Clinical trial NCT01645475: Desmopressin Melt: Impact on Sleep and Daytime Functioning
Official title: Desmopressin Melt: Impact on Sleep and Daytime Functioning? A Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Monosymptomatic Nocturnal Enuresis
Keywords: enuresis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2012-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bladder information: voiding calender
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Urine concentration
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: IQ (Intelligent Quotient)
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Psychological functioning questionnaire
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Sleep
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Sleep
timeFrame: Change between day 1 before start of studymedication and 6 months later
measure: Sleep
timeFrame: Change between day 1 before start of studymedication and 6 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Johan Vande Walle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.