Desmopressin Melt: Impact on Sleep and Daytime Functioning

NCT01645475 | Completed Phase 4

• 1 other identifier: 2010/247
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Monosymptomatic Nocturnal Enuresis

Keywords

enuresis

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (1)

Desmopressin lyophilisate (Melt)

EXPERIMENTAL

Patients receiving Desmopressin lyophilisate (Melt).

Drug: Desmopressin lyophilisate (Melt)

Interventions

Desmopressin lyophilisate (Melt) DRUG

Patient receives Desmopressin lyophilisate (Melt).

Desmopressin lyophilisate (Melt)

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• New patient
• age 6 to 16 years
• monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems

You may not qualify if:

• mental retardation
• autism spectrum disorders
• daytime incontinence resistant to therapy
• dysfunctional voiding
• poor therapy-compliance
• diuretics, antihypertensives, uropathy, renal abnormalities

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• Van Herzeele C, Dhondt K, Roels SP, Raes A, Hoebeke P, Groen LA, Vande Walle J. Desmopressin (melt) therapy in children with monosymptomatic nocturnal enuresis and nocturnal polyuria results in improved neuropsychological functioning and sleep. Pediatr Nephrol. 2016 Sep;31(9):1477-84. doi: 10.1007/s00467-016-3351-3. Epub 2016 Apr 11.

  PMID: 27067081 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Enuresis

Interventions

Freezing

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phase Transition; Physical Phenomena; Cold Temperature; Temperature; Thermodynamics; Chemical Phenomena

Study Officials

• Johan Vande Walle, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 20, 2012
• Study Start: April 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 15, 2022

Record last verified: 2014-12

Locations

BE (1)