Bladder CancerCranberryNCT03986398
Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)
A study testing Infection prophylaxis in people with Bladder Cancer, run by Hopital Foch at 1 site in France.
Trial summary
Total prostatic cystectomy with enterocystoplasty is the most extensive urological surgical procedure and one with the highest complication rate, especially infectious complication. The mortality rate remains substantial (2 to 5%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Infection prophylaxis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2019to 9 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged > 18 years old
- patient with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty
- signed informed consent
- patient with healthcare insurance
Who cannot join
- patient without signed informed consent
- patient deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Total prostatic cystectomy with enterocystoplasty is the most extensive urological surgical procedure and one with the highest complication rate, especially infectious complication. The mortality rate remains substantial (2 to 5%).
Examination of hundreds of TPCs made every year in the Urology Department of Foch Hospital, shows that nosocomial urinary infection is constant, especially when the TPC is followed by the constitution of an ileal bladder replacement.
Read more
This is due to the intervention itself and duration of postoperative urinary cathéters (ureteral and bladder). This leads to increase surveillance and antibiotic treatment, given the risks of declared infection in this context.
Detailed analysis of the last 20 TPCs with enterocystoplasty showed the presence of germs in significant numbers, in all cases.
Urell® (also sold under the Trademark Ellura®) contains a cranberry juice extract with a high content of bioactive, soluble Proanthocyanidins (PACs) . The daily dose is 36 mg total PACs measured by the DMAC/A2 method. The PACs prevent uropathogenic E.col bacteria from adhering to uroepithelial cells . Their long term use does not create any resistance of the bacteria.
The excellent prophylactic effet of Urell® had been previously observed in the same Center under different conditions.
Therefore a further demonstration was justified, of the prophylactic efficacy of Urell® in the perioperative setting of total prostato-cystectomy with substitute enterocytoplasty, where the slightest urinary infection, symptomatic or not, prolongs hospitalization and requires antibiotic treatment because of its harmful and sometimes major consequences.
- Conditions
- Bladder Cancer
- Being tested
- Infection prophylaxis
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infection prophylaxisOther
Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic efficacy of Urell® | Experimental | Prophylactic efficacy of Urell® on urinary tract infections in patients with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty Receives: Other: Infection prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infectious events
Number of symptomatic and non-symptomatic events
Measured: From study treatment start until 21 days of treatment
Secondary outcomes (1)
Digestive tolerance
Assessment on the date of resumption of transit, nausea and vomiting
Measured: From study treatment start until 21 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start14 Apr 2019
- Primary completion9 Feb 2020
- Study completion9 Feb 2020
Why it stopped: In the perioperative setting of radical cystectomy-bladder replacement no improvement of UTI was noticed in 10 patients who took Urell following the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine Butreau, Principal investigator, Urology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986398
- Sponsor's protocol ID
- 2018045
- Acronym
- Cranberry
- Status last verified
- Apr 2020
- First submitted
- 11 Jun 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)
- ClinicalTrials.gov ID
- NCT03986398
- Acronym / sponsor ID
- Cranberry / 2018045
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In the perioperative setting of radical cystectomy-bladder replacement no improvement of UTI was noticed in 10 patients who took Urell following the protocol
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 9 Feb 2020 (actual)
- First posted
- 14 Jun 2019 (actual)
- 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.
Total prostatic cystectomy with enterocystoplasty is the most extensive urological surgical procedure and one with the highest complication rate, especially infectious complication. The mortality rate remains substantial (2 to 5%).
Examination of hundreds of TPCs made every year in the Urology Department of Foch Hospital, shows that nosocomial urinary infection is constant, especially when the TPC is followed by the constitution of an ileal bladder replacement.
This is due to the intervention itself and duration of postoperative urinary cathéters (ureteral and bladder). This leads to increase surveillance and antibiotic treatment, given the risks of declared infection in this context.
Detailed analysis of the last 20 TPCs with enterocystoplasty showed the presence of germs in significant numbers, in all cases.
Urell® (also sold under the Trademark Ellura®) contains a cranberry juice extract with a high content of bioactive, soluble Proanthocyanidins (PACs) . The daily dose is 36 mg total PACs measured by the DMAC/A2 method. The PACs prevent uropathogenic E.col bacteria from adhering to uroepithelial cells . Their long term use does not create any resistance of the bacteria.
The excellent prophylactic effet of Urell® had been previously observed in the same Center under different conditions.
Therefore a further demonstration was justified, of the prophylactic efficacy of Urell® in the perioperative setting of total prostato-cystectomy with substitute enterocytoplasty, where the slightest urinary infection, symptomatic or not, prolongs hospitalization and requires antibiotic treatment because of its harmful and sometimes major consequences.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Prophylactic efficacy of Urell® | Experimental | Other: Infection prophylaxisProphylactic efficacy of Urell® on urinary tract infections in patients with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient aged > 18 years old
- patient with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty
- signed informed consent
- patient with healthcare insurance
Key exclusion criteria (2 listed)
- patient without signed informed consent
- patient deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Infection prophylaxisInfection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon) | Other | Prophylactic efficacy of Urell® |
Primary outcome
Number of infectious events
Time frame: From study treatment start until 21 days of treatment
Number of symptomatic and non-symptomatic events
1 secondary outcome
Digestive tolerance
Time frame: From study treatment start until 21 days of treatment
Results and safety
The study was stopped early (reason given: In the perioperative setting of radical cystectomy-bladder replacement no improvement of UTI was noticed in 10 patients who took Urell following the protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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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.
Martine Butreau principal investigator
Urology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infection prophylaxis in people with Bladder Cancer, run by Hopital Foch at 1 site in France.
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 4 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: stopped early, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study was stopped early (reason given: In the perioperative setting of radical cystectomy-bladder replacement no improvement of UTI was noticed in 10 patients who took Urell following the protocol). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infectious events (time frame: From study treatment start until 21 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2020.