Applicability of Uroflowmetry in Children with Cerebral Palsy

NCT05017415 | Completed

• 1 other identifier: BC-9774
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Lower Urinary Tract Symptoms

Keywords

cerebral palsy; lower urinary tract symptoms; incontinence; uroflow measurement

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Influencing factors for uroflow measurement

  During cross-sectional testing

• Voided volume

  During cross-sectional testing

• Post void residual urine

  During cross-sectional testing

Study Arms (2)

Standard toilet chair (hip angle 90°)

EXPERIMENTAL

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

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.

Device: uroflow measurement; Device: Bladder ultrasound

Interventions

uroflow measurement DEVICE

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

Also known as: uroflowmetry

Standard toilet chair (hip angle 90°); Toilet chair with decreased hip angle

Bladder ultrasound DEVICE

Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700

Also known as: US

Standard toilet chair (hip angle 90°); Toilet chair with decreased hip angle

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• History of urological surgery

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bieke Samijn, dr.

  Ghent University Hospital/Ghent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will be randomised in two groups, with evaluation with a standard toilet seat or a toilet seat with decreased hip angle.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: October 14, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)