Current partner codePEPTIDESDE
NCT01645475·Phase 4·INTERVENTIONAL

Desmopressin Melt: Impact on Sleep and Daytime Functioning

Status

Completed

Phase

Phase 4

Enrollment

30

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Desmopressin lyophilisate (Melt)

Patient receives Desmopressin lyophilisate (Melt).

Timeline

From registration to results.

  1. First posted

    Jul 20, 2012

  2. Study start

    Apr 2011

  3. Primary completion

    Aug 2012

  4. Study completion

    Aug 2012

  5. Results posted

    Not reported

  6. Registry updated

    Dec 15, 2022

Outcomes

What the study measures.

Primary 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)

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
6 Years
Maximum age
16 Years
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

Belgium. Showing up to 24 locations stored in the fast local snapshot.

Ghent University Hospital

Ghent, Belgium

Related trials

More studies on Desmopressin.

Related PeptideStat pages

Put the record in context.

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