Applicability of Uroflowmetry in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Until now, the use of invasive urodynamics with use of catheters is still the gold standard for lower urinary tract evaluation in subjects with CP. This suggests a psychological and physical impact of invasive urodynamics in subjects with CP and further demonstrates the need to avoid standard use of invasive urodynamics in children and adults with CP. The current study will evaluate usefulness of uroflowmetry, correlation between uroflowmetry parameters and different lower urinary tract symptoms will be investigated. Secondly, results of uroflowmetry indicating possible vulnerability of the upper urinary tract will be defined.

Detailed Description
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A cross-sectional case-control study comparing children with CP and LUTS and children with CP without LUTS will be conducted with the primary objective to investigate correlation between uroflowmetry parameters and different LUTS. Children will be evaluated with uroflowmetry and subsequent post void residual measurement and the validated vancouver symptom score for dysfunctional elimination syndrome.

Official Title
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What is the Difference in the Applicability of the Uroflowmetry Between Children With Cerebral Palsy (CP) With Lower Urinary Tract Symptoms (LUTS) and Without Lower Urinary Tract Symptoms (LUTS)

Conditions
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Cerebral Palsy, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: uroflow measurement
* Device: Bladder ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cerebral palsy Dutch or French speaking child and parent Exclusion Criteria: History of urological surgery

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children will be randomised in two groups, with evaluation with a standard toilet seat or a toilet seat with decreased hip angle.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard toilet chair (hip angle 90°)<br>uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair. | Device: uroflow measurement<br>* Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie<br>* Other names: uroflowmetry;Device: Bladder ultrasound<br>* Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700<br>* Other names: US;|
| Experimental: Toilet chair with decreased hip angle<br>uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle. | Device: uroflow measurement<br>* Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie<br>* Other names: uroflowmetry;Device: Bladder ultrasound<br>* Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700<br>* Other names: US;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of pathological uroflow patterns - Qualitative assessment | Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry | During cross-sectional testing | 
| Amount of pathological uroflow patterns - Quantitative assessment | Interpretation using Flow index methodology Measured during uroflowmetry | During cross-sectional testing | 
| Maximal flow | Measured during uroflowmetry Qmax (mililitres/seconds | During cross-sectional testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influencing factors for uroflow measurement | Functional impairment of the child hip angle Vancouver symptom score for dysfunctional elimination syndrome | During cross-sectional testing | 
| Voided volume | Measured during uroflowmetry mililitres Percentage of expected bladder capacity | During cross-sectional testing | 
| Post void residual urine | Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume | During cross-sectional testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incontinence, cerebral palsy, lower urinary tract symptoms, uroflow measurement