Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy

January 3, 2017 updated by: University Hospital, Ghent
This study evaluates (risk)factors influencing (in)continence in children with and without a brain injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital, Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with CP: Cerebral palsy Reference Centre (Ghent university hospital) Incontinent children with normal development: Urology department (Ghent university hospital) continent children with normal development: community sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: 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

Procedure: Uroflowmetry, pelvic floor EMG and bladderscan
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.
Other: 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

Procedure: Uroflowmetry, pelvic floor EMG and bladderscan
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.
Other: 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

Procedure: Uroflowmetry, pelvic floor EMG and bladderscan
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.
Other: 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

Procedure: Uroflowmetry, pelvic floor EMG and bladderscan
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
Identification of predictive factors for incontinence in children with and without CP.
Cross-sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Erik Van Laecke, PhD MD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/766.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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