Skip to main content
Clinical Trials/NCT01645475
NCT01645475
Completed
Phase 4

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

University Hospital, Ghent1 site in 1 country30 target enrollmentApril 2011

Overview

Phase
Phase 4
Intervention
Desmopressin lyophilisate (Melt)
Conditions
Monosymptomatic Nocturnal Enuresis
Sponsor
University Hospital, Ghent
Enrollment
30
Locations
1
Primary Endpoint
IQ (Intelligent Quotient)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
August 2012
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Desmopressin lyophilisate (Melt)

Patients receiving Desmopressin lyophilisate (Melt).

Intervention: Desmopressin lyophilisate (Melt)

Outcomes

Primary Outcomes

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

School results: copy of schoolreport (+median) (teacher)

Sleep

Time Frame: Change between day 1 before start of studymedication and 6 months later

Polysomnography (overnight hospitalization) (child)

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

Study Sites (1)

Loading locations...

Similar Trials