Recruiting
Early Phase 1

Nitrofurantoin vs. No Therapy

Sponsor:

University of Minnesota

Code:

NCT06190197

Conditions

Muscle-Invasive Bladder Carcinoma

Radical Cystectomy

Ileal Conduit

Neobladder Diversion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prophylactic antibiotics postoperatively.

Study Details

Brief summary:

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.

Conditions

Muscle-Invasive Bladder Carcinoma

Radical Cystectomy

Ileal Conduit

Neobladder Diversion

Study ID

NCT06190197

Start date

May 13, 2024

Status verified date

Nov, 2025

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control group

No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection

experimental: Treatment group

Prophylactic antibiotics postoperatively.

Interventions

Prophylactic antibiotics postoperatively.

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 outcome measure

  • test for non-inferiority [ Time Frame: 90 days ]
  • Difference in risk [ Time Frame: 30 and 90 days ]

Central Contacts and Locations

Central contacts

Judith Graziano

612-625-7486grazi005@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Judith Graziano

612-625-7486grazi005@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Nov 17, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-11-17.