Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children

Micturition Reeductation in Children With Cerebral Palsy: Uroflow/EMG Measurement in Healthy Children

Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is based on the inexpensiveness, time efficiency, comfort of the patient, etc. However, it is stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate diagnosis. In regard to this, the International Continence Society indicated that the addition of pelvic floor electromyography might increase the accuracy of this assessment. Despite this recommendation, uroflowmetry in combination with electromyography has not been conducted in a healthy population.

The initial objective of this study was to examine whether adding electromyography to standard uroflowmetry in a healthy paediatric population would change the representation of parameters, especially of voiding patterns. In addition, the influence of several factors on uroflow parameters was analysed to complement current literature.

Study Overview

• Status: Completed
• Conditions: Urologic Diseases; Lower Urinary Tract Symptoms
• Intervention / Treatment: Diagnostic test: Uroflow/EMG; Diagnostic test: US; Diagnostic test: Uroflow

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

continent children with normal development: community sample

Description

Inclusion Criteria:

• Normal development

Exclusion Criteria:

• (Recurrent) urinary tract infections
• LUTS which interfered with daily life
• Fecal incontinence
• History of genitourinary or renal surgery
• Medication for incontinence during the last 3 months
• Pelvic reeducation during the last 6 months
• Neurologic problems influencing continence

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immediate uroflow/EMG testing; Participants performed two direct repetitions of uroflowmetry in combination with EMG.	Diagnostic test: Uroflow/EMG; Uroflow measurement with superficial EMG testing of the pelvic floor; Diagnostic test: US; Ultrasound of post void residual urine
uroflow measurement beforehand; Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG.	Diagnostic test: Uroflow/EMG; Uroflow measurement with superficial EMG testing of the pelvic floor; Diagnostic test: US; Ultrasound of post void residual urine; Diagnostic test: Uroflow; Isolated uroflow measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uroflow curve pattern - Clinical assessment	Interpretation by pediatric urologist	2017
Uroflow curve pattern - Mathematical assessment	Interpretation using Flow index methodology	2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal flow	Qmax (millilitres/seconds)	2017
post-void residual urine	millilitres	2017
voiding time	seconds	2017
voided volume	millilitres	2017

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms; Urologic Diseases
• Other Study ID Numbers: 2011/766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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