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

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ClinicalTrials.gov Identifier: NCT03339609
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Urologic Diseases Diagnostic Test: Uroflow Diagnostic Test: Uroflow/EMG Diagnostic Test: US

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Micturition Reeductation in Children With Cerebral Palsy: Uroflow/EMG Measurement in Healthy Children
Actual Study Start Date : September 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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
Isolated uroflow measurement

Diagnostic Test: Uroflow/EMG
Uroflow measurement with superficial EMG testing of the pelvic floor

Diagnostic Test: US
Ultrasound of post void residual urine




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
continent children with normal development: community sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339609


Locations
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Belgium
University Hospital
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03339609    
Other Study ID Numbers: 2011/766
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms