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

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 Overview

• Status: Terminated
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: Infection prophylaxis

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hôpital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prophylactic efficacy of Urell®; Prophylactic efficacy of Urell® on urinary tract infections in patients with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty	Other: Infection prophylaxis; Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infectious events	Number of symptomatic and non-symptomatic events	From study treatment start until 21 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digestive tolerance	Assessment on the date of resumption of transit, nausea and vomiting	From study treatment start until 21 days of treatment

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Martine Butreau, Urology Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2019
• Primary Completion (ACTUAL): February 9, 2020
• Study Completion (ACTUAL): February 9, 2020

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: 2018045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No