Ultrasound-Tuned Antimicrobial Hydrogel–Coated Urinary Catheters Reduce Catheter-Associated Urinary Tract Infection: A Randomized Controlled Trial

Background: Catheter-associated urinary tract infection remains a frequent healthcare-associated infection, largely driven by microbial adhesion and biofilm formation on catheter surfaces. Conventional antimicrobial coatings have shown inconsistent effectiveness because of passive release kinetics and declining activity over time. Objective: To compare catheter-associated urinary tract infection rates between ultrasound-tuned antimicrobial hydrogel–coated urinary catheters and standard uncoated silicone catheters. Methods: This prospective parallel-group randomized controlled trial enrolled 60 hospitalized adults requiring indwelling urinary catheterization for at least 72 hours. Participants were allocated equally to an ultrasound-tuned antimicrobial hydrogel–coated catheter group or a standard catheter group. The intervention group received daily low-intensity ultrasound activation, while both groups received standardized catheter care. The primary outcome was clinically assessed and microbiologically confirmed catheter-associated urinary tract infection. Secondary outcomes included urine colony count, time to infection onset, symptomatic infection, and adverse events. Results: Catheter-associated urinary tract infection occurred in 1/30 participants (3.3%) in the ultrasound-tuned hydrogel group and 5/30 participants (16.7%) in the standard catheter group, representing an absolute risk reduction of 13.4 percentage points and an estimated relative risk of 0.20. Mean urine colony count was lower in the intervention group (2.1 × 10⁴ ± 0.8 × 10⁴ CFU/mL) than in the control group (6.7 × 10⁴ ± 1.9 × 10⁴ CFU/mL; p = 0.01). No catheter-related or ultrasound-associated complications were reported. Conclusion: Ultrasound-tuned antimicrobial hydrogel–coated catheters were associated with reduced infection risk and bacterial burden during short-term inpatient catheterization.