- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368262
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
Study Overview
Status
Conditions
Detailed Description
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: Analyze (risk) factors influencing (in)continence in children with and without CP.
Possible parameters will be registered through questioning, measurement (uroflow combined with pelvic floor EMG and postmictional residue) and retrospective analysis of the patient files. Parameters will be compared between continent and incontinent children with and without CP. This comparison evaluates whether the same therapeutic strategies can be applied in incontinent children with and without CP.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- University Hospital, Ghent
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Daytime urinary incontinence with or without enuresis and/or fecal incontinence (Groups with incontinence)
- No urinary or fecal incontinence (Groups without incontinence)
- Cerebral palsy (Groups with children with CP)
- Normal development (Groups with 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CP- incontinent
Children with CP and daytime incontinence.
Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan.
|
Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q. Diaries: 24-hour voiding chart
Voiding variables, pelvic floor activity during micturition and postmictional residue.
|
|
CP- continent
Children with CP without daytime incontinence.
Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan.
|
Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q. Diaries: 24-hour voiding chart
Voiding variables, pelvic floor activity during micturition and postmictional residue.
|
|
NoDev - incontinent
Children with normal development with daytime incontinence.
Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan.
|
Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q. Diaries: 24-hour voiding chart
Voiding variables, pelvic floor activity during micturition and postmictional residue.
|
|
NoDev - continent
Children with normal development without daytime incontinence.
Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan.
|
Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q. Diaries: 24-hour voiding chart
Voiding variables, pelvic floor activity during micturition and postmictional residue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors
Time Frame: Cross-sectional
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Identification of predictive factors for incontinence in children with and without CP.
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Cross-sectional
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erik Van Laecke, PhD MD, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/766.2
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