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A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

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ClinicalTrials.gov Identifier: NCT03399877
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

December 22, 2017
January 17, 2018
January 17, 2018
December 4, 2017
August 30, 2018   (Final data collection date for primary outcome measure)
maximum flow rate(Qmax=cc/s) [ Time Frame: One day ]
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
Same as current
No Changes Posted
  • Uroflow curve pattern [ Time Frame: One day ]
    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 [ Time Frame: One day ]
    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. [ Time Frame: One day ]
    synergy or dyssynergy between the bladder and the pelvic floor is abstained by combining electromyography with uroflowmetry.
Same as current
Not Provided
Not Provided
 
A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
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, we are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Diagnostic
Enuresis
  • Biological: Combining electromyography with uroflowmetry (group A)
    Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.
  • Biological: Uroflowmetry(Group B)
    Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.
  • Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
    Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
  • Active Comparator: Combining electromygraphy with uroflowmetry
    Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography
    Intervention: Biological: Combining electromyography with uroflowmetry (group A)
  • Active Comparator: Uroflowmetry
    Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely.
    Intervention: Biological: Uroflowmetry(Group B)
  • Experimental: Uroflowmetry-Combining electromygraphy with uroflowmetry
    Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography.
    Intervention: Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
51
Same as current
September 30, 2018
August 30, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 12 Years   (Child)
No
Contact: Yong Seung Lee, MD 82-2-2228-2310 asforthelord@yuhs.ac
Korea, Republic of
 
 
NCT03399877
4-2017-0842
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP