Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-05-31

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.

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Detailed Description

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Conditions

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Prostate Cancer Urinary Tract Infection Clostridium Difficile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ciprofloxacin

Antibiotic

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

No Antibiotic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ciprofloxacin

Intervention Type DRUG

Other Intervention Names

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Cipro

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No