Voiding DysfunctionNCT04010591
The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study
An observational study of Voiding Dysfunction, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Voiding Dysfunction
- What is being tested?
- impedance measurement during urodynamic study
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2018to 4 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 1. If there is a previous history of bladder surgery
- 2. If there is a scar on the upper part of the pubic bone
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Yonsei University College of Medicine
Seoul
About this study
Official title: The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study - Prospective 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.
Read more
-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
- Voiding Dysfunction
- Being tested
- impedance measurement during urodynamic study
- Keywords
- Pediatric patients, Voiding Dysfunction, urodynamic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impedance measurement during urodynamic studyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| UDS group | All enrolled patients with urodynamic study Receives: Device: impedance measurement during urodynamic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Impedance
This study was a prospective observational study of 33 patients. Impedance before the bladder filling will be measured.
Measured: Measure the baseline before starting the inspection.
Bladder Impedance
This study was a prospective observational study of 33 patients. Impedance after the bladder filling will be measured.
Measured: Measure up to 5 minutes after of the inspection.
Bladder pulses
This study was a prospective observational study of 33 patients. Pulses before the bladder filling will be measured.
Measured: Measure the baseline before starting the inspection.
Bladder pulses
This study was a prospective observational study of 33 patients. Pulses after the bladder filling will be measured.
Measured: Measure up to 5 minutes after of the inspection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start5 Jul 2018
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010591
- Sponsor's protocol ID
- 4-2018-0500
- Status last verified
- Oct 2020
- First submitted
- 30 Apr 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study - Prospective Study
- ClinicalTrials.gov ID
- NCT04010591
- Acronym / sponsor ID
- 4-2018-0500
- Conditions
- Voiding Dysfunction
- Keywords
- Pediatric patients, Voiding Dysfunction, urodynamic study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UDS group | – | Device: impedance measurement during urodynamic studyAll enrolled patients with urodynamic study |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 1. If there is a previous history of bladder surgery
- 2. If there is a scar on the upper part of the pubic bone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impedance 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. | Device | UDS group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voiding Dysfunction, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Impedance (time frame: Measure the baseline before starting the inspection.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.