A Urinary Bag Accessory for Reducing Catheter-Associated Urinary Tract Infections

Background: Catheter-associated urinary tract infections (CAUTIs) are still the most common healthcare-associated infections globally. Although catheter designs have improved, based on the duration of use, such as indwelling catheters, substantial numbers of infections are still caused by contamination from the collection bag (intraluminal) and from the external catheter's surface (extraluminal). This study assessed the safety and practicality of a novel silver-based device designed for external attachment between a catheter outlet and a urine collection bag to stop bacteria from traveling up from the urine bag into the bladder through the inside of the tube. Methods: The accessory features a silver ion-releasing polymer matrix with a synergistic formulation and an anti-reflux valve to prevent urine backflow. Laboratory tests included microbial adherence, 10-day biofilm formation, and MIC assays against common uropathogens. Biocompatibility was assessed by ISO 10993-5. A pilot clinical trial randomized 157 catheterized patients (80 received the antiseptic accessory, 77 were controls) to evaluate safety and initial efficacy. Results: Laboratory studies showed that the matrix material reduced all tested microbes by at least 5 log and had minimum inhibitory concentrations (MICs) of 0.15–0.3 ppm for silver ions. Cytotoxicity testing found it to be non-cytotoxic (Grade 0–2). In clinical assessments, the accessory was evaluated for CAUTI-related organisms by comparing urine samples from the bag and catheter port. The accessory reduced intraluminal infection incidence in half (5.6% vs. 9.6%) and no device-related adverse events were reported. Conclusions: The accessory device was biocompatible, well tolerated, and showed strong antimicrobial activity against common CAUTI pathogens. It may help prevent intraluminal infections, but not overall CAUTI due to extraluminal infection via the catheter surface. More research is needed to confirm the benefits of this concept.