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Applicability of Uroflowmetry in Children With Cerebral Palsy

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05017415
Collaborator
University Ghent (Other)
100
Enrollment
1
Location
2
Arms
47.6
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: uroflow measurement
  • Device: Bladder ultrasound
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.Children will be randomised in two groups, with evaluation with a standard toilet seat or a toilet seat with decreased hip angle.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Screening
Official 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)
Actual Study Start Date :
Oct 14, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard toilet chair (hip angle 90°)

uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.

Device: uroflow measurement
Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie
Other Names:
  • uroflowmetry

    • Device: Bladder ultrasound
    Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700
    Other Names:
  • US

    		•
    Experimental: Toilet chair with decreased hip angle

    uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.

    Device: uroflow measurement
    Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie
    Other Names:
  • uroflowmetry

    • Device: Bladder ultrasound
    Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700
    Other Names:
  • US

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Amount of pathological uroflow patterns - Qualitative assessment [During cross-sectional testing]

      Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry

    2. Amount of pathological uroflow patterns - Quantitative assessment [During cross-sectional testing]

      Interpretation using Flow index methodology Measured during uroflowmetry

    3. Maximal flow [During cross-sectional testing]

      Measured during uroflowmetry Qmax (mililitres/seconds

    Secondary Outcome Measures

    1. Influencing factors for uroflow measurement [During cross-sectional testing]

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

    2. Voided volume [During cross-sectional testing]

      Measured during uroflowmetry mililitres Percentage of expected bladder capacity

    3. Post void residual urine [During cross-sectional testing]

      Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of cerebral palsy

    • Dutch or French speaking child and parent

    Exclusion Criteria:
    • History of urological surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ghent University Hospital Ghent Flanders Belgium 9000

    Sponsors and Collaborators

    • University Hospital, Ghent
    • University Ghent

    Investigators

    • Principal Investigator: Bieke Samijn, dr., Ghent University Hospital/Ghent University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Ghent
    ClinicalTrials.gov Identifier:
    NCT05017415
    Other Study ID Numbers:
    • BC-09774
    First Posted:
    Aug 23, 2021
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Ghent
    cerebral palsy
    lower urinary tract symptoms
    incontinence
    uroflow measurement
    Additional relevant MeSH terms:
    Paralysis
    Cerebral Palsy
    Lower Urinary Tract Symptoms

    Study Results

    No Results Posted as of Jan 25, 2022