacher)
Psychological functioning questionnaire
TRF: Teacher Report Form (teacher)
Psychological functioning questionnaire
Behavior Rating Inventory of Executive Function (BRIEF): questionnaire to assess executive functions) (parents, teacher)
Psychological functioning questionnaire
Pediatric Incontinence Questionniare (PinQ): questionnaire to measure health related quality of life, specific enuresis (parents + child)
Psychological functioning questionnaire
Pediatric Quality of Life Inventory (PedsQL): questionnaire to measure health related quality of life (parents + child)
Psychological functioning questionnaire
Kiddie Schedule for Affective Disorders and Schizofrenia (K-SADS): diagnostic interview if CBCL/TRF is (sub)clinical (parents + child)
Psychological functioning questionnaire
Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)
Psychological functioning questionnaire
IQ: WISC-III subtest Digit Span - children are orally given sequences of numbers and asked to repeat them, either as heard or in reverse order. (child)
Psychological functioning questionnaire
Test of Everyday Attention for Children (TEA-ch): subtest Secret code + Score DT (sustained attention task) (child)
Psychological functioning questionnaire
"Competentiebelevingsschaal voor Kinderen/Adolescenten" (CBSK/CBSA): questionnaire to measure self-esteem in children or adolescents OR The pictorial scale of perceived competence and social acceptance for young children. (child)
Psychological functioning questionnaire
Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale: observation scale (teacher)
Psychological functioning questionnaire
School results: copy of schoolreport (+median) (teacher)
Sleep
Pediatric Sleep Questionnaire (questionnaire to assess the quality of sleep) (parents)
Sleep
Children's Sleep Habits Questionnaire (CSHQ) (parents)
Sleep
Polysomnography (overnight hospitalization) (child)
Secondary Outcome Measures
Full Information
NCT ID
NCT01645475
First Posted
July 13, 2012
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
Collaborators
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01645475
Brief Title
Desmopressin Melt: Impact on Sleep and Daytime Functioning
Acronym
SLEEP
Official Title
Desmopressin Melt: Impact on Sleep and Daytime Functioning? A Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a mismatch between nocturnal bladder capacity and the amount of urine produced during the night together with failure of the child to awaken in response to a full bladder.Urine overproduction at night or nocturnal polyuria (NP) is a major factor contributing to monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.
Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion, the synthetic AVP analogue desmopressin is widely used to treat MNE.
It is recommended by the International Consultation on Incontinence (grade A,level 1). Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest form melt.
Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity disorder (ADHD) in children with MNE According to recent data there is a high incidence of periodic limb movements in sleep at night in children with nocturnal enuresis. Those children have an increased cortical arousability leading to awakening.
The frequent awakening most likely has an influence on concentration and other ADHD-symptoms in daily life.
This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms, cognition and learning, sleep, quality of life and self esteem.
New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems are tested before the start of the study medication desmopressin melt (T1) and 6 months later (T2). It is a multi-method, multi-informant study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monosymptomatic Nocturnal Enuresis
Keywords
enuresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desmopressin lyophilisate (Melt)
Arm Type
Experimental
Arm Description
Patients receiving Desmopressin lyophilisate (Melt).
Intervention Type
Drug
Intervention Name(s)
Desmopressin lyophilisate (Melt)
Intervention Description
Patient receives Desmopressin lyophilisate (Melt).
Primary Outcome Measure Information:
Title
Bladder information: voiding calender
Description
Voiding calendar
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Urine concentration
Description
Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
IQ (Intelligent Quotient)
Description
Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Child Behavior Checklist - CBCL (parents)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
"Vragenlijst voor Gedragsproblemen bij Kinderen" (VvGK): questionnaire to screen for ADHD and behavioral disorders (parents, teacher)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
TRF: Teacher Report Form (teacher)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Behavior Rating Inventory of Executive Function (BRIEF): questionnaire to assess executive functions) (parents, teacher)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Pediatric Incontinence Questionniare (PinQ): questionnaire to measure health related quality of life, specific enuresis (parents + child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Pediatric Quality of Life Inventory (PedsQL): questionnaire to measure health related quality of life (parents + child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Kiddie Schedule for Affective Disorders and Schizofrenia (K-SADS): diagnostic interview if CBCL/TRF is (sub)clinical (parents + child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
IQ: WISC-III subtest Digit Span - children are orally given sequences of numbers and asked to repeat them, either as heard or in reverse order. (child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Test of Everyday Attention for Children (TEA-ch): subtest Secret code + Score DT (sustained attention task) (child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
"Competentiebelevingsschaal voor Kinderen/Adolescenten" (CBSK/CBSA): questionnaire to measure self-esteem in children or adolescents OR The pictorial scale of perceived competence and social acceptance for young children. (child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale: observation scale (teacher)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Psychological functioning questionnaire
Description
School results: copy of schoolreport (+median) (teacher)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Sleep
Description
Pediatric Sleep Questionnaire (questionnaire to assess the quality of sleep) (parents)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Sleep
Description
Children's Sleep Habits Questionnaire (CSHQ) (parents)
Time Frame
Change between day 1 before start of studymedication and 6 months later
Title
Sleep
Description
Polysomnography (overnight hospitalization) (child)
Time Frame
Change between day 1 before start of studymedication and 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New patient
age 6 to 16 years
monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems
Exclusion Criteria:
mental retardation
autism spectrum disorders
daytime incontinence resistant to therapy
dysfunctional voiding
poor therapy-compliance
diuretics, antihypertensives, uropathy, renal abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Vande Walle, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
27067081
Citation
Van Herzeele C, Dhondt K, Roels SP, Raes A, Hoebeke P, Groen LA, Vande Walle J. Desmopressin (melt) therapy in children with monosymptomatic nocturnal enuresis and nocturnal polyuria results in improved neuropsychological functioning and sleep. Pediatr Nephrol. 2016 Sep;31(9):1477-84. doi: 10.1007/s00467-016-3351-3. Epub 2016 Apr 11.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Related Info
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Desmopressin Melt: Impact on Sleep and Daytime Functioning
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