Cerebral PalsyNCT05017415
Applicability of Uroflowmetry in Children with Cerebral Palsy
A study testing uroflow measurement and Bladder ultrasound in people with Cerebral Palsy and Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy, Lower Urinary Tract Symptoms
- What is being tested?
- uroflow measurement and Bladder ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Oct 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of cerebral palsy
- Dutch or French speaking child and parent
Who cannot join
- History of urological surgery
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Cerebral Palsy, Lower Urinary Tract Symptoms
- Being tested
- uroflow measurement, Bladder ultrasound
- Keywords
- cerebral palsy, lower urinary tract symptoms, incontinence, uroflow measurement
- Medical subject headings
- Cerebral Palsy, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uroflow measurementDevice
Also called uroflowmetry
Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie
Bladder ultrasoundDevice
Also called US
Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700
| Study group | Role | What they receive |
|---|---|---|
| Standard toilet chair (hip angle 90°) | Experimental | uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair. Receives: Device: uroflow measurement; Device: Bladder ultrasound |
| Toilet chair with decreased hip angle | Experimental | uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle. Receives: Device: uroflow measurement; Device: Bladder ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of pathological uroflow patterns - Qualitative assessment
Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry
Measured: During cross-sectional testing
Amount of pathological uroflow patterns - Quantitative assessment
Interpretation using Flow index methodology Measured during uroflowmetry
Measured: During cross-sectional testing
Maximal flow
Measured during uroflowmetry Qmax (mililitres/seconds
Measured: During cross-sectional testing
Secondary outcomes (3)
Influencing factors for uroflow measurement
- Functional impairment of the child
- hip angle
- Vancouver symptom score for dysfunctional elimination syndrome
Measured: During cross-sectional testing
Voided volume
Measured during uroflowmetry mililitres Percentage of expected bladder capacity
Measured: During cross-sectional testing
Post void residual urine
Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume
Measured: During cross-sectional testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start14 Oct 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Bieke Samijn, dr., Principal investigator, Ghent University Hospital/Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017415
- Sponsor's protocol ID
- BC-9774
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05017415
- Acronym / sponsor ID
- BC-9774
- Conditions
- Cerebral Palsy, Lower Urinary Tract Symptoms
- Keywords
- cerebral palsy, lower urinary tract symptoms, incontinence, uroflow measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Children will be randomised in two groups, with evaluation with a standard toilet seat or a toilet seat with decreased hip angle.
| Arm | Type | Receives |
|---|---|---|
| Standard toilet chair (hip angle 90°) | Experimental | Device: uroflow measurement, Device: Bladder ultrasounduroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair. |
| Toilet chair with decreased hip angle | Experimental | Device: uroflow measurement, Device: Bladder ultrasounduroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of cerebral palsy
- Dutch or French speaking child and parent
Key exclusion criteria (1 listed)
- History of urological surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uroflow measurementAlso: uroflowmetryNon-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie | Device | Standard toilet chair (hip angle 90°), Toilet chair with decreased hip angle |
| Bladder ultrasoundAlso: USUltrasound of post void residual urine bladderscan CUBEscan BioCon 700 | Device | Standard toilet chair (hip angle 90°), Toilet chair with decreased hip angle |
Primary outcome
Amount of pathological uroflow patterns - Qualitative assessment
Time frame: During cross-sectional testing
Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry
Amount of pathological uroflow patterns - Quantitative assessment
Time frame: During cross-sectional testing
Interpretation using Flow index methodology Measured during uroflowmetry
Maximal flow
Time frame: During cross-sectional testing
Measured during uroflowmetry Qmax (mililitres/seconds
3 secondary outcomes
Influencing factors for uroflow measurement
Time frame: During cross-sectional testing
Voided volume
Time frame: During cross-sectional testing
Post void residual urine
Time frame: During cross-sectional testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bieke Samijn, dr. principal investigator
Ghent University Hospital/Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uroflow measurement and Bladder ultrasound in people with Cerebral Palsy and Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of pathological uroflow patterns - Qualitative assessment (time frame: During cross-sectional testing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.