PSG in Valproate-induced Nocturnal Enuresis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Nocturnal enuresis
研究概览
简要总结
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."
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epileptic children kept up on valproate monotherapy and developed nocturnal enuresis.
- •Age ranged 5 up to 15 years.
排除标准
- •Combined therapy with other antiepileptic drugs,
- •Abnormal cerebral imaging,
- •Poor seizure control,
- •Primary nocturnal enuresis (a child didn't accomplish any times of evening dryness -over a time of 6 successive months).
- •Congenital or acquired defects of the nervous system.
- •Urinary system anomalies, or
- •Intellectual disability.
研究组 & 干预措施
Children with enuresis
28 epileptic children with induced secondary nocturnal enuresis in valproate monotherapy.
干预措施: Clinical, EEG and laboratory assessment at presentation (Other)
Children with enuresis
28 epileptic children with induced secondary nocturnal enuresis in valproate monotherapy.
干预措施: Valproate (Drug)
Children without enuresis
232 epileptic children without induced secondary nocturnal enuresis in valproate monotherapy.
干预措施: Clinical, EEG and laboratory assessment at presentation (Other)
Children without enuresis
232 epileptic children without induced secondary nocturnal enuresis in valproate monotherapy.
干预措施: Valproate (Drug)
结局指标
主要结局
Nocturnal enuresis
时间窗: 6 months
Follow-up at least monthly interval for 6 month for the children kept on valproate monotherapy. The incidence of nocturnal enuresis and its frequency were reported
次要结局
- Side effects of valproic acid(6 month)
研究者
Ahmed Esmael
Assistant Prof of Neurology
Mansoura University Hospital