Clinical Trial: Micturition Reeducation in Children With Cerebral Palsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Micturition Reeducation in Children With Cerebral Palsy

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

Detailed Summary:

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.


Sponsor: University Hospital, Ghent

Current Primary Outcome: Subjective report of change in urinary incontinence measured by questionnaire [ Time Frame: Baseline and 3-6-12 months + follow-up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Lower urinary tract symptoms (LUTS) measured by questionnaire [ Time Frame: baseline and 6-12 months ]
  • Drinking behaviour measured by drinking and voiding charts [ Time Frame: Baseline and 6-12 months ]
  • Constipation/fecal incontinence measured by ROME III criteria [ Time Frame: Baseline and 6-12 months ]
  • voiding variables and pelvic floor activity during micturition measured by uroflow/EMG [ Time Frame: Baseline and 3-6-12 months ]
    Uroflow and pelvic floor EMG + postmictional residue


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: February 9, 2015
Date Started: September 2014
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017