Desmopressin Melt: Impact on Sleep and Daytime Functioning

Study Overview
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Brief Summary
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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.

Official Title
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Desmopressin Melt: Impact on Sleep and Daytime Functioning? A Prospective Study.

Conditions
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Monosymptomatic Nocturnal Enuresis

Intervention / Treatment
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* Drug: Desmopressin lyophilisate (Melt)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmopressin lyophilisate (Melt)<br>Patients receiving Desmopressin lyophilisate (Melt). | Drug: Desmopressin lyophilisate (Melt)<br>* Patient receives Desmopressin lyophilisate (Melt).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder information: voiding calender | Voiding calendar | 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 | 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 | Change between day 1 before start of studymedication and 6 months later | 
| Psychological functioning questionnaire | Child Behavior Checklist - CBCL (parents) | 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) | Change between day 1 before start of studymedication and 6 months later | 
| Psychological functioning questionnaire | TRF: Teacher Report Form (teacher) | 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) | 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) | 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) | 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) | Change between day 1 before start of studymedication and 6 months later | 
| Psychological functioning questionnaire | Cambridge Neuropsychological Test Automated Battery (CANTAB) (child) | 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) | 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) | 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) | 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) | Change between day 1 before start of studymedication and 6 months later | 
| Psychological functioning questionnaire | School results: copy of schoolreport (+median) (teacher) | Change between day 1 before start of studymedication and 6 months later | 
| Sleep | Pediatric Sleep Questionnaire (questionnaire to assess the quality of sleep) (parents) | Change between day 1 before start of studymedication and 6 months later | 
| Sleep | Children's Sleep Habits Questionnaire (CSHQ) (parents) | Change between day 1 before start of studymedication and 6 months later | 
| Sleep | Polysomnography (overnight hospitalization) (child) | Change between day 1 before start of studymedication and 6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enuresis