An interventional study of Combining electromyography with uroflowmetry (group A) and Uroflowmetry(Group B) in Enuresis, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Yonsei University · Not applicable, Interventional, and Diagnostic
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)
846 studies on the registry are indexed under Enuresis; 79 are open to participants now.
This study's planned enrollment of 51 is below the median of 64 across 654 interventional studies indexed under Enuresis.
Browse Enuresis studies →Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
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1) children aged 5 to 11.9 who visit pediatric urology department for enuresis.
Exclusion Criteria:
Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography
Biological: Combining electromyography with uroflowmetry (group A)
Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely.
Biological: Uroflowmetry(Group B)
Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography.
Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
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.
maximum flow rate(Qmax=cc/s)
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
Time frame: One day
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.
Time frame: 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)
Time frame: 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.
Time frame: One day
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2017 (actual). Primary completion is estimated for Oct 2019, 22 months after the start.
Of 262 non-industry interventional studies with no phase under Enuresis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 22 months is above that.
Counting every sponsor, half of 308 studies reached it within 15 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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