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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lower Urinary Tract Symptoms, Urologic Diseases

Intervention / Treatment
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* Diagnostic Test: Uroflow
* Diagnostic Test: Uroflow/EMG
* Diagnostic Test: US


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immediate uroflow/EMG testing<br>Participants performed two direct repetitions of uroflowmetry in combination with EMG. | Diagnostic Test: Uroflow/EMG<br>* Uroflow measurement with superficial EMG testing of the pelvic floor<br>Diagnostic Test: US<br>* Ultrasound of post void residual urine<br>|
| uroflow measurement beforehand<br>Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG. | Diagnostic Test: Uroflow<br>* Isolated uroflow measurement<br>Diagnostic Test: Uroflow/EMG<br>* Uroflow measurement with superficial EMG testing of the pelvic floor<br>Diagnostic Test: US<br>* Ultrasound of post void residual urine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflow curve pattern - Clinical assessment | Interpretation by pediatric urologist | 2017 | 
| Uroflow curve pattern - Mathematical assessment | Interpretation using Flow index methodology | 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal flow | Qmax (millilitres/seconds) | 2017 | 
| post-void residual urine | millilitres | 2017 | 
| voiding time | seconds | 2017 | 
| voided volume | millilitres | 2017 |