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

Completed

• Conditions: Lower Urinary Tract Symptoms; Urologic Diseases
• Interventions: Diagnostic Test: Uroflow/EMG; Diagnostic Test: Uroflow; Diagnostic Test: US

• Registration Number: NCT03339609
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2017-11
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-09
• Last Update Submitted: 2017-11-09
• Study First Posted: 2017-11-13
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immediate uroflow/EMG testing	Uroflow/EMG	Participants performed two direct repetitions of uroflowmetry in combination with EMG.
uroflow measurement beforehand	US	Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG.
uroflow measurement beforehand	Uroflow	Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG.
uroflow measurement beforehand	Uroflow/EMG	Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG.
Immediate uroflow/EMG testing	US	Participants performed two direct repetitions of uroflowmetry in combination with EMG.

Primary Outcome Measures

Name	Time	Method
Uroflow curve pattern - Clinical assessment	2017	Interpretation by pediatric urologist
Uroflow curve pattern - Mathematical assessment	2017	Interpretation using Flow index methodology

Secondary Outcome Measures

Name	Time	Method
voided volume	2017	millilitres
Maximal flow	2017	Qmax (millilitres/seconds)
post-void residual urine	2017	millilitres
voiding time	2017	seconds

Trial Locations

Locations (1)

University Hospital; 🇧🇪 Ghent, Belgium