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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04212403

Acronym

Prophylaxis001

Enrollment

1350

Registered

2019-12-27

Start date

2018-09-17

Completion date

2019-12-23

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic-associated Diarrhea, Antibiotic Resistant Infection, Antibiotic Resistant Strain, Antibiotic Toxicity, Bladder Cancer, Prostate Hyperplasia, Urosepsis

Keywords

TURP, TURB

Brief summary

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.

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.

Interventions

DRUGLevofloxacin

The control group receives AMP.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Intervention model description

Randomized, controlled trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026