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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

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, we are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)

Condition or disease Intervention/treatment Phase
Enuresis Biological: Combining electromyography with uroflowmetry (group A) Biological: Uroflowmetry(Group B) Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
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
Official Title: A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : September 30, 2018

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399877


Contacts
Contact: Yong Seung Lee, MD 82-2-2228-2310 asforthelord@yuhs.ac

Locations
Korea, Republic of
Department of Urology, Recruiting
Seoul, Korea, Republic of, 03722
Contact: Yong Seung Lee, MD    82-2-2228-2310    asforthelord@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03399877     History of Changes
Other Study ID Numbers: 4-2017-0842
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders