Desmopressin Melt: Impact on Sleep and Daytime Functioning

Monosymptomatic Nocturnal Enuresis Clinical Trial

— SLEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645475
• Other study ID #: 2010/247
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

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

Related Conditions & MeSH terms

• Enuresis
• Monosymptomatic Nocturnal Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Drug:
• Desmopressin lyophilisate (Melt)
Patient receives Desmopressin lyophilisate (Melt).

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Ferring Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

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

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