Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Conditions
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Prostate Cancer, Urinary Tract Infection, Clostridium Difficile

Intervention / Treatment
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* Drug: Ciprofloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ciprofloxacin<br>Antibiotic | Drug: Ciprofloxacin<br> <br> * Other names: Cipro;|
| No Intervention: No Antibiotic<br>No Antibiotic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Positive Urinary Tract Infection | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Positive for Clostridium Difficile | Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR). | 3 months | 
| Number of Participants With Bacteria in Urine | Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive. | 3 months |