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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

Tracking Information
First Submitted Date April 30, 2019
First Posted Date July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date July 5, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study
Official Title The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study - Prospective Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population primary care clinic
Condition Voiding Dysfunction
Intervention 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.
Study Groups/Cohorts UDS group
All enrolled patients with urodynamic study
Intervention: Device: impedance measurement during urodynamic study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 4, 2019)
33
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010591
Other Study ID Numbers 4-2018-0500
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date July 2019