PD31-01: Transurethral Catheterisation Safety Valve (TUCSV&[copy]) for the Prevention of Catheter Balloon Inflation Injury of the Urethra - A Prospective Multi-institutional Study

Eabhann O'Connor, Stefanie Croghan*, Dublin, Ireland, Olivia Baird, John Fallon, Peter Loughman, Jibraan Esoof, Limerick, Ireland, Robert Keenan, James Ryan, Dublin, Ireland, Subhasis Giri, Limerick, Ireland

Introduction: Catheter balloon injuries (CBI) of the urethra are potentially devastating and avoidable iatrogenic insults that occur in up to 1.34% of male hospitalised patients. The transurethral catherisation safety valve (TUCSV©) is a novel safety device designed to prevent CBIs. The safety device allows fluid in the catheter system to vent through a pressure relief valve if the catheter’s anchoring balloon is inflated in the urethra. The aim of this multi-institutional clinical study was to prospectively assess the TUCSV’s ability to prevent urethral CBI over a 3-month study period.

Methods: The incidence of CBI was recorded in 2 Irish hospital groups over a 3 month period.  Following this, the TUCSV was introduced for urinary catheterisation in a variety of hospital settings in the primary institution of the same 2 Irish hospital groups over a 3-month study period (April-July 2021). The safety valve is compatible with all commercially available catheters.  Data were recorded using a 7-item data sticker with a scannable QR code. ‘Venting’ through the safety valve during catheterisation was indicative of a urethral injury prevented. Any CBIs referred to the Urology team on call were recorded.

Results: In total, 699 urethral catheterisations were carried out using the TUCSV, with 12 (1.7%) episodes of TUCSV venting recorded. There were no urethral injuries in these patients. In the same period, 13 urethral CBIs were recorded where the TUCSV was not utilised. This suggests that the true incidence of CBI is substantially greater than that based on cases referred to Urology only. The injury rate was 5.9/1000 catheterisations.

Conclusions: This prospective multi-institutional study has demonstrated that use of the TUCSV reduces the rate of and has the potential for the first time to eliminate CBI of the urethra if widely adopted. No injuries occurred with use of the device and up to 12 were directly prevented. The TUCSV offers an effective and practical solution to the recurring problem of iatrogenic urethral injury and provides users with greater confidence during catheterisation.

Source of Funding: TUCSV were provided by Class Medical Ltd.