Overview

This trial is active, not recruiting.

Condition daytime urinary incontinence
Treatment urotherapy with or without pharmacotherapy
Sponsor University Hospital, Ghent
Start date September 2014
End date September 2016
Trial size 40 participants
Trial identifier NCT02364063, 2011/766.1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
urotherapy with or without pharmacotherapy
Individualized
(No Intervention)
Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months.
(Active Comparator)
Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy
urotherapy with or without pharmacotherapy
Individualized

Primary Outcomes

Measure
Subjective report of change in urinary incontinence measured by questionnaire
time frame: Baseline and 3-6-12 months + follow-up

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 5 years up to 12 years old.

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

Additional Information

Official title Micturition Reeducation in Children With Cerebral Palsy
Principal investigator Erik Van Laecke, PhD MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.