Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy

NCT ID: NCT02368262

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

Brief Summary

This study evaluates (risk)factors influencing (in)continence in children with and without a brain injury.

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.

Conditions

Urinary Incontinence

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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 and micturition and drinking diaries

Intervention Type: OTHER

Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.

Diaries: 24-hour voiding chart

Uroflowmetry, pelvic floor EMG and bladderscan

Intervention Type: PROCEDURE

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 and micturition and drinking diaries

Intervention Type: OTHER

Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.

Diaries: 24-hour voiding chart

Uroflowmetry, pelvic floor EMG and bladderscan

Intervention Type: PROCEDURE

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 and micturition and drinking diaries

Intervention Type: OTHER

Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.

Diaries: 24-hour voiding chart

Uroflowmetry, pelvic floor EMG and bladderscan

Intervention Type: PROCEDURE

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 and micturition and drinking diaries

Intervention Type: OTHER

Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.

Diaries: 24-hour voiding chart

Uroflowmetry, pelvic floor EMG and bladderscan

Intervention Type: PROCEDURE

Voiding variables, pelvic floor activity during micturition and postmictional residue.

Interventions

Questionnaire and micturition and drinking diaries

Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.

Diaries: 24-hour voiding chart

Intervention Type: OTHER

Uroflowmetry, pelvic floor EMG and bladderscan

Voiding variables, pelvic floor activity during micturition and postmictional residue.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Van Laecke, PhD MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

University Hospital, Ghent

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2011/766.2

Identifier Type: -

Identifier Source: org_study_id