The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study

The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study - Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Voiding Dysfunction
• Intervention / Treatment: Device: impedance measurement during urodynamic study

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Urology, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Impedance	This study was a prospective observational study of 33 patients. Impedance before the bladder filling will be measured.	Measure the baseline before starting the inspection.
Bladder Impedance	This study was a prospective observational study of 33 patients. Impedance after the bladder filling will be measured.	Measure up to 5 minutes after of the inspection.
Bladder pulses	This study was a prospective observational study of 33 patients. Pulses before the bladder filling will be measured.	Measure the baseline before starting the inspection.
Bladder pulses	This study was a prospective observational study of 33 patients. Pulses after the bladder filling will be measured.	Measure up to 5 minutes after of the inspection.

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Actual): July 4, 2019
• Study Completion (Actual): July 4, 2019

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pediatric patients; Voiding Dysfunction; urodynamic study
• Other Study ID Numbers: 4-2018-0500

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
• product manufactured in and exported from the U.S.: No