AzTrials
AzTrials

Monosymptomatic Nocturnal EnuresisPhase 4SLEEPNCT01645475

Desmopressin Melt: Impact on Sleep and Daytime Functioning

A Phase 4 study testing Desmopressin lyophilisate (Melt) in people with Monosymptomatic Nocturnal Enuresis, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Monosymptomatic Nocturnal Enuresis
What is being tested?
Desmopressin lyophilisate (Melt)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBelgium
Study dates
Apr 2011to Aug 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

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

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.

Read more

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.

Being tested
Desmopressin lyophilisate (Melt)
Keywords
enuresis
Medical subject headings
Enuresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desmopressin lyophilisate (Melt)Drug

    Patient receives Desmopressin lyophilisate (Melt).

Study groups in NCT01645475
Study groupRoleWhat they receive
Desmopressin lyophilisate (Melt)ExperimentalPatients receiving Desmopressin lyophilisate (Melt).
Receives: Drug: Desmopressin lyophilisate (Melt)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bladder information: voiding calender

    Voiding calendar

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

  2. Urine concentration

    Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality

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

  3. IQ (Intelligent Quotient)

    Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version

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

  4. Psychological functioning questionnaire

    Child Behavior Checklist - CBCL (parents)

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

  5. Psychological functioning questionnaire

    "Vragenlijst voor Gedragsproblemen bij Kinderen" (VvGK): questionnaire to screen for ADHD and behavioral disorders (parents, teacher)

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

  6. Psychological functioning questionnaire

    TRF: Teacher Report Form (teacher)

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

  7. Psychological functioning questionnaire

    Behavior Rating Inventory of Executive Function (BRIEF): questionnaire to assess executive functions) (parents, teacher)

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

  8. Psychological functioning questionnaire

    Pediatric Incontinence Questionniare (PinQ): questionnaire to measure health related quality of life, specific enuresis (parents + child)

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

  9. Psychological functioning questionnaire

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

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

  10. Psychological functioning questionnaire

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

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

  11. Psychological functioning questionnaire

    Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)

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

  12. 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)

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

  13. Psychological functioning questionnaire

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

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

  14. 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)

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

  15. Psychological functioning questionnaire

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

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

  16. Psychological functioning questionnaire

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

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

  17. Sleep

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

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

  18. Sleep

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

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

  19. Sleep

    Polysomnography (overnight hospitalization) (child)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2012 (estimated)
  2. Study startApr 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01645475
Sponsor's protocol ID
2010/247
Acronym
SLEEP
Status last verified
Dec 2014
First submitted
13 Jul 2012
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27067081

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Desmopressin lyophilisate (Melt) in people with Monosymptomatic Nocturnal Enuresis, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bladder information: voiding calender (time frame: Change between day 1 before start of studymedication and 6 months later). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01645475, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.

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