Applicability of Uroflowmetry in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Cerebral Palsy
• Interventions: Device: uroflow measurement; Device: Bladder ultrasound

• Registration Number: NCT05017415
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Study Start: 2021-10-14
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

Exclusion Criteria

• History of urological surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toilet chair with decreased hip angle	uroflow measurement	uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.
Standard toilet chair (hip angle 90°)	uroflow measurement	uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.
Standard toilet chair (hip angle 90°)	Bladder ultrasound	uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.
Toilet chair with decreased hip angle	Bladder ultrasound	uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.

Primary Outcome Measures

Name	Time	Method
Amount of pathological uroflow patterns - Quantitative assessment	During cross-sectional testing	Interpretation using Flow index methodology Measured during uroflowmetry
Maximal flow	During cross-sectional testing	Measured during uroflowmetry Qmax (mililitres/seconds
Amount of pathological uroflow patterns - Qualitative assessment	During cross-sectional testing	Interpretation by pediatric urologist following ICCS classification Measured during uroflowmetry

Secondary Outcome Measures

Name	Time	Method
Influencing factors for uroflow measurement	During cross-sectional testing	* Functional impairment of the child; * hip angle; * Vancouver symptom score for dysfunctional elimination syndrome
Post void residual urine	During cross-sectional testing	Measured with CUBEscan BioCon 700 mililiters Percentage of voided volume
Voided volume	During cross-sectional testing	Measured during uroflowmetry mililitres Percentage of expected bladder capacity

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Flanders, Belgium