The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study

Completed

• Conditions: Voiding Dysfunction
• Interventions: Device: impedance measurement during urodynamic study

• Registration Number: NCT04010591
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Study First Submitted: 2019-04-30
• Primary Completion: 2019-07-04
• Study Completion: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UDS group	impedance measurement during urodynamic study	All enrolled patients with urodynamic study

Primary Outcome Measures

Name	Time	Method
Bladder pulses	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.
Bladder Impedance	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.

Trial Locations

Locations (1)

Department of Urology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of