Bladder Substitution, Reconstructed Bladder
Conditions
Keywords
Portable Ultrasound Scanner, Non Invasive Bladder Volume Measurement, Radical Cystectomy, Bladder Reconstruction
Brief summary
Thirty patients who underwent radical cystectomy and bladder substitution and thirty people with native bladders will be enrolled in the study. After meticulous explanations each person will undergo sterile catheterization of the bladder/neobladder with a 14 Fr Foley catheter. After catheterization the bladder will be fully emptied. Randomly assigned volume of sterile saline will be injected to the bladder via the catheter by one sub investigator and the bladder capacity will be measured via a portable ultrasound scanner for non-invasive bladder volume measurement (BladderScan BVI3000) by another sub investigator. The volume injected and the measured results will remain in a closed envelope till the completion of the trial. After each measurement the first sub investigator will completely empty the bladder/neobladder and the process will repeat itself for a total of six measurements for each patient or first mention of discomfort (whichever comes first), after which the bladder will be drained once more and the catheter removed.
Interventions
OTHERBladderScan BVI 3000
Sponsors
Sheba Medical Center
Study design
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Group A: Patients ages 18-75, at least 6 month after radical cystectomy and bladder substituition Group B: Volunteers same age group as group A, with native bladder as control group
Exclusion criteria
Group A: carrying ureteral stent of any kind, inability to catheterize patient due to severe urethral stricture, incarcerated post operative ventral hernia, after mesh repair of POVH, active urinary tract infection, acute bacterial prostatitis. Group B: patients after partial cystectomy, incarcerated post operative ventral hernia, after mesh repair of POVH, active urinary tract infection, acute bacterial prostatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and Accuracy of a Portable Ultrasound Scanner for Non-Invasive Bladder Volume Measurement (BladderScan BVI3000) in Patients After Radical Cystectomy and Bladder Reconstruction | 12 Month |
Countries
Israel
Contacts
Primary ContactUri Lindner, M.D
Outcome results
None listed