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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00512174
First received: August 6, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Bladder Substitution
Reconstructed Bladder
Other: BladderScan BVI 3000

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Efficacy and Accuracy of a Portable Ultrasound Scanner for Non-Invasive Bladder Volume Measurement (BladderScan BVI3000) in Patients After Radical Cystectomy and Bladder Reconstruction [ Time Frame: 12 Month ]

Study Start Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512174

Contacts
Contact: Uri Lindner, M.D 972-3-5302701 uri.lindner@sheba.health.gov.il

Locations
Israel
Chaim Sheba Medical Center Recruiting
Ramat - Gan, Israel
Sub-Investigator: Uri Lindner, M.D         
Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 5261
Sub-Investigator: Uri A. Lindner, M.D         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Zohar Dotan, M.D, PhD Chaim Sheba Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00512174     History of Changes
Other Study ID Numbers: SHEBA-07-4629-ZD-CTIL
Study First Received: August 6, 2007
Last Updated: August 6, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Portable Ultrasound Scanner
Non Invasive Bladder Volume Measurement
Radical Cystectomy
Bladder Reconstruction

ClinicalTrials.gov processed this record on July 28, 2014