Clinical trial · Interventional
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis determined that the study should be concluded for futility.
Summary
Brief summary (as posted)
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clostridium Difficile | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Tract Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ciprofloxacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ciprofloxacin
- description
- Antibiotic
- interventionNames
- Drug: Ciprofloxacin
- type
- NO_INTERVENTION
- label
- No Antibiotic
- description
- No Antibiotic
Primary outcomes (1)
- measure
- Number of Participants With a Positive Urinary Tract Infection
- timeFrame
- 12 months
- description
- After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group. Exclusion Criteria: * Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
References
Publications (0)
Data not yet available