A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03399877

Collaborator

(none)

Enrollment

Location

Arms

21.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Enuresis	Biological: Combining electromyography with uroflowmetry (group A) Biological: Uroflowmetry(Group B) Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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)

Primary Purpose:

Diagnostic

Official Title:

A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Actual Study Start Date :

Dec 4, 2017

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Combining electromygraphy with uroflowmetry

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 A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.

Active Comparator: Uroflowmetry

Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely.

Biological: Uroflowmetry(Group B)

Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.

Experimental: Uroflowmetry-Combining electromygraphy with uroflowmetry

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 C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology,	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT03399877

Other Study ID Numbers:

4-2017-0842

First Posted:

Jan 17, 2018

Last Update Posted:

Jan 16, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Enuresis

Study Results

No Results Posted as of Jan 16, 2019