Epilepsy Clinical Trial
Official title:
PSG in Valproate-induced Nocturnal Enuresis in Children
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."
More than 50 years ago, valproic acid has become established as an effective broad-spectrum
antiepileptic drug. It is a drug of choice in children and adult with generalized or focal
types of epilepsy, and in generalized convulsive status epilepticus. It is used in migraine
prophylaxis, and as a modulator of chemotherapy in cancer treatment. Moreover, valproic acid
may have a potential role in neuroprotection in stroke patients and head trauma.
NE is one of the side effects of VPA treatment, and it is generally underdiagnosed or
overlooked by clinicians. A comprehensive review study, about the effects of valproic acid,
did not mention that nocturnal enuresis as an adverse event of the valproate however; more
recent study reported variable incidence of VPA‑induced NE is 2.2-24%.
The investigator's study, retrospectively evaluate the characteristics of and the risk
factors for the occurrence of nocturnal enuresis in epileptic children kept on valproate
monotherapy.
Method Participants The study was conducted on 260 children with epilepsy receiving valproate
monotherapy aged 5-15 years who attended the outpatient clinic of neurology departments,
Mansoura University Hospital, Egypt during the period Sep 2019 to Aug 2019.
Clinical, EEG and laboratory assessment at presentation
- 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.
- Patients were therefore assessed month to month for a follow up over a time of 6
sequential months, with extra visits as required dependent on seizure recurrence or side
effects.
Follow‐up at least monthly interval for 6 month for the children kept on valproate
monotherapy. Evaluation of seizure control and the reported side effects associated with
valproate by the parents were determined. In this way special consideration and directly
asking parents about the incidence of NE and its recurrence (daily and monthly) is mandatory.
The time from the initiation of valproate monotherapy to the beginning of NE, the daily dose
and the duration of treatment of valproic acid (mg/kg) at the onset of enuresis and the serum
level of valproate were reported. Also, the time of cessation of NE either spontaneous or
following discontinuation of valproate was determined.
Statistical analysis
A multivariate logistic regression analysis was carried out for the following independent
variables: age, weight, body weight, duration of treatment and daily dose of valproate, and
serum level valproate. P-value <0.05 were considered of statistically significant results.
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