Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

NCT04502095 ↗

Phase 4 Completed 89 enrolled Roswell Park Cancer Institute

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

Timeline

Start: 2020-09-02
Primary completion: 2025-03-13
Completion: 2025-03-13

Outcome

Met primary endpoint

paper Ten patients (25%) developed UTIs in the SOC vs 0% in the study arm (P = .001). PMID 40279497 ↗

Publications

Hussein AA, Mahmood AW, Ahmad A, Houenstein H, Harrington G, Khan M, Abdelhaq D, Jing Z, Attwood K, Almyroudis NG, Li Q, Guru KA. Do Prophylactic Antibiotics Decrease the Rate of Urinary Tract Infections After Robot-Assisted Radical Cystectomy? A Randomized Controlled Trial. J Urol. 2025 Aug;214(2):147-155. doi: 10.1097/JU.0000000000004586. Epub 2025 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitrofurantoin	Unknown	100 mg	Oral
Subject	trimethoprim-sulfamethoxazole	Unknown	160 mg	Oral
Subject	trimethoprim-sulfamethoxazole	Unknown	800 mg	Oral
Background	Clindamycin	Unknown	—	Oral
Background	Ertapenem	Small molecule	—	Oral
Background	Levofloxacin	Small molecule	—	Oral