Enuresis
Conditions
Brief summary
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)
Interventions
BIOLOGICALCombining electromyography with uroflowmetry (group A)
Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.
BIOLOGICALUroflowmetry(Group B)
Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.
BIOLOGICALUroflowmetry-Combining electromyography with uroflowmetry (Group C)
Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1\) children aged 5 to 11.9 who visit pediatric urology department for enuresis.
Exclusion criteria
1. If children have experience of performing uroflowmetry or uroflowmetry-electromyography. 2. If children do not cooperate on performing the test 3. If enuresis is caused by neurological or anatomical problem.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum flow rate(Qmax=cc/s) | One day | The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uroflow curve pattern | One day | 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. |
| post void residual | One day | 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) |
| synergy or dyssynergy between the bladder and the pelvic floor. | One day | synergy or dyssynergy between the bladder and the pelvic floor is abstained by combining electromyography with uroflowmetry. |
Countries
South Korea
Contacts
Primary ContactYong Seung Lee, MD
Outcome results
None listed