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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

NCT ID: NCT00512174

Last Updated: 2007-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Substitution Reconstructed Bladder

Study Design

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Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Interventions

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BladderScan BVI 3000

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Zohar Dotan, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

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Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Uri Lindner, M.D

Role: CONTACT

[email protected]
972-3-5302701

References

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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.

Reference Type BACKGROUND
PMID: 14550437 (View on PubMed)

Other Identifiers

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SHEBA-07-4629-ZD-CTIL

Identifier Type: -

Identifier Source: org_study_id