Applicability of Uroflowmetry in Children With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Cerebral Palsy
• Intervention / Treatment: Device: uroflow measurement; Device: Bladder ultrasound

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Ghent, Flanders, Belgium, 9000
      • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• History of urological surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard toilet chair (hip angle 90°); uroflow measurement with subsequent post void residual measurement, conducted on a standard toilet chair.	Device: uroflow measurement; Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie; Other Names: uroflowmetry; Device: Bladder ultrasound; Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700; Other Names: US
Experimental: Toilet chair with decreased hip angle; uroflow measurement with subsequent post void residual measurement, conducted on a toilet chair with decreased hip angle.	Device: uroflow measurement; Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie; Other Names: uroflowmetry; Device: Bladder ultrasound; Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700; Other Names: US

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Bieke Samijn, dr., Ghent University Hospital/Ghent University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cerebral palsy; incontinence; lower urinary tract symptoms; uroflow measurement
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urological Manifestations; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Lower Urinary Tract Symptoms; Paralysis
• Other Study ID Numbers: BC-09774

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No