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NCT Number: NCT04010591

The Measurement of Bladder Impedance and Heart Rate During Urodynamic 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.

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Key information

Conditions

Voiding Dysfunction

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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