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NCT Number: NCT05017415

Applicability of Uroflowmetry in Children with Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Lower Urinary Tract Symptoms Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, Flanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • History of urological surgery

Treatment and study plan

uroflow measurement

Device

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

Other names: uroflowmetry

Bladder ultrasound

Device

Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700

Other names: US

Primary outcomes

  1. Amount of pathological uroflow patterns - Qualitative assessment

    Time frame: During cross-sectional testing

    Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry

  2. Amount of pathological uroflow patterns - Quantitative assessment

    Time frame: During cross-sectional testing

    Interpretation using Flow index methodology Measured during uroflowmetry

  3. Maximal flow

    Time frame: During cross-sectional testing

    Measured during uroflowmetry Qmax (mililitres/seconds

Secondary outcomes

  1. Influencing factors for uroflow measurement

    Time frame: During cross-sectional testing

    • Functional impairment of the child
    • hip angle
    • Vancouver symptom score for dysfunctional elimination syndrome

  2. Voided volume

    Time frame: During cross-sectional testing

    Measured during uroflowmetry mililitres Percentage of expected bladder capacity

  3. Post void residual urine

    Time frame: During cross-sectional testing

    Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2021
Registry last updated
Sep 19, 2024

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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