Clinical trial NCT02364063: Micturition Reeducation in Children With Cerebral Palsy
Official title: Micturition Reeducation in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Daytime Urinary Incontinence
Keywords: Urinary incontinence
cerebral palsy
urotherapy
child
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective report of change in urinary incontinence measured by questionnaire
timeFrame: Baseline and 3-6-12 months + follow-up
Secondary outcomes:
measure: Lower urinary tract symptoms (LUTS) measured by questionnaire
timeFrame: baseline and 6-12 months
measure: Drinking behaviour measured by drinking and voiding charts
timeFrame: Baseline and 6-12 months
measure: Constipation/fecal incontinence measured by ROME III criteria
timeFrame: Baseline and 6-12 months
measure: voiding variables and pelvic floor activity during micturition measured by uroflow/EMG
timeFrame: Baseline and 3-6-12 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Erik Van Laecke, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: