Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 5 to 12 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: July 2018
See protocol details

Summary

Principal SponsorYonsei University
Last updated: January 28, 2026
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Study start date: July 5, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleThe Measurement of Bladder Impedance and Heart Rate During Urodynamic Study - Prospective Study
NCT04010591
Principal SponsorYonsei University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
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

2 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Urology, Yonsei University College of Medicine

Seoul, South KoreaOpen Department of Urology, Yonsei University College of Medicine in Google Maps
CompletedOne Study Center
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