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NCT Number: NCT06190197

Prophylactic Antibiotics in Cystectomy With Diversion

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.

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Key information

Conditions

Muscle-Invasive Bladder Carcinoma Ileal Conduit Neobladder Diversion Radical Cystectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Judith Graziano

CONTACT

[email protected]

612-625-7486

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Prophylactic antibiotics postoperatively.

Drug

Prophylactic antibiotics postoperatively. All participants in this arm will receive nitrofurantoin 100 milligrams by mouth daily for either 10 or 21 days based on whether they had an ileal conduit or orthotopic neobladder, respectively, for the diversion. Participants will be instructed to swallow the capsule whole, preferably with food and at the same time each day. If a dose is forgotten, participants will be asked to take it when they remember and then take the next dose as usual. However, if they do not remember until the next dose, do not take extra capsules to make up the missed dose.

Primary outcomes

  1. test for non-inferiority

    Time frame: 90 days

    Test for non-inferiority of no 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.

  2. Difference in risk

    Time frame: 30 and 90 days

    Difference in risk of UTI within the first 30 days postoperative between treatment and no treatment groups.

    2-sample, 2-sided, t-test for a difference in proportions. Statistical hypothesis: H0: R1 - R2 = 0, Hα: R1 - R2 ≠ 0, where R1 is the risk (proportion) of UTI infection within the first 30 days, post operation, among those in the treatment group, and R2 among placebo.

Study contacts

Contact information is provided by the study sponsor or research team.

Judith Graziano

CONTACT

[email protected]

612-625-7486

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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