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Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon) (Cranberry)

Primary Purpose

Bladder Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infection prophylaxis
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient aged > 18 years old
  • patient with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty
  • signed informed consent
  • patient with healthcare insurance

Exclusion Criteria:

  • patient without signed informed consent
  • patient deprived of liberty by judicial or administrative decision

Sites / Locations

  • Hôpital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prophylactic efficacy of Urell®

Arm Description

Prophylactic efficacy of Urell® on urinary tract infections in patients with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty

Outcomes

Primary Outcome Measures

Number of infectious events
Number of symptomatic and non-symptomatic events

Secondary Outcome Measures

Digestive tolerance
Assessment on the date of resumption of transit, nausea and vomiting

Full Information

First Posted
June 11, 2019
Last Updated
April 6, 2020
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT03986398
Brief Title
Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)
Acronym
Cranberry
Official Title
Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why 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
Study Start Date
April 14, 2019 (Actual)
Primary Completion Date
February 9, 2020 (Actual)
Study Completion Date
February 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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%). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic efficacy of Urell®
Arm Type
Experimental
Arm Description
Prophylactic efficacy of Urell® on urinary tract infections in patients with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty
Intervention Type
Other
Intervention Name(s)
Infection prophylaxis
Intervention Description
Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)
Primary Outcome Measure Information:
Title
Number of infectious events
Description
Number of symptomatic and non-symptomatic events
Time Frame
From study treatment start until 21 days of treatment
Secondary Outcome Measure Information:
Title
Digestive tolerance
Description
Assessment on the date of resumption of transit, nausea and vomiting
Time Frame
From study treatment start until 21 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient aged > 18 years old patient with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty signed informed consent patient with healthcare insurance Exclusion Criteria: patient without signed informed consent patient deprived of liberty by judicial or administrative decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Butreau
Organizational Affiliation
Urology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Learn more about this trial

Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)

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