A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2019-10-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Enuresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Combining electromygraphy with uroflowmetry

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

Group Type ACTIVE_COMPARATOR

Combining electromyography with uroflowmetry (group A)

Intervention Type BIOLOGICAL

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

Uroflowmetry

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

Group Type ACTIVE_COMPARATOR

Uroflowmetry(Group B)

Intervention Type BIOLOGICAL

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

Uroflowmetry-Combining electromygraphy with uroflowmetry

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

Group Type EXPERIMENTAL

Uroflowmetry-Combining electromyography with uroflowmetry (Group C)

Intervention Type BIOLOGICAL

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

Interventions

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Combining electromyography with uroflowmetry (group A)

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

Intervention Type BIOLOGICAL

Uroflowmetry(Group B)

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

Intervention Type BIOLOGICAL

Uroflowmetry-Combining electromyography with uroflowmetry (Group C)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No