A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

NCT03399877 | Unknown DMC

• 1 other identifier: 4-2017-0842
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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)

Conditions

Enuresis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Uroflow curve pattern

  One day

• post void residual

  One day

• synergy or dyssynergy between the bladder and the pelvic floor.

  One day

Study Arms (3)

Combining electromygraphy with uroflowmetry

ACTIVE COMPARATOR

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

Biological: Combining electromyography with uroflowmetry (group A)

Uroflowmetry

ACTIVE COMPARATOR

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

Biological: Uroflowmetry(Group B)

Uroflowmetry-Combining electromygraphy with uroflowmetry

EXPERIMENTAL

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

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

Interventions

Combining electromyography with uroflowmetry (group A) BIOLOGICAL

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

Combining electromygraphy with uroflowmetry

Uroflowmetry(Group B) BIOLOGICAL

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

Uroflowmetry

Uroflowmetry-Combining electromyography with uroflowmetry (Group C) BIOLOGICAL

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

Uroflowmetry-Combining electromygraphy with uroflowmetry

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) children aged 5 to 11.9 who visit pediatric urology department for enuresis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Urology,

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Central Study Contacts

Yong Seung Lee, MD

CONTACT

82-2-2228-2310; asforthelord@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 17, 2018
• Study Start: December 4, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)