A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

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)

Study Overview

• Status: Unknown
• Conditions: Enuresis
• Intervention / Treatment: Biological: Combining electromyography with uroflowmetry (group A); Biological: Uroflowmetry(Group B); Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Urology,
    • Contact: Yong Seung Lee, MD; Phone Number: 82-2-2228-2310; Email: asforthelord@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One day
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)	One day
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.	One day

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urination Disorders; Elimination Disorders; Enuresis
• Other Study ID Numbers: 4-2017-0842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No