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
1 other identifier
observational
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedNovember 13, 2017
November 1, 2017
2.7 years
November 6, 2017
November 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Uroflow curve pattern - Clinical assessment
Interpretation by pediatric urologist
2017
Uroflow curve pattern - Mathematical assessment
Interpretation using Flow index methodology
2017
Secondary Outcomes (4)
Maximal flow
2017
post-void residual urine
2017
voiding time
2017
voided volume
2017
Study Arms (2)
Immediate uroflow/EMG testing
Participants performed two direct repetitions of uroflowmetry in combination with EMG.
uroflow measurement beforehand
Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG.
Interventions
Uroflow measurement with superficial EMG testing of the pelvic floor
Ultrasound of post void residual urine
Eligibility Criteria
continent children with normal development: community sample
You may qualify if:
- Normal development
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- University Ghentcollaborator
Study Sites (1)
University Hospital
Ghent, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2017
First Posted
November 13, 2017
Study Start
September 1, 2014
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
November 13, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share