Bladder SubstitutionNCT00512174
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
A study testing BladderScan BVI 3000 in people with Bladder Substitution and Reconstructed Bladder, run by Sheba Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Substitution, Reconstructed Bladder
- What is being tested?
- BladderScan BVI 3000
- How many people
- Not given
- Where
- 2 sitesIsrael
- Study dates
- Aug 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Chaim Sheba Medical Center
Ramat Gan, 5261
Uri A. Lindner, M.D
- Recruiting
Chaim Sheba Medical Center
Ramat Gan
Uri Lindner, M.D
About this study
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.
- Conditions
- Bladder Substitution, Reconstructed Bladder
- Being tested
- BladderScan BVI 3000
- Keywords
- Portable Ultrasound Scanner, Non Invasive Bladder Volume Measurement, Radical Cystectomy, Bladder Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BladderScan BVI 3000Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Accuracy of a Portable Ultrasound Scanner for Non-Invasive Bladder Volume Measurement (BladderScan BVI3000) in Patients After Radical Cystectomy and Bladder Reconstruction
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder SubstitutionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Zohar Dotan, M.D, PhD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512174
- Sponsor's protocol ID
- SHEBA-07-4629-ZD-CTIL
- Status last verified
- Aug 2007
- First submitted
- 6 Aug 2007
- Last updated
- 7 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14550437
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00512174
- Acronym / sponsor ID
- SHEBA-07-4629-ZD-CTIL
- Conditions
- Bladder Substitution, Reconstructed Bladder
- Keywords
- Portable Ultrasound Scanner, Non Invasive Bladder Volume Measurement, Radical Cystectomy, Bladder Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2007
- First posted
- 7 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BladderScan BVI 3000 | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2007.
- Background: PubMed 14550437Byun 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zohar Dotan, M.D, PhD principal investigator
Chaim Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BladderScan BVI 3000 in people with Bladder Substitution and Reconstructed Bladder, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Lindner, M.D (972-3-5302701, uri.lindner@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00512174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2007.