An interventional study of uroflow measurement and Bladder ultrasound in Cerebral Palsy and Lower Urinary Tract Symptoms, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Screening
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.
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.
750 studies on the registry are indexed under Paralysis; 133 are open to participants now.
This study's enrollment of 56 is above the median of 30 across 537 interventional studies indexed under Paralysis.
Browse Paralysis studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.
Device: uroflow measurement · Device: Bladder ultrasound
uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.
Device: uroflow measurement · Device: Bladder ultrasound
Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie
Also known as: uroflowmetry
Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700
Also known as: US
Amount of pathological uroflow patterns - Qualitative assessment
Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry
Time frame: During cross-sectional testing
Amount of pathological uroflow patterns - Quantitative assessment
Interpretation using Flow index methodology Measured during uroflowmetry
Time frame: During cross-sectional testing
Maximal flow
Measured during uroflowmetry Qmax (mililitres/seconds
Time frame: During cross-sectional testing
Influencing factors for uroflow measurement
* Functional impairment of the child * hip angle * Vancouver symptom score for dysfunctional elimination syndrome
Time frame: During cross-sectional testing
Voided volume
Measured during uroflowmetry mililitres Percentage of expected bladder capacity
Time frame: During cross-sectional testing
Post void residual urine
Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume
Time frame: During cross-sectional testing
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent