A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
Condition: Neurogenic Bladder; Detrusor Underactivity; Detrusor Overactivity
MeSH terms: Urinary Bladder, Neurogenic; Hypokinesia; Urinary Bladder, Underactive
Study type: Observational

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.
    

Intervention name(s): Bladder scan
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Bladder Scanner, Biocon-900
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.