Overview

This trial is active, not recruiting.

Condition urinary incontinence
Treatments questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor emg and bladderscan
Sponsor University Hospital, Ghent
Start date September 2014
End date September 2016
Trial size 80 participants
Trial identifier NCT02368262, 2011/766.2

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
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
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
Voiding variables, pelvic floor activity during micturition and postmictional residue.
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
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
Voiding variables, pelvic floor activity during micturition and postmictional residue.
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
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
Voiding variables, pelvic floor activity during micturition and postmictional residue.
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
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
Voiding variables, pelvic floor activity during micturition and postmictional residue.

Primary Outcomes

Measure
Risk factors
time frame: Cross-sectional

Eligibility Criteria

Male or female participants from 5 years up to 12 years old.

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

Additional Information

Official title Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
Principal investigator Erik Van Laecke, PhD MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.