Prophylactic Antibiotics in Cystectomy With Diversion

Prophylactic Antibiotics in Radical Cystectomy With Urinary 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.

Study Overview

• Status: Recruiting
• Conditions: Muscle-Invasive Bladder Carcinoma; Radical Cystectomy; Ileal Conduit; Neobladder Diversion
• Intervention / Treatment: Drug: Prophylactic antibiotics postoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Judith Graziano; Phone Number: 612-625-7486; Email: grazi005@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Judith Graziano; Phone Number: 612-625-7486; Email: grazi005@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
test for non-inferiority	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.	90 days
Difference in risk	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.	30 and 90 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Hamed Ahmadi, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: URO-2023-32133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No