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OpenTrials
Completed

NCT Number: NCT03339609

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uroflow

Diagnostic Test

Isolated uroflow measurement

Uroflow/EMG

Diagnostic Test

Uroflow measurement with superficial EMG testing of the pelvic floor

US

Diagnostic Test

Ultrasound of post void residual urine

Primary outcomes

  1. Uroflow curve pattern - Clinical assessment

    Time frame: 2017

    Interpretation by pediatric urologist

  2. Uroflow curve pattern - Mathematical assessment

    Time frame: 2017

    Interpretation using Flow index methodology

Secondary outcomes

  1. Maximal flow

    Time frame: 2017

    Qmax (millilitres/seconds)

  2. post-void residual urine

    Time frame: 2017

    millilitres

  3. voiding time

    Time frame: 2017

    seconds

  4. voided volume

    Time frame: 2017

    millilitres

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2017
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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