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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patient receives Desmopressin lyophilisate (Melt).
Ghent University Hospital
Ghent, Belgium
Bladder information: voiding calender
Voiding calendar
Time frame: Change between day 1 before start of studymedication and 6 months later
Urine concentration
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
IQ (Intelligent Quotient)
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
Psychological functioning questionnaire
Child Behavior Checklist - CBCL (parents)
Time frame: Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
"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
Psychological functioning questionnaire
TRF: Teacher Report Form (teacher)
Time frame: Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
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
Psychological functioning questionnaire
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
Psychological functioning questionnaire
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
Psychological functioning questionnaire
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
Psychological functioning questionnaire
Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)
Time frame: Change between day 1 before start of studymedication and 6 months later
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)
Time frame: Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
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
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)
Time frame: Change between day 1 before start of studymedication and 6 months later
Psychological functioning questionnaire
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
Psychological functioning questionnaire
School results: copy of schoolreport (+median) (teacher)
Time frame: Change between day 1 before start of studymedication and 6 months later
Sleep
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
Sleep
Children's Sleep Habits Questionnaire (CSHQ) (parents)
Time frame: Change between day 1 before start of studymedication and 6 months later
Sleep
Polysomnography (overnight hospitalization) (child)
Time frame: Change between day 1 before start of studymedication and 6 months later
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