CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 260 enrolled
Drug / intervention
Valproate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04191863
NCT04191863N/ACompleted

PSG in Valproate-induced Nocturnal Enuresis in Children

Mansoura University Hospital·observational·Posted Dec 10, 2019·Updated May 7, 2020

In Brief

An observational study evaluating Clinical, EEG and laboratory assessment at presentation and Valproate for Epilepsy and Nocturnal Enuresis. Completed, enrolled 260 participants across 1 site.

Detailed Summary

Our study, retrospectively evaluate the characteristics of and the risk factors for the occurrence of nocturnal enuresis in epileptic children kept on valproate monotherapy. Epileptic children with the age ranged 5 up to 15 years who were started and kept up on valproate monotherapy. In this study, a child determined to have nocturnal enuresis based on the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, fourth edition: "an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged 5 years or older, in the absence of congenital or acquired defects of the nervous system."

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 10, 2019
Enrollment StartSep 1, 2018
Primary CompletionJun 1, 2019
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.6 years ago

Interventions

Clinical, EEG and laboratory assessment at presentationother

* The patients' history, clinical, demographic, and laboratory data were acquired. * The following tests and imaging studies are routinely done for epilepsy patients receiving valproate treatment and developed nocturnal enuresis, blood urea nitrogen (BUN), serum creatinine (Cr), urinary pH (before and after valproate therapy beginning and at enuresis onset), serum levels and therapeutic doses of valproate. * Urinary tract ultrasonography (with full and void bladder). * CT brain and EEG.

Valproatedrug

valproate monotherapy