Prophylactic Antibiotics in Cystectomy With Diversion

Recruiting now · Early Phase 1

Conditions studied: Muscle-Invasive Bladder Carcinoma, Radical Cystectomy, Ileal Conduit, Neobladder Diversion

In brief

Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.

Key facts

Study ID

NCT06190197

Run by

University of Minnesota

People needed

120

Starts

2024-05-13

Expected to finish

2027-10-15

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
• 18 years of age or older

You may not qualify if…

• Currently receiving antimicrobials for active infection
• Poor renal function with GFR < 30 ml/min
• Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
• Pregnancy
• Unable to provide Informed consent
• Prior pelvic radiation

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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