Clinical Trials Directory

Trials / Completed

CompletedNCT04010591

The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study

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

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEimpedance measurement during urodynamic studyImpedance 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.

Timeline

Start date
2018-07-05
Primary completion
2019-07-04
Completion
2019-07-04
First posted
2019-07-08
Last updated
2020-10-08

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04010591. Inclusion in this directory is not an endorsement.