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

NCT03986398 | Terminated

• 1 other identifier: 2018045
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Number of infectious events

  Number of symptomatic and non-symptomatic events

  From study treatment start until 21 days of treatment

Secondary Outcomes (1)

• Digestive tolerance

  From study treatment start until 21 days of treatment

Study Arms (1)

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

Other: Infection prophylaxis

Interventions

Infection prophylaxis OTHER

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

Prophylactic efficacy of Urell®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Martine Butreau

  Urology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: April 14, 2019
• Primary Completion: February 9, 2020
• Study Completion: February 9, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

FR (1)