A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Study Overview
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Brief Summary
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Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of pediatric voiding dysfunction. But recently, UF combined with pelvic flow electromyography(EMG) is emphasized and recommended to analyze the separate contributions of the detrusor and bladder outlet and sole UF is discouraged except for the follow-up study after abnormal UF/EMG result(Bauer et al., 2015). However, electrode itself can disturb pelvic floor relaxation and there is no evidence about necessity of consecutive UF/EMG test. Therefore, the investigators are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)

Official Title
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A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Conditions
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Enuresis

Intervention / Treatment
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* Biological: Combining electromyography with uroflowmetry (group A)
* Biological: Uroflowmetry(Group B)
* Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) children aged 5 to 11.9 who visit pediatric urology department for enuresis. Exclusion Criteria: If children have experience of performing uroflowmetry or uroflowmetry-electromyography. If children do not cooperate on performing the test If enuresis is caused by neurological or anatomical problem.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Children who meet the inclusion criteria and no exclusion criteria are assigned to perform one of the three test protocols in order of registration according to a computer gererated randomization list. Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again. Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry. Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combining electromygraphy with uroflowmetry<br>Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography | Biological: Combining electromyography with uroflowmetry (group A)<br>* Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.<br>|
| Active Comparator: Uroflowmetry<br>Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely. | Biological: Uroflowmetry(Group B)<br>* Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.<br>|
| Experimental: Uroflowmetry-Combining electromygraphy with uroflowmetry<br>Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography. | Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)<br>* Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum flow rate(Qmax=cc/s) | The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflow curve pattern | Uroflow curve pattern: There are 5 uroflow curve patterns, bell-shaped, tower-shaped, interrupted-shaped, staccato-shaped and plateau shaped by uroflowmetry. The shape is determined by detrusor contractility and influenced by abdominal straining, coordination with the bladder outlet musculature and any distal anatomic obstruction. | One day | 
| post void residual | post-void residual(cc): ultrasonographic bladder scan machines calculates bladder volume. PVR measurements in neurologically intact children are highly variable. PVR must be obtained immediately after voiding(<5min) | One day | 
| synergy or dyssynergy between the bladder and the pelvic floor. | synergy or dyssynergy between the bladder and the pelvic floor is abstained by combining electromyography with uroflowmetry. | One day |