Bladder Fibrosis
Conditions
Brief summary
Urinary bladder fibrosis (thickening and scarring) is fairly uncommon in children. Traditionally, the presence of urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic testing. In this study we will use ultrasound scanning and ARFI (acoustic radiation force impulse) wave velocities to potentially identify any urinary bladder wall fibrosis.
Detailed description
Urinary bladder fibrosis (thickening and scarring) is fairly uncommon in children. Traditionally, the presence of urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic testing. We will use ultrasound ARFI (acoustic radiation force impulse)-derived shear wave velocities to potentially identify the presence of urinary bladder wall fibrosis. We hypothesize that shear wave velocities found within the bladder wall will increase with increasing evidence of fibrosis.
Interventions
DEVICEARFI-Derived Shear Wave Velocities
An ultrasound based scan uses ARFI, an acoustic radiation force impulse to estimate shear wave velocities during scanning of the urinary bladder. The research ultrasound scan lasts about 10 to 15 minutes.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or younger 2. Have an order for urodynamic testing from your doctor
Exclusion criteria
1. Adults 2. Unwilling to sign consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shear Wave Velocity, VTQ | Visit 0 | Shear wave velocity VTQ, or Virtual Touch Quantification is a point method for measuring a tissue's stiffness. A stiffness value is obtained from only the area in which a region of interest is placed. |
| Shear Wave Velocity (VITQ) | Visit 0 | Shear Wave Velocity, VITQ, or Virtual Touch Tissue Imaging quantification is a color 2D method for measuring a tissues's stiffness. A color image (elastogram) of stiffness is acquired using this method. Then, one or more regions of interest can be placed in the area of interest on the elastogram. VITQ regions of interest are smaller than those used by VTQ. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| (ARFI)-Derived Shear Wave Velocities This is an new ultrasound-based technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. ARFI can be used to aid in detecting wall thickness and fibrosis in the urinary bladder of pediatric patients.
ARFI-Derived Shear Wave Velocities: This technology uses ultrasound scanning with acoustic radiation force impulse-derived (called ARFI). This technique measures shear wave velocities to obtain and analyze images of the urinary bladder. The research ultrasound scan takes 10-15 minutes to complete. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | (ARFI)-Derived Shear Wave Velocities |
|---|---|
| Age | 4.6 years |
| Age, Categorical <=18 years | 26 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Shear Wave Velocity (VITQ)
Shear Wave Velocity, VITQ, or Virtual Touch Tissue Imaging quantification is a color 2D method for measuring a tissues's stiffness. A color image (elastogram) of stiffness is acquired using this method. Then, one or more regions of interest can be placed in the area of interest on the elastogram. VITQ regions of interest are smaller than those used by VTQ.
Time frame: Visit 0
Population: The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the bladder. The ultrasound scans may be an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| (ARFI)-Derived Shear Wave Velocities | Shear Wave Velocity (VITQ) | 2.37 meters per second | Standard Deviation 0.51 |
Primary
Shear Wave Velocity, VTQ
Shear wave velocity VTQ, or Virtual Touch Quantification is a point method for measuring a tissue's stiffness. A stiffness value is obtained from only the area in which a region of interest is placed.
Time frame: Visit 0
Population: The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the urinary bladder.~The ultrasound scans were investigated as an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| (ARFI)-Derived Shear Wave Velocities | Shear Wave Velocity, VTQ | 1.95 meters per second | Standard Deviation 0.63 |