The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study

NCT04010591 | Completed DMC

• 1 other identifier: 4-2018-0500
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Voiding Dysfunction

Keywords

Pediatric patients; Voiding Dysfunction; urodynamic study

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (1)

UDS group

All enrolled patients with urodynamic study

Device: impedance measurement during urodynamic study

Interventions

impedance measurement during urodynamic study DEVICE

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.

UDS group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Urology, Yonsei University College of Medicine

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: July 8, 2019
• Study Start: July 5, 2018
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)