Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic-associated Diarrhea | — | UNRESOLVED | — |
| Antibiotic Resistant Infection | — | UNRESOLVED | — |
| Antibiotic Resistant Strain | — | UNRESOLVED | — |
| Antibiotic Toxicity | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Hyperplasia | — | UNRESOLVED | — |
| Urosepsis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levofloxacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.
- interventionNames
- Drug: Levofloxacin
- type
- NO_INTERVENTION
- label
- Treatment group
- description
- The treatment group receives no AMP.
Primary outcomes (1)
- measure
- % of patients with a post-operative infection.
- timeFrame
- From immediately post-op until at the control consultation 4 weeks after surgery.
- description
- Urosepsis, fever (t°\> 38.5) or epididymitis.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available