Neurogenic BladderNCT04543552
A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
An observational study of Neurogenic Bladder and Detrusor Underactivity, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, cause urinary tract infection, and traumatic experience. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Neurogenic Bladder, Detrusor Underactivity, Detrusor Overactivity
- What is being tested?
- Bladder scan
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2017to 1 May 2021
- 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 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects who are scheduled to undergo urodynamic studies due to suspected changes in the bladder function or shape.
Who may be able to join
- Under the age of 6 years old.
- Urodynamic study is scheduled to due to suspected changes in the bladder function or shape.
- Those who understand and sign the informed consent form.
Who cannot join
- Subjects with surgical history of the bladder.
- Constant leaking of the urine due to bladder neck contracture.
- Any congenital abnormalities that induce changes in the shape of the bladder.
- Unsuitable to participate in the study at the discretion of the principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, cause urinary tract infection, and traumatic experience. Bladder scan has been introduced as an alternative and non-invasive method to measure urine residual in the bladder.
Read the detailed description
Functional urinary disorders are common as more than 15% of children are diagnosed. During the normal course of urinary tract development, bladder and urinary sphincter develop by 2 to 4 years old, and by five years old, the tract is completely developed. The underdevelopment of the urinary tract may lead to complications of the bladder and kidneys along with social impairment. Therefore, the diagnosis is critical as an early diagnosis can prevent long term complications. To diagnose, newborns undergo basic urinalysis, urine culture examination, blood creatinine analysis, and kidney and bladder ultrasound. If any abnormalities are present at the under the age of five, it is recommended that they are followed up on a regular basis. Also, urodynamic studies should be performed every year along with others for early identification and intervention. Studies have shown that UDS (urodynamic studies) significantly reduce the deterioration of the bladder and kidney and the need for operation such as bladder dilation.
As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, which can cause urinary tract infection. The bladder scanner is an ultrasonic imaging device that has been developed for non-invasive measurement of residual volume in the bladder. The images and measurements are obtained by applying a probe onto the abdomen. It constructs 12 cross-sectional images at 15 degree interval using the reflection signals from urine in the bladder and extracts the position of the bladder wall.
The objective of the study is to assess the validity of existing pediatric algorithms for diagnosing neurogenic bladder and evaluate the accuracy of measuring the post-void residual volume between the ages of 0 to 6 years old.
It hypothesizes that when the portable bladder scanner (Bladder Scanner, Biocon-900) is used in pediatric population between the ages of 0 to 3 years old will show greater difference in infused and scanned volume than 4 to 6 years old.
- Being tested
- Bladder scan
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Bladder, Underactive, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder scanDevice
Also called Bladder Scanner, Biocon-900
Bladder Scanner, or Biocon-900 is an ultrasonic imaging device that has been developed to measure post-void residual volume of the bladder non-invasively. The images and measurements are obtained by applying a probe onto the abdomen (i.e. bladder). As it scans, the scanner constructs 12 cross-sectional images at 15 degree interval using the reflection signals from urine in the bladder and extracts the position of the bladder wall as well. During urodynamic studies, the bladder scan will measure the infused volume in order to assess difference between the infused and scanned volumes.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Scan | Subjects who are scheduled to undergo urodynamic studies. Receives: Device: Bladder scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scanned bladder volume
Measurement of the bladder volume
Measured: Immediately after procedure (urodynamics studies)
Estimated Post Void Residue
Estimated PVR
Measured: Immediately after procedure (urodynamics studies)
Drainage volume
Residual urine drained by using a catheter
Measured: Immediately after procedure (urodynamics studies)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start13 Nov 2017
- Primary completion29 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwanjin Park, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543552
- Sponsor's protocol ID
- H-1709-045-883
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
- ClinicalTrials.gov ID
- NCT04543552
- Acronym / sponsor ID
- H-1709-045-883
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 10 Sep 2020 (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.
As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, cause urinary tract infection, and traumatic experience. Bladder scan has been introduced as an alternative and non-invasive method to measure urine residual in the bladder.
Detailed description
Functional urinary disorders are common as more than 15% of children are diagnosed. During the normal course of urinary tract development, bladder and urinary sphincter develop by 2 to 4 years old, and by five years old, the tract is completely developed. The underdevelopment of the urinary tract may lead to complications of the bladder and kidneys along with social impairment. Therefore, the diagnosis is critical as an early diagnosis can prevent long term complications. To diagnose, newborns undergo basic urinalysis, urine culture examination, blood creatinine analysis, and kidney and bladder ultrasound. If any abnormalities are present at the under the age of five, it is recommended that they are followed up on a regular basis. Also, urodynamic studies should be performed every year along with others for early identification and intervention. Studies have shown that UDS (urodynamic studies) significantly reduce the deterioration of the bladder and kidney and the need for operation such as bladder dilation.
As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, which can cause urinary tract infection. The bladder scanner is an ultrasonic imaging device that has been developed for non-invasive measurement of residual volume in the bladder. The images and measurements are obtained by applying a probe onto the abdomen. It constructs 12 cross-sectional images at 15 degree interval using the reflection signals from urine in the bladder and extracts the position of the bladder wall.
The objective of the study is to assess the validity of existing pediatric algorithms for diagnosing neurogenic bladder and evaluate the accuracy of measuring the post-void residual volume between the ages of 0 to 6 years old.
It hypothesizes that when the portable bladder scanner (Bladder Scanner, Biocon-900) is used in pediatric population between the ages of 0 to 3 years old will show greater difference in infused and scanned volume than 4 to 6 years old.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Scan | – | Device: Bladder scanSubjects who are scheduled to undergo urodynamic studies. |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects who are scheduled to undergo urodynamic studies due to suspected changes in the bladder function or shape.
Key inclusion criteria (3 listed)
- Under the age of 6 years old.
- Urodynamic study is scheduled to due to suspected changes in the bladder function or shape.
- Those who understand and sign the informed consent form.
Key exclusion criteria (4 listed)
- Subjects with surgical history of the bladder.
- Constant leaking of the urine due to bladder neck contracture.
- Any congenital abnormalities that induce changes in the shape of the bladder.
- Unsuitable to participate in the study at the discretion of the principal investigator.
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 |
|---|---|---|
| Bladder scanAlso: Bladder Scanner, Biocon-900Bladder Scanner, or Biocon-900 is an ultrasonic imaging device that has been developed to measure post-void residual volume of the bladder non-invasively. The images and measurements are obtained by applying a probe onto the abdomen (i.e. bladder). As it scans, the scanner constructs 12 cross-sectional images at 15 degree interval using the reflection signals from urine in the bladder and extracts the position of the bladder wall as well. During urodynamic studies, the bladder scan will measure the infused volume in order to assess difference between the infused and scanned volumes. | Device | Bladder Scan |
Primary outcome
Scanned bladder volume
Time frame: Immediately after procedure (urodynamics studies)
Measurement of the bladder volume
Estimated Post Void Residue
Time frame: Immediately after procedure (urodynamics studies)
Estimated PVR
Drainage volume
Time frame: Immediately after procedure (urodynamics studies)
Residual urine drained by using a catheter
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 12 May 2021.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Bladder
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
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.
Kwanjin Park, MD, PhD principal investigator
Seoul National University Hospital
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 Neurogenic Bladder and Detrusor Underactivity, run by Seoul National University Hospital 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 4 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 12 May 2021. 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?
Scanned bladder volume (time frame: Immediately after procedure (urodynamics studies)). The study lists 3 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 12 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.