Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy

Urinary Incontinence Clinical Trial

Official title:

Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368262
• Other study ID #: 2011/766.2
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: January 3, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cerebral Palsy
• Enuresis
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital, Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors	Identification of predictive factors for incontinence in children with and without CP.	Cross-sectional	No