Micturition Reeducation in Children With Cerebral Palsy

January 3, 2017 updated by: University Hospital, Ghent
This study evaluates the effectiveness of a voiding reeducation program as treatment for incontinence in children with 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: 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with CP - Therapy
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
Individualized
No Intervention: Children with CP - Control
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
Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy
Other: urotherapy with or without pharmacotherapy
Individualized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective report of change in urinary incontinence measured by questionnaire
Time Frame: Baseline and 3-6-12 months + follow-up
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
Time Frame: baseline and 6-12 months
baseline and 6-12 months
Drinking behaviour measured by drinking and voiding charts
Time Frame: Baseline and 6-12 months
Baseline and 6-12 months
Constipation/fecal incontinence measured by ROME III criteria
Time Frame: Baseline and 6-12 months
Baseline and 6-12 months
voiding variables and pelvic floor activity during micturition measured by uroflow/EMG
Time Frame: Baseline and 3-6-12 months
Uroflow and pelvic floor EMG + postmictional residue
Baseline and 3-6-12 months

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 9, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 16, 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

  • 2011/766.1

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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