Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy (Abx)
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ClinicalTrials.gov Identifier: NCT02247960
Recruitment Status :
(Interim analysis determined that the study should be concluded for futility.)
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.
Number of Participants With a Positive Urinary Tract Infection [ Time Frame: 12 months ]
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 Outcome Measures :
Number of Participants Positive for Clostridium Difficile [ Time Frame: 3 months ]
Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).
Number of Participants With Bacteria in Urine [ Time Frame: 3 months ]
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.
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.