Micturition Reeducation in Children With Cerebral Palsy

Study Overview
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Brief Summary
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This study evaluates the effectiveness of a voiding reeducation program as treatment for incontinence in children with a brain injury.

Detailed Description
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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.

Official Title
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Micturition Reeducation in Children With Cerebral Palsy

Conditions
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Daytime Urinary Incontinence

Intervention / Treatment
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* Other: urotherapy with or without pharmacotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with CP - Therapy<br>Children receive incontinence treatment during one year, after which a follow-up period of 6 months will be applied. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy | Other: urotherapy with or without pharmacotherapy<br>* Individualized<br>|
| No Intervention: Children with CP - Control<br>Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months. | |
| Active Comparator: Children without CP<br>Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy | Other: urotherapy with or without pharmacotherapy<br>* Individualized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective report of change in urinary incontinence measured by questionnaire |  | Baseline and 3-6-12 months + follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Uroflow and pelvic floor EMG + postmictional residue | Baseline and 3-6-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary incontinence, cerebral palsy, urotherapy, child