Clinical trial NCT00512174: Prospective Trial to Evaluate Efficacy and Accuracy of a Portable Ultrasound Scanner for Non-Invasive Bladder Volume Measurement (BladderScan BVI3000) in Patients After Radical Cystectomy and Bladder Reconstruction
Official title: Prospective Trial to Evaluate Efficacy and Accuracy of a Portable Ultrasound Scanner for Non-Invasive Bladder Volume Measurement (BladderScan BVI3000) in Patients After Radical Cystectomy and Bladder Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Substitution
Reconstructed Bladder
Keywords: Portable Ultrasound Scanner
Non Invasive Bladder Volume Measurement
Radical Cystectomy
Bladder Reconstruction
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-08-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy and Accuracy of a Portable Ultrasound Scanner for Non-Invasive Bladder Volume Measurement (BladderScan BVI3000) in Patients After Radical Cystectomy and Bladder Reconstruction
timeFrame: 12 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat - Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Zohar Dotan, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Byun SS, Kim HH, Lee E, Paick JS, Kamg W, Oh SJ. Accuracy of bladder volume determinations by ultrasonography: are they accurate over entire bladder volume range? Urology. 2003 Oct;62(4):656-60. doi: 10.1016/s0090-4295(03)00559-4.