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  • Title: A Prospective Multi-institutional Study Using a Novel Safety Valve for the Prevention of Catheter Balloon Inflation Injury of the Urethra.
    Author: O'Connor EM, Croghan SM, Baird O, Fallon J, Loughman P, Esoof J, Keenan RA, Ryan J, Manecksha R, D'Arcy F, Purtill H, Varma R, Thursby H, Matkowski A, El Hadi S, Mahmalji W, Giri SK.
    Journal: J Urol; 2023 Jul; 210(1):179-185. PubMed ID: 37000009.
    Abstract:
    PURPOSE: We prospectively assessed the ability of a novel transurethral catheterization safety valve to prevent urethral catheter balloon injury in a multi-institutional clinical setting. MATERIALS AND METHODS: A prospective, multi-institution study was conducted. The safety valve was introduced for urinary catheterization in 6 hospital groups (4 in Ireland; 2 in the UK). The safety valve allows fluid in the catheter system to vent through a pressure relief valve if attempted intraurethral inflation of the catheter's anchoring balloon occurs. Device usage was studied over a 12-month period, with data recorded using a 7-item data sticker containing a scannable QR code. "Venting" through the safety valve during catheterization was indicative of prevention of a urethral injury. An embedded 3-month study was conducted in 3 centers, with any catheter balloon injuries occurring during catheterization without safety valve use referred to the on-call urology team recorded. Health economic analyses were also performed. RESULTS: During the overall 12-month device study phase, 994 urethral catheterizations were performed across study sites. Twenty-two (2.2%) episodes of safety valve venting were recorded. No urethral injuries occurred in these patients. In the embedded 3-month study, 18 catheter balloon injuries were recorded in association with catheterizations performed without the safety valve. Based on confirmed and device-prevented urethral injuries, the injury rate for urethral catheterization without safety valve use was calculated to be 5.5/1,000 catheterizations. CONCLUSIONS: The safety valve has the potential to eliminate catheter balloon injury if widely adopted. It represents a simple, effective, and innovative solution to this recurring problem applicable to all patient cohorts.
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