A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Enuresis Clinical Trial

Official title:

A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399877
• Other study ID #: 4-2017-0842
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: October 2019

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Yong Seung Lee, MD
• Phone: 82-2-2228-2310
• Email: asforthelord[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis

Intervention

Biological:
• Combining electromyography with uroflowmetry (group A)
Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.
• Uroflowmetry(Group B)
Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.
• Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology,	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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