Introduction: Bleeding is the leading complication of outlet surgery for men with lower urinary tract symptoms, harming patients and increasing resource utilization. Our group has developed a urinary catheter which incorporates a specialized biodegradable chitosan endoluminal hemostatic dressing (CEHD) for transurethral deployment. Previous investigation focused on deployment feasibility with limited assessment of hemostatic efficacy. Methods: Hemostatic efficacy of CEHD prototypes relative to standard of care Foley catheter was investigated using a heparinized swine hepatic injury model. 2.5cm diameter concave injuries in hepatic lobes were created with a rotary cutting tool. CEHD prototype test treatments and Foley balloon catheter control treatments (N = 40, each) were randomly paired to injuries in 4 swine. Tests consisted of a prototype placed on the wound bed followed by a 10mL Foley balloon and 25g gel block to apply 35g of tamponade pressure. Controls did not include prototype dressing. Hemostasis was determined at 30s. Failures at 30s were re-applied for 90s and hemostasis reassessed. Both 30s and 90s were followed by 60s observation (up to 250s total). Bleeding rate was determined at initiation and conclusion. Hemostasis was analyzed either as no bleeding or as an >85% reduction in bleed rate. Results: Mean clotting time was 561 seconds and mean pre-treatment bleeding rate was 19.5 mL/min with no significant difference between test and control groups. The CEHD group demonstrated a significant difference in bleed rate reduction (97% vs 73%, p <0.001), and mean time to hemostasis (98s vs 287s, p < 0.001). While the Foley Balloon alone did lead to a hemostatic reduction in bleed rate (=85%) in 58% of cases, CEHD application provided rapid significantly improved hemostasis, with 38/40 CEHD prototypes achieving complete hemostasis by 3 minutes, versus only 3/40 controls (p <0.001). Conclusions: CEHD prototypes demonstrated superior hemostatic capability compared to conventional Foley balloon controls in the setting of high bleed rates. Previous investigation demonstrated in vivo feasibility of transurethral deployment, tissue adhesion and biodegradation of the device and dressing over a 7-day period. These results suggest robust hemostatic capability of the CEHD prototype in an anticoagulated in vivo model, supporting future clinical investigation. SOURCE OF Funding: NIH/NIDDK Award R42DK078400
