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NCT Number: NCT01645475

Desmopressin Melt: Impact on Sleep and Daytime Functioning

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.

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Key information

Conditions

Monosymptomatic Nocturnal Enuresis Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Urination Disorders Urogenital Diseases Urologic Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desmopressin lyophilisate (Melt)

Drug

Patient receives Desmopressin lyophilisate (Melt).

Primary outcomes

  1. Bladder information: voiding calender

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

    Voiding calendar

  2. 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

  3. 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

  4. Psychological functioning questionnaire

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

    Child Behavior Checklist - CBCL (parents)

  5. 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)

  6. Psychological functioning questionnaire

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

    TRF: Teacher Report Form (teacher)

  7. 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)

  8. 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)

  9. Psychological functioning questionnaire

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

    Pediatric Quality of Life Inventory (PedsQL): questionnaire to measure health related quality of life (parents + child)

  10. Psychological functioning questionnaire

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

    Kiddie Schedule for Affective Disorders and Schizofrenia (K-SADS): diagnostic interview if CBCL/TRF is (sub)clinical (parents + child)

  11. Psychological functioning questionnaire

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

    Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)

  12. Psychological functioning questionnaire

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

    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)

  13. Psychological functioning questionnaire

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

    Test of Everyday Attention for Children (TEA-ch): subtest Secret code + Score DT (sustained attention task) (child)

  14. Psychological functioning questionnaire

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

    "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)

  15. Psychological functioning questionnaire

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

    Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale: observation scale (teacher)

  16. Psychological functioning questionnaire

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

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

  17. Sleep

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

    Pediatric Sleep Questionnaire (questionnaire to assess the quality of sleep) (parents)

  18. Sleep

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

    Children's Sleep Habits Questionnaire (CSHQ) (parents)

  19. Sleep

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

    Polysomnography (overnight hospitalization) (child)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study title

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

Acronym: SLEEP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2012
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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