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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)

Interventions

  • Other: BladderScan BVI 3000

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Overall Official(s)
    • Zohar Dotan, M.D, PhD, Principal Investigator, Chaim Sheba Medical Center
  • Overall Contact(s)
    • Uri Lindner, M.D, 972-3-5302701, uri.lindner@sheba.health.gov.il

References

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.

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