Antimicrobial catheters coated with poly-L-lysine for the prevention of bacteriuria in adults requiring short-term catheterization: a multicenter randomized controlled trial

To evaluate the safety and efficacy of a newly developed catheter coated with antimicrobial poly-L-lysine (PLL) in reducing the risk of catheter-associated bacteriuria. A prospective, multicenter, randomized controlled noninferiority trial was conducted among patients who required indwelling catheterization between February 23, 2023, and January 30, 2024. The experimental group used antimicrobial PLL catheters, and the control group used noble metal alloys (NMA) coated catheters. The primary outcome was the incidence of catheter-associated bacteriuria. The secondary outcome was the total bacterial count per unit surface area of the catheter body in the urethra after catheterization. The safety evaluation included complications related to catheterization. The noninferiority threshold was set at 10%. Three hundred patients were enrolled, while the full analysis set (FAS) included 150 patients who received PLL catheters and 150 patients who received NMA catheters. There were 10 cases (6.9%) of bacteriuria in the experimental group and 15 cases (10.1%) in the control group. The difference in the incidence of bacteriuria between the experimental and control groups was − 3.1% (95% CI − 7.2%, 6.6%, p = 0.3195). Four patients experienced symptoms compared to 6 in the control group during catheterization ( p = 0.750). The proportion of patients experiencing abnormal urine white blood cells in the experimental group was lower (6.2% vs. 12.8%, p = 0.0194). The incidence of catheter-related adverse events was 3 cases (2.0%) in the experimental group and 6 cases (4.0%) in the control group ( p = 0.5011). The short-term use of PLL catheters demonstrated noninferior efficacy in preventing bacteriuria compared with NMA catheters. The PLL catheters have good safety profile and low toxicity. Further trials involving more patients and long duration period are imperative to demonstrate the generalizability of the findings. This study was registered at https://www.chictr.org.cn/showproj.html?proj=188879 on February 3, 2023, and ID is ChiCTR2200059331.