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Applicability of Uroflowmetry in Children with Cerebral Palsy

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05017415
Enrollment
56
Registered
2021-08-23
Start date
2021-10-14
Completion date
2023-06-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Lower Urinary Tract Symptoms

Keywords

cerebral palsy, lower urinary tract symptoms, incontinence, uroflow measurement

Brief summary

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

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.

Interventions

DEVICEuroflow measurement

Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie

Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700

Sponsors

University Ghent
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Children will be randomised in two groups, with evaluation with a standard toilet seat or a toilet seat with decreased hip angle.

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of cerebral palsy * Dutch or French speaking child and parent

Exclusion criteria

* History of urological surgery

Design outcomes

Primary

MeasureTime frameDescription
Amount of pathological uroflow patterns - Qualitative assessmentDuring cross-sectional testingInterpretation by pediatric urologist following ICCS classification Measured during uroflowmetry
Amount of pathological uroflow patterns - Quantitative assessmentDuring cross-sectional testingInterpretation using Flow index methodology Measured during uroflowmetry
Maximal flowDuring cross-sectional testingMeasured during uroflowmetry Qmax (mililitres/seconds

Secondary

MeasureTime frameDescription
Influencing factors for uroflow measurementDuring cross-sectional testing* Functional impairment of the child * hip angle * Vancouver symptom score for dysfunctional elimination syndrome
Voided volumeDuring cross-sectional testingMeasured during uroflowmetry mililitres Percentage of expected bladder capacity
Post void residual urineDuring cross-sectional testingMeasured with CUBEscan BioCon 700 mililiters Percentage of voided volume

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026