A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Not Applicable

• Conditions: Enuresis
• Interventions: Biological: Uroflowmetry(Group B); Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C); Biological: Combining electromyography with uroflowmetry (group A)

• Registration Number: NCT03399877
• Lead Sponsor: Yonsei University

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-04
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. children aged 5 to 11.9 who visit pediatric urology department for enuresis.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Uroflowmetry	Uroflowmetry(Group B)	Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely.
Uroflowmetry-Combining electromygraphy with uroflowmetry	Uroflowmetry-Combining electromyography with uroflowmetry (Group C)	Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography.
Combining electromygraphy with uroflowmetry	Combining electromyography with uroflowmetry (group A)	Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

Department of Urology,; 🇰🇷 Seoul, Korea, Republic of