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Completed

NCT Number: NCT02364063

Micturition Reeducation in Children With Cerebral Palsy

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

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Key information

Conditions

Daytime Urinary Incontinence Behavior Behavioral Symptoms Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Diurnal Enuresis Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Ghent

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urotherapy with or without pharmacotherapy

Other

Individualized

Primary outcomes

  1. Subjective report of change in urinary incontinence measured by questionnaire

    Time frame: Baseline and 3-6-12 months + follow-up

Secondary outcomes

  1. Lower urinary tract symptoms (LUTS) measured by questionnaire

    Time frame: baseline and 6-12 months

  2. Drinking behaviour measured by drinking and voiding charts

    Time frame: Baseline and 6-12 months

  3. Constipation/fecal incontinence measured by ROME III criteria

    Time frame: Baseline and 6-12 months

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2015
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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