Do Prophylactic Antibiotics Decrease the Rate of Urinary Tract Infections after Robot-Assisted Radical Cystectomy? A Randomized Controlled Trial
Abstract
OBJECTIVE
To investigate the role of prophylactic antibiotics after robot-assisted radical cystectomy (RARC) in the prevention of 90-day urinary tract infections (UTIs).
METHODS
Patients who underwent RARC with urinary diversion were randomized to standard of care (SOC) versus receiving prophylactic antibiotics (Nitrofurantoin 100 mg daily or trimethoprim/sulfamethoxazole 160/800 mg daily) for 30 days after discharge. The primary endpoint was 90-day UTIs (defined as positive urine culture with >105 cfu/ml associated with clinical symptoms, such as fever, chills, or flank pain). Secondary endpoints included adverse events, 90-day infectious complications, UTI-related readmissions, and cost.
RESULT
The final cohort included 40 in the SOC and 37 patients in the study arm, with follow-up≥ 90 days. Median age was 69 years (IQR 65-76), 19 (25%) were females, and 28 (36%) received neoadjuvant chemotherapy. Ten patients (25%) developed UTIs in the SOC vs 0% in the study arm (p=0.001). There was no significant difference in complications or high-grade complications. 90-day infectious complications were 43% in the SOC arm vs 14% in the study arm (p=0.006), and 90-day infection-related readmissions were 30% in the SOC versus 5% in the study arm (p=0.007). The mean post-cystectomy cost was $9074 lower in the treatment arm compared to the SOC (p=0.007). The number needed to treat to prevent a single UTI was 4.0 (95% CI 2.5-7.0).
CONCLUSION
Prophylactic antibiotics for 30 days after RARC…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 37 participants or records.
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