Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Not Applicable

Terminated

• Conditions: Clostridium Difficile; Prostate Cancer; Urinary Tract Infection
• Interventions: Drug: Ciprofloxacin

• Registration Number: NCT02247960
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-25
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-01-25
• Results First Submitted QC: 2017-01-25
• Status Verified: 2017-03
• Results First Posted: 2017-03-15
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 175

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin	Ciprofloxacin	Antibiotic

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Positive Urinary Tract Infection	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

Name	Time	Method
Number of Participants Positive for Clostridium Difficile	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	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States