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Micturition Reeducation in Children With Cerebral Palsy

Primary Purpose

Daytime Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
urotherapy with or without pharmacotherapy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Daytime Urinary Incontinence focused on measuring Urinary incontinence, cerebral palsy, urotherapy, child

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Children with CP - Therapy

Children with CP - Control

Children without CP

Arm Description

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

Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months.

Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy

Outcomes

Primary Outcome Measures

Subjective report of change in urinary incontinence measured by questionnaire

Secondary Outcome Measures

Lower urinary tract symptoms (LUTS) measured by questionnaire
Drinking behaviour measured by drinking and voiding charts
Constipation/fecal incontinence measured by ROME III criteria
voiding variables and pelvic floor activity during micturition measured by uroflow/EMG
Uroflow and pelvic floor EMG + postmictional residue

Full Information

First Posted
February 9, 2015
Last Updated
January 3, 2017
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT02364063
Brief Title
Micturition Reeducation in Children With Cerebral Palsy
Official Title
Micturition Reeducation in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Daytime Urinary Incontinence
Keywords
Urinary incontinence, cerebral palsy, urotherapy, child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with CP - Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Children with CP - Control
Arm Type
No Intervention
Arm Description
Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months.
Arm Title
Children without CP
Arm Type
Active Comparator
Arm Description
Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy
Intervention Type
Other
Intervention Name(s)
urotherapy with or without pharmacotherapy
Intervention Description
Individualized
Primary Outcome Measure Information:
Title
Subjective report of change in urinary incontinence measured by questionnaire
Time Frame
Baseline and 3-6-12 months + follow-up
Secondary Outcome Measure Information:
Title
Lower urinary tract symptoms (LUTS) measured by questionnaire
Time Frame
baseline and 6-12 months
Title
Drinking behaviour measured by drinking and voiding charts
Time Frame
Baseline and 6-12 months
Title
Constipation/fecal incontinence measured by ROME III criteria
Time Frame
Baseline and 6-12 months
Title
voiding variables and pelvic floor activity during micturition measured by uroflow/EMG
Description
Uroflow and pelvic floor EMG + postmictional residue
Time Frame
Baseline and 3-6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Van Laecke, PhD MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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Micturition Reeducation in Children With Cerebral Palsy

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