An observational study in Neurogenic Bladder, Detrusor Underactivity and Detrusor Overactivity, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by Seoul National University Hospital · Observational
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.
189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's enrollment of 34 is below the median of 71 across 57 observational studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who are scheduled to undergo urodynamic studies due to suspected changes in the bladder function or shape.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who are scheduled to undergo urodynamic studies.
Device: Bladder scan
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.
Also known as: Bladder Scanner, Biocon-900
Scanned bladder volume
Measurement of the bladder volume
Time frame: Immediately after procedure (urodynamics studies)
Estimated Post Void Residue
Estimated PVR
Time frame: Immediately after procedure (urodynamics studies)
Drainage volume
Residual urine drained by using a catheter
Time frame: Immediately after procedure (urodynamics studies)
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Apr 2021, 41 months.
Of 26 observational studies under Urinary Bladder, Neurogenic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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