Prophylactic Antibiotics in Cystectomy With Diversion

Early Phase 1

Recruiting

• Conditions: Muscle-Invasive Bladder Carcinoma; Ileal Conduit; Neobladder Diversion; Radical Cystectomy
• Interventions: Drug: Prophylactic antibiotics postoperatively.

• Registration Number: NCT06190197
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-05
• Study Start: 2024-05-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-10-15
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Prophylactic antibiotics postoperatively.	Prophylactic antibiotics postoperatively.

Primary Outcome Measures

Name	Time	Method
test for non-inferiority	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.
Difference in risk	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States