Poly-L-lysine–Coated Catheters: Effective and Safe for Prevention of Catheter-Associated UTI: Study
Researchers have found in a new study that Poly-L-lysine (PLL)–coated urinary catheters are safe, well-tolerated, and noninferior to noble metal alloy (NMA)–coated catheters in preventing bacteriuria among adults requiring short-term catheterization. With Level 1 (excellent) evidence, PLL-coated catheters represent an effective alternative for CAUTI prevention. This is clinically important given that catheter-associated urinary tract infections (CAUTI) account for around 40% of all hospital-acquired infections, contributing to increased morbidity, prolonged hospital stays, and higher healthcare costs. The study was published in BMC Medicine by Xinfei Li and colleagues.
The trial was carried out from February 23, 2023, to January 30, 2024. A total of 300 patients requiring an indwelling urinary catheterization were enrolled and comprised the full analysis set. Of these, 150 patients were assigned to the experimental group and received PLL-coated catheters, while 150 patients in the control group received NMA-coated catheters.
The primary endpoint was the incidence of catheter-associated bacteriuria. Secondary endpoints were the total bacterial count per unit surface area of the catheter body in the urethra after catheterization. Safety evaluations were centered on complications and catheter-related adverse events. The trial was a noninferiority trial, with a noninferiority margin of 10%, indicating that if the difference in bacteriuria rates did not exceed this margin, the PLL catheter would be considered noninferior.
Key findings
In a total of 300 patients, 10 patients in the PLL group and 15 patients in the NMA group had bacteriuria, with an incidence of 6.9% and 10.1%, respectively.
The absolute difference of bacteriuria incidence was -3.1%, with a 95% confidence interval of -7.2% to 6.6% (p = 0.3195), satisfying the criteria for noninferiority with a 10% margin.
The incidence of symptomatic patients during catheterization was 4 (6.0%) in the PLL group and 6 (9.0%) in the NMA group (p = 0.750), which showed no statistically significant difference between the two groups.
The incidence of patients with abnormal urine white blood cell counts was significantly lower in the PLL group at 6.2%, compared with 12.8% in the NMA group (p = 0.0194), which indicated a possible benefit in reducing inflammation.
The incidence of catheter-related adverse events was 3 (2.0%) in the PLL group and 6 (4.0%) in the NMA group (p = 0.5011), which showed no statistically significant difference between the two groups.
In this multi-center randomized controlled trial conducted among 300 patients, PLL-coated catheters showed non-inferior efficacy to NMA-coated catheters in the prevention of catheter-associated bacteriuria, with an incidence of 6.9% and 10.1%, respectively. The safety results were also favorable, with low rates of adverse events and no significant increase in complications. These results provide evidence for the short-term application of PLL-coated catheters. However, further studies are required to confirm these findings.
Reference:
Li, X., Liu, J., Zuo, S. et al. Antimicrobial catheters coated with poly-L-lysine for the prevention of bacteriuria in adults requiring short-term catheterization: a multicenter randomized controlled trial. BMC Med (2026). https://doi.org/10.1186/s12916-026-04686-2
