Clinical trial NCT04543552: A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
Official title: A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder
Detrusor Underactivity
Detrusor Overactivity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are scheduled to undergo urodynamic studies due to suspected changes in the bladder function or shape.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Scanned bladder volume
timeFrame: Immediately after procedure (urodynamics studies)
measure: Estimated Post Void Residue
timeFrame: Immediately after procedure (urodynamics studies)
measure: Drainage volume
timeFrame: Immediately after procedure (urodynamics studies)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kwanjin Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: