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Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy (Abx)

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University of Rochester

Status

Terminated

Conditions

Urinary Tract Infection
Clostridium Difficile
Prostate Cancer

Treatments

Drug: Ciprofloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT02247960
RSRB#50607

Details and patient eligibility

About

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.

Enrollment

175 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

175 participants in 2 patient groups

Ciprofloxacin
Active Comparator group
Description:
Antibiotic
Treatment:
Drug: Ciprofloxacin
No Antibiotic
No Intervention group
Description:
No Antibiotic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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