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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Scan | Subjects who are scheduled to undergo urodynamic studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder scan | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Scanned bladder volume | Measurement of the bladder volume | Immediately after procedure (urodynamics studies) |
| Estimated Post Void Residue | Estimated PVR | Immediately after procedure (urodynamics studies) |
| Drainage volume | Residual urine drained by using a catheter | Immediately after procedure (urodynamics studies) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are scheduled to undergo urodynamic studies due to suspected changes in the bladder function or shape.
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| Name | Affiliation | Role |
|---|---|---|
| Kwanjin Park, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 7, 2022 | |
| Reset | May 24, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 7, 2022 | May 24, 2022 |
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D000077295 | Urinary Bladder, Underactive |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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|
|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |