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The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study

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ClinicalTrials.gov Identifier: NCT04010591
Recruitment Status : Enrolling by invitation
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Purpose To measure the impedance of the bladder during the urodynamic study to see if changes in the impedance value occur as the bladder volume changes in pediatric patients aged 5-12 years along with its leg time.

In addition, during the urodynamics test, the heart rate is measured at the same time to confirm the pulse change due to the filling of the bladder.

-Background of the study (Method of identifying urinary bladder using impedance) In order to overcome the limitation of the method of checking the urinary volume in the bladder using ultrasound, the measurement of the impedance in the bladder is proposed as an alternative. Impedance measurement is non-invasive, very low cost, easy to measure and has a great advantage that it can be continuously measured in everyday life. In fact, early studies suggest that impedance measurement in the bladder is helpful in identifying urinary bladder capacity.

On the other hand, there are two disadvantages to the urinary bladder identification method using impedance. One is the relative aspect that the impedance value changes according to the patient, and the other is the time lag time from the measurement point to the point when the impedance change appears.

  • In order to overcome this problem of impedance-based urinary bladder identification method, we measured impedance change according to real-time change of urinary volume in bladder during urodynamic study.
  • Background of the Invention (Pulse changes due to changes in urinary volume in bladder) It is known that when the urine enters the urinary bladder, the autonomic nervous system detects and regulates the heart rhythm, and the change of heart rate has not been reported in pediatric patients.

Condition or disease Intervention/treatment
Voiding Dysfunction Device: impedance measurement during urodynamic study

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Study Type : Observational
Estimated Enrollment : 33 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study - Prospective Study
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
UDS group
All enrolled patients with urodynamic study
Device: impedance measurement during urodynamic study
Impedance information is measured through the belt in the abdomen of the subject. The urodynamic test is performed from the state in which the urine of the bladder is completely emptied to the state of the bladder until the state becomes full, so the impedance measurement is measured from the state where the urine of the bladder is completely emptied to the state of the bladder until the state becomes full.




Primary Outcome Measures :
  1. Bladder Impedance [ Time Frame: Measure the baseline before starting the inspection. ]
    This study was a prospective observational study of 33 patients. Impedance before the bladder filling will be measured.

  2. Bladder Impedance [ Time Frame: Measure up to 5 minutes after of the inspection. ]
    This study was a prospective observational study of 33 patients. Impedance after the bladder filling will be measured.

  3. Bladder pulses [ Time Frame: Measure the baseline before starting the inspection. ]
    This study was a prospective observational study of 33 patients. Pulses before the bladder filling will be measured.

  4. Bladder pulses [ Time Frame: Measure up to 5 minutes after of the inspection. ]
    This study was a prospective observational study of 33 patients. Pulses after the bladder filling will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • 1. Children aged 5-12 years
  • 2. Children in whom urodynamic evaluation is required due to voiding dysfunction
  • 3. Children who agreed to participate in clinical trials

Exclusion Criteria:

  • 1. If there is a previous history of bladder surgery
  • 2. If there is a scar on the upper part of the pubic bone

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): NCT04010591


Locations
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Korea, Republic of
Department of Urology, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04010591    
Other Study ID Numbers: 4-2018-0500
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Pediatric patients
Voiding Dysfunction
urodynamic study