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A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Primary Purpose

Enuresis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Combining electromyography with uroflowmetry (group A)
Uroflowmetry(Group B)
Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Enuresis

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Urology,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Combining electromygraphy with uroflowmetry

Uroflowmetry

Uroflowmetry-Combining electromygraphy with uroflowmetry

Arm Description

Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography

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

Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography.

Outcomes

Primary Outcome Measures

maximum flow rate(Qmax=cc/s)
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.

Secondary Outcome Measures

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.
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)
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.

Full Information

First Posted
December 22, 2017
Last Updated
January 14, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03399877
Brief Title
A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
Official Title
A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enuresis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combining electromygraphy with uroflowmetry
Arm Type
Active Comparator
Arm Description
Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography
Arm Title
Uroflowmetry
Arm Type
Active Comparator
Arm Description
Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely.
Arm Title
Uroflowmetry-Combining electromygraphy with uroflowmetry
Arm Type
Experimental
Arm Description
Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography.
Intervention Type
Biological
Intervention Name(s)
Combining electromyography with uroflowmetry (group A)
Intervention Description
Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.
Intervention Type
Biological
Intervention Name(s)
Uroflowmetry(Group B)
Intervention Description
Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.
Intervention Type
Biological
Intervention Name(s)
Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
Intervention Description
Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
Primary Outcome Measure Information:
Title
maximum flow rate(Qmax=cc/s)
Description
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
Time Frame
One day
Secondary Outcome Measure Information:
Title
Uroflow curve pattern
Description
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
Title
post void residual
Description
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
Title
synergy or dyssynergy between the bladder and the pelvic floor.
Description
synergy or dyssynergy between the bladder and the pelvic floor is abstained by combining electromyography with uroflowmetry.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Seung Lee, MD
Phone
82-2-2228-2310
Email
asforthelord@yuhs.ac
Facility Information:
Facility Name
Department of Urology,
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Seung Lee, MD
Phone
82-2-2228-2310
Email
asforthelord@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

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