A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Yonsei University

Status: Unknown

Conditions: Enuresis

Treatments: Biological: Combining electromyography with uroflowmetry (group A); Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C); Biological: Uroflowmetry(Group B)

Study type: Interventional

Funder types: Other

Identifiers

NCT03399877

4-2017-0842

Details and patient eligibility

About

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)

Enrollment: 51 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

Combining electromygraphy with uroflowmetry

Active Comparator group

Description:

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

Treatment:

Biological: Combining electromyography with uroflowmetry (group A)

Uroflowmetry

Active Comparator group

Description:

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

Treatment:

Biological: Uroflowmetry(Group B)

Uroflowmetry-Combining electromygraphy with uroflowmetry

Experimental group

Description:

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

Treatment:

Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)