Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB) (Prophylaxis001)

A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or > 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer; Antibiotic-associated Diarrhea; Antibiotic Resistant Infection; Antibiotic Resistant Strain; Antibiotic Toxicity; Prostate Hyperplasia; Urosepsis
• Intervention / Treatment: Drug: Levofloxacin

Detailed Description

Main objective:

To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or > 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).

Secondary objective:

To investigate post-operative bacteriuria after TURB and TURP in our population.

Principal inclusion criterium:

Patients undergoing TURP or TURB.

Primary exclusion criterium:

TURP: pre-operative catheter or > 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).

Primary endpoint:

Post-operative infection.

Secondary endpoint:

Post-operative bacteriuria.

• Study Type: Interventional
• Enrollment (Actual): 1350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3050
      • Jessa Ziekenhuis

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:

• TURP or TURB.

Exclusion Criteria:

• TURP: pre-operative catheter/DJ/nephrostomy or > 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.	Drug: Levofloxacin; The control group receives AMP.
No Intervention: Treatment group; The treatment group receives no AMP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with a post-operative infection.	Urosepsis, fever (t°> 38.5) or epididymitis.	From immediately post-op until at the control consultation 4 weeks after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-operative bacteriuria.	> 100.000 bacteria/mL urine	From immediately post-op until at the control consultation 4 weeks after surgery.

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Koenraad van Renterghem, PhD, UHasselt

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): December 23, 2019

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 27, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: TURB; TURP
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Signs and Symptoms, Digestive; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Diarrhea; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: JessaH_B243201733480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No