Micturition Reeducation in Children With Cerebral Palsy

Ghent University Hospital (UZ)

Status: Completed

Conditions: Daytime Urinary Incontinence

Treatments: Other: urotherapy with or without pharmacotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02364063

2011/766.1

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Children with CP - Therapy

Experimental group

Description:

Children receive incontinence treatment during one year, after which a follow-up period of 6 months will be applied. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy

Treatment:

Other: urotherapy with or without pharmacotherapy

Children with CP - Control

No Intervention group

Description:

Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months.

Children without CP

Active Comparator group

Description:

Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy

Treatment:

Other: urotherapy with or without pharmacotherapy