Applicability of Uroflowmetry in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017415
• Other study ID #: BC-09774
• Status: Completed
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosis of cerebral palsy

• Dutch or French speaking child and parent

Exclusion Criteria:

• History of urological surgery

Related Conditions & MeSH terms

• Cerebral Palsy
• Lower Urinary Tract Symptoms
• Paralysis

Intervention

Device:
• uroflow measurement
Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie
• Bladder ultrasound
Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of pathological uroflow patterns - Qualitative assessment	Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry	During cross-sectional testing
Primary	Amount of pathological uroflow patterns - Quantitative assessment	Interpretation using Flow index methodology Measured during uroflowmetry	During cross-sectional testing
Primary	Maximal flow	Measured during uroflowmetry Qmax (mililitres/seconds	During cross-sectional testing
Secondary	Influencing factors for uroflow measurement	Functional impairment of the child; hip angle; Vancouver symptom score for dysfunctional elimination syndrome	During cross-sectional testing
Secondary	Voided volume	Measured during uroflowmetry mililitres Percentage of expected bladder capacity	During cross-sectional testing
Secondary	Post void residual urine	Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume	During cross-sectional testing