DRUG
Desmopressin lyophilisate (Melt)
Patient receives Desmopressin lyophilisate (Melt).
Status
Completed
Phase
Phase 4
Enrollment
30
Locations
1
Results
Not posted
Publications
1
Study 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.
Interventions
DRUG
Patient receives Desmopressin lyophilisate (Melt).
Timeline
First posted
Jul 20, 2012
Study start
Apr 2011
Primary completion
Aug 2012
Study completion
Aug 2012
Results posted
Not reported
Registry updated
Dec 15, 2022
Outcomes
Bladder information: voiding calender
Time frame · Change between day 1 before start of studymedication and 6 months later
Voiding calendar
Urine concentration
Time frame · Change between day 1 before start of studymedication and 6 months later
Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality
IQ (Intelligent Quotient)
Time frame · Change between day 1 before start of studymedication and 6 months later
Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version
Psychological functioning questionnaire
Time frame · Change between day 1 before start of studymedication and 6 months later
Child Behavior Checklist - CBCL (parents)
Psychological functioning questionnaire
Time frame · Change between day 1 before start of studymedication and 6 months later
"Vragenlijst voor Gedragsproblemen bij Kinderen" (VvGK): questionnaire to screen for ADHD and behavioral disorders (parents, teacher)
Psychological functioning questionnaire
Time frame · Change between day 1 before start of studymedication and 6 months later
TRF: Teacher Report Form (teacher)
Psychological functioning questionnaire
Time frame · Change between day 1 before start of studymedication and 6 months later
Behavior Rating Inventory of Executive Function (BRIEF): questionnaire to assess executive functions) (parents, teacher)
Psychological functioning questionnaire
Time frame · Change between day 1 before start of studymedication and 6 months later
Pediatric Incontinence Questionniare (PinQ): questionnaire to measure health related quality of life, specific enuresis (parents + child)
Not reported in the indexed record.
Eligibility
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
Study locations
Belgium. Showing up to 24 locations stored in the fast local snapshot.
Ghent University Hospital
Ghent, Belgium
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