Clinical trial NCT04010591: The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study
Official title: The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study - Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voiding Dysfunction
Keywords: Pediatric patients
Voiding Dysfunction
urodynamic study
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bladder Impedance
timeFrame: Measure the baseline before starting the inspection.
measure: Bladder Impedance
timeFrame: Measure up to 5 minutes after of the inspection.
measure: Bladder pulses
timeFrame: Measure the baseline before starting the inspection.
measure: Bladder pulses
timeFrame: Measure up to 5 minutes after of the inspection.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Yonsei University College of Medicine
Study officials:
References: