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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 9, 2020

Interventions

  • Other: Infection prophylaxis
    • Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of infectious events
    • Time Frame: From study treatment start until 21 days of treatment
    • Number of symptomatic and non-symptomatic events

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hopital Foch
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martine Butreau, Principal Investigator, Urology department

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