NCT02368262

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

February 13, 2015

Last Update Submit

January 3, 2017

Conditions

Urinary Incontinence

Keywords

Cerebral PalsyRisk factorsChildurinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Risk factors

    Identification of predictive factors for incontinence in children with and without CP.

    Cross-sectional

Study Arms (4)

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 diariesProcedure: Uroflowmetry, pelvic floor EMG and bladderscan

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 diariesProcedure: Uroflowmetry, pelvic floor EMG and bladderscan

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 diariesProcedure: Uroflowmetry, pelvic floor EMG and bladderscan

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 diariesProcedure: Uroflowmetry, pelvic floor EMG and bladderscan

Interventions

Questionnaire and micturition and drinking diariesOTHER

Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q. Diaries: 24-hour voiding chart

CP- continentCP- incontinentNoDev - continentNoDev - incontinent
Uroflowmetry, pelvic floor EMG and bladderscanPROCEDURE

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

CP- continentCP- incontinentNoDev - continentNoDev - incontinent

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Urinary IncontinenceCerebral Palsy

Interventions

Surveys and QuestionnairesUrination

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Erik Van Laecke, PhD MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 23, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

BE(1)