Desmopressin Melt: Impact on Sleep and Daytime Functioning

Status

Completed

Phase

Phase 4

Enrollment

30 participants (actual)

Sponsor

University Hospital, Ghent · Other

Design

Allocation not applicable · Open label (no masking)

Countries

1 country

Belgium

Start

Apr 2011

Primary completion

Aug 2012

Completion

Aug 2012

First posted

20 Jul 2012 (estimated)

Last update posted

15 Dec 2022

Conditions

Monosymptomatic Nocturnal Enuresis

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.

• Experimental

  Desmopressin lyophilisate (Melt)

  Patients receiving Desmopressin lyophilisate (Melt).

1. Bladder information: voiding calender

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

   Registry description

   Voiding calendar

2. Urine concentration

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

   Registry description

   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

   Registry description

   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

   Registry description

   Child Behavior Checklist - CBCL (parents)

5. Psychological functioning questionnaire

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

   Registry description

   "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

   Registry description

   TRF: Teacher Report Form (teacher)

7. Psychological functioning questionnaire

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

   Registry description

   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

   Registry description

   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

   Registry description

   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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    "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

    Registry description

    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

    Registry description

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

17. Sleep

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

    Registry description

    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

    Registry description

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

19. Sleep

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

    Registry description

    Polysomnography (overnight hospitalization) (child)