Applicability of Uroflowmetry in Children with Cerebral Palsy

NCT ID: NCT05017415

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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Cerebral Palsy Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard toilet chair (hip angle 90°)

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

Group Type EXPERIMENTAL

uroflow measurement

Intervention Type DEVICE

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

Bladder ultrasound

Intervention Type DEVICE

Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700

Toilet chair with decreased hip angle

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

Group Type EXPERIMENTAL

uroflow measurement

Intervention Type DEVICE

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

Bladder ultrasound

Intervention Type DEVICE

Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700

Interventions

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uroflow measurement

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

Intervention Type DEVICE

Bladder ultrasound

Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700

Intervention Type DEVICE

Other Intervention Names

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uroflowmetry US

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of urological surgery
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bieke Samijn, dr.

Role: PRINCIPAL_INVESTIGATOR

Ghent University Hospital/Ghent University

Locations

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Ghent University Hospital

Ghent, Flanders, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BC-9774

Identifier Type: -

Identifier Source: org_study_id

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