Micturition Reeducation in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Subjective report of change in urinary incontinence measured by questionnaire
研究概览
简要总结
This study evaluates the effectiveness of a voiding reeducation program as treatment for incontinence in children with a brain injury.
详细描述
Children with cerebral palsy (CP) (Rosenbaum, 2007) gain bladder and bowel control at older age compared to typical developing children (Ozturk, 2006). The incidence of urinary incontinence during day and night, fecal incontinence and constipation is higher in this population.
Incontinence in children is often treated with urotherapy. This is a nonsurgical, nonpharmacological treatment for lower urinary tract dysfunctions. Standard urotherapy is noninterventional and it includes giving information, instructions, advice regarding life-style, fluid intake and bladder diaries. Additionally specific interventions can be used, such as: various forms of pelvic floor training, behavioral modification, biofeedback, electrical stimulation and catheterization (Neveus, 2006). Recent research has proven urotherapy to be successful for the treatment of children with daytime incontinence (Mulders, 2010).
Despite the high prevalence of incontinence in children with CP the possible treatment strategies in this population are poorly investigated. Far too often, urinary incontinence in children with CP is considered a normal, unavoidable and even a minor problem.
Aim: Investigate the influence of individualized urotherapy on the (in)continence of children with CP.
The included children with CP will be randomized and stratified for type of CP and mental abilities into 2 groups: the intervention group and the control group. The intervention group will receive immediate therapy. After one year of therapy, a follow- up of 6 months will be applied. The control group will start 6 months later and information will be used as control group. Incontinent children without CP will receive therapy and will also act as control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Daytime urinary incontinence with or without enuresis and/or fecal incontinence
- •Cerebral palsy (Arms of children with CP)
- •Normal development (Arms of children without CP)
排除标准
- •Isolated urinary tract infections
- •Isolated enuresis
- •Isolated dysfunctional voiding
- •Isolated fecal incontinence
- •Anatomical abnormalities
- •History of genitourinary or renal surgery
- •Medication for incontinence during the last 3 months
- •Pelvic reeducation during the last 6 months
- •other neurologic problems influencing continence
结局指标
主要结局
Subjective report of change in urinary incontinence measured by questionnaire
时间窗: Baseline and 3-6-12 months + follow-up
次要结局
- Lower urinary tract symptoms (LUTS) measured by questionnaire(baseline and 6-12 months)
- Drinking behaviour measured by drinking and voiding charts(Baseline and 6-12 months)
- Constipation/fecal incontinence measured by ROME III criteria(Baseline and 6-12 months)
- voiding variables and pelvic floor activity during micturition measured by uroflow/EMG(Baseline and 3-6-12 months)