A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children

NCT04543552 | Completed

• 1 other identifier: H-1709-045-883
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bladder; Detrusor Underactivity; Detrusor Overactivity

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Bladder Scan

Subjects who are scheduled to undergo urodynamic studies.

Device: Bladder scan

Interventions

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.

Also known as: Bladder Scanner, Biocon-900

Bladder Scan

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Bladder, Underactive; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Kwanjin Park, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: September 10, 2020
• Study Start: November 13, 2017
• Primary Completion: April 29, 2021
• Study Completion: May 1, 2021
• Last Updated: May 12, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)