Cathal Flood, Nikita R. Bhatt, Jay Budrewicz, Barry Rickman, Michael Walsh, Hugh Flood, and Niall Davis. IP10-26: 'Further Validation of the Transurethral Catheterization Safety Valve (TUCSV) Pressure Threshold in a Porcine Model.’ Presented at: the American Urological Association meeting, AUA 2026.
ABSTRACT: Inadvertent inflation of a catheter anchoring ballon in the urethra can cause urethral rupture due to high balloon inflation pressures. Bleeding, urosepsis and late urethral stricture are common complications. A pressure relief valve has been developed to protect against catheter balloon injury (CBI). The TUCSV opening pressure is set at 150 kPa (range 140-170 kPa). The FDA has requested that the safety of the venting pressure window of 140-170 kPa be confirmed for the device by comparing, in an ex-vivo urethral model, the integrity of the urethra at an inflation pressure of 100 vs 170 kPa (15 vs 25 psi). The objective of this study was to confirm that inflation of the anchoring balloon of a urinary catheter at 25 psi produces no significant additional urethral tissue changes compared to inflation at 15 psi in a porcine model used in previous reports.
METHODS: This study was run under Good Laboratory Practice (GLP) conditions. Proximal urethras from 5 male Yorkshire swine between 6 and 7 months old were harvested and utilized fresh to evaluate for any acute urethral injury after inflation of the 5cc anchoring balloon of a14 F, 100% silicone Foley catheter to a pressure of either 15 psi (control) or 25 psi (test). Test and control treatments were performed in each urethra at either proximal or distal locations according to a pre-determined treatment matrix. After testing, the urethra was evaluated and macroscopically scored for any tissue damage. Urethra sections from balloon treated sites and proximal and distal to the treated area were processed for histopathologic evaluation. Areas proximal and distal to the treated area had morphometric wall thickness measurements performed.
RESULTS: Inflation of all catheters to their pre-determined balloon inflation pressures were successful. No noticeable external urethral damage upon balloon inflation, deflation or removal was observed. In all specimens, there was no macroscopic injury or evidence of tissue damage/tears within the urethra. No abnormal histologic findings including mucosal, submucosal, and muscular tears, or collagen and elastin fiber damage, tearing, or separation were observed in test (25 psi) or control (15 psi) groups. Urethral wall thickness was comparable for the two groups.
CONCLUSIONS: The absence of any urethral injury at a TUCSV venting threshold pressure of 25psi (170kPa) combined with 60,000 units sold in Europe without reported CBI underlines the importance of this device in achieving safer urinary catheterization.
Journal of Urology [Internet]. 2026 May 1 [cited 2026 May 26];215(5S):e223. https://doi.org/10.1097/01.JU.0001191320.09030.8b.26
Presented at AUA 2026, May 15, in Washington, DC.