Desmopressin Melt: Impact on Sleep and Daytime Functioning

Phase 4

Completed

• Conditions: Monosymptomatic Nocturnal Enuresis
• Interventions: Drug: Desmopressin lyophilisate (Melt)

• Registration Number: NCT01645475
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Desmopressin lyophilisate (Melt)	Desmopressin lyophilisate (Melt)	Patients receiving Desmopressin lyophilisate (Melt).

Primary Outcome Measures

Name	Time	Method
IQ (Intelligent Quotient)	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	Change between day 1 before start of studymedication and 6 months later	School results: copy of schoolreport (+median) (teacher)
Sleep	Change between day 1 before start of studymedication and 6 months later	Polysomnography (overnight hospitalization) (child)
Bladder information: voiding calender	Change between day 1 before start of studymedication and 6 months later	Voiding calendar
Urine concentration	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

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium