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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339609
• Other study ID #: 2011/766
• Status: Completed
• Phase: N/A
• First received: November 6, 2017
• Last updated: November 9, 2017
• Start date: September 2014
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Urologic Diseases

Intervention

Diagnostic Test:
• Uroflow
Isolated uroflow measurement
• Uroflow/EMG
Uroflow measurement with superficial EMG testing of the pelvic floor
• US
Ultrasound of post void residual urine

Locations

Country	Name	City	State
Belgium	University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uroflow curve pattern - Clinical assessment	Interpretation by pediatric urologist	2017
Primary	Uroflow curve pattern - Mathematical assessment	Interpretation using Flow index methodology	2017
Secondary	Maximal flow	Qmax (millilitres/seconds)	2017
Secondary	post-void residual urine	millilitres	2017
Secondary	voiding time	seconds	2017
Secondary	voided volume	millilitres	2017