Back to resultsApplicability of Uroflowmetry in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
uroflow measurement
Bladder ultrasound
Sponsored by
About this trial
This is an interventional screening trial for Cerebral Palsy focused on measuring cerebral palsy, lower urinary tract symptoms, incontinence, uroflow measurement
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cerebral palsy
- Dutch or French speaking child and parent
Exclusion Criteria:
- History of urological surgery
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard toilet chair (hip angle 90°)
Toilet chair with decreased hip angle
Arm Description
uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.
uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.
Outcomes
Primary Outcome Measures
Amount of pathological uroflow patterns - Qualitative assessment
Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry
Amount of pathological uroflow patterns - Quantitative assessment
Interpretation using Flow index methodology Measured during uroflowmetry
Maximal flow
Measured during uroflowmetry Qmax (mililitres/seconds
Secondary Outcome Measures
Influencing factors for uroflow measurement
Functional impairment of the child
hip angle
Vancouver symptom score for dysfunctional elimination syndrome
Voided volume
Measured during uroflowmetry mililitres Percentage of expected bladder capacity
Post void residual urine
Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume
Full Information
NCT ID
NCT05017415
First Posted
August 16, 2021
Last Updated
July 28, 2023
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05017415
Brief Title
Applicability of Uroflowmetry in Children With Cerebral Palsy
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Lower Urinary Tract Symptoms
Keywords
cerebral palsy, lower urinary tract symptoms, incontinence, uroflow measurement
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard toilet chair (hip angle 90°)
Arm Type
Experimental
Arm Description
uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.
Arm Title
Toilet chair with decreased hip angle
Arm Type
Experimental
Arm Description
uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.
Intervention Type
Device
Intervention Name(s)
uroflow measurement
Other Intervention Name(s)
uroflowmetry
Intervention Description
Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie
Intervention Type
Device
Intervention Name(s)
Bladder ultrasound
Other Intervention Name(s)
US
Intervention Description
Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700
Primary Outcome Measure Information:
Title
Amount of pathological uroflow patterns - Qualitative assessment
Description
Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry
Time Frame
During cross-sectional testing
Title
Amount of pathological uroflow patterns - Quantitative assessment
Description
Interpretation using Flow index methodology Measured during uroflowmetry
Time Frame
During cross-sectional testing
Title
Maximal flow
Description
Measured during uroflowmetry Qmax (mililitres/seconds
Time Frame
During cross-sectional testing
Secondary Outcome Measure Information:
Title
Influencing factors for uroflow measurement
Description
Functional impairment of the child
hip angle
Vancouver symptom score for dysfunctional elimination syndrome
Time Frame
During cross-sectional testing
Title
Voided volume
Description
Measured during uroflowmetry mililitres Percentage of expected bladder capacity
Time Frame
During cross-sectional testing
Title
Post void residual urine
Description
Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume
Time Frame
During cross-sectional testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cerebral palsy
Dutch or French speaking child and parent
Exclusion Criteria:
History of urological surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bieke Samijn, dr.
Organizational Affiliation
Ghent University Hospital/Ghent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
Flanders
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Applicability of Uroflowmetry in Children With Cerebral Palsy
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