Micturition Reeducation in Children With Cerebral Palsy

Daytime Urinary Incontinence Clinical Trial

Official title:

Micturition Reeducation in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364063
• Other study ID #: 2011/766.1
• Status: Completed
• Phase: N/A
• First received: February 9, 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: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Daytime Urinary Incontinence
• Diurnal Enuresis
• Enuresis
• Urinary Incontinence

Intervention

Other:
• urotherapy with or without pharmacotherapy
Individualized

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	Subjective report of change in urinary incontinence measured by questionnaire		Baseline and 3-6-12 months + follow-up	No
Secondary	Lower urinary tract symptoms (LUTS) measured by questionnaire		baseline and 6-12 months	No
Secondary	Drinking behaviour measured by drinking and voiding charts		Baseline and 6-12 months	No
Secondary	Constipation/fecal incontinence measured by ROME III criteria		Baseline and 6-12 months	No
Secondary	voiding variables and pelvic floor activity during micturition measured by uroflow/EMG	Uroflow and pelvic floor EMG + postmictional residue	Baseline and 3-6-12 months	No