JU INSIGHT Prospective Study Using a Novel Safety Valve to Prevent Catheter Balloon Inflation Injury of Urethra

By: Eabhann M. O’Connor, MD, Beaumont Hospital, Dublin, Ireland; Stefanie M. Croghan, MD, Royal College of Surgeons, Dublin, Ireland; Olivia Baird, MD, University Hospital Limerick, Ireland; John Fallon, MD, University Hospital Limerick, Ireland; Peter Loughman, MD, University Hospital Limerick, Ireland; Jibraan Esoof, MD, University Hospital Limerick, Ireland; Robert A. Keenan, MD, Beaumont Hospital, Dublin, Ireland; James Ryan, MD, Beaumont Hospital, Dublin, Ireland; Rustom Manecksha, MD, Tallaght University Hospital, Dublin, Ireland; Frank D’Arcy, MD, Galway University Hospital, Ireland; Helen Purtill, MD, University of Limerick, Ireland; Raghav Varma, MD, Hereford County Hospital, United Kingdom; Helen Thursby, MD, Hereford County Hospital, United Kingdom; Amber Matkowski, MD, Hereford County Hospital, United Kingdom; Sami El Hadi, MD, Hereford County Hospital, United Kingdom; Wasim Mahmalji, MD, Hereford County Hospital, United Kingdom; Subhasis K. Giri, MD, University Hospital Limerick, Ireland | Posted on: 20 Jul 2023

O’Connor EM, Croghan SM, Baird O, et al. A prospective multi-institutional study using a novel safety valve for the prevention of catheter balloon inflation injury of the urethra. J Urol. 2023;210(1):179-185.

Study Need and Importance

Catheter balloon injury (CBI) of the urethra can result in patient morbidity and significant cost to health services. A prospective, multi-institution study was conducted to evaluate the transurethral catheterization safety valve, which was conceived and designed with the goal of preventing CBI. The novel device is designed to prevent inadvertent inflation of the catheter’s anchoring balloon in the urethra during urethral catheterization. “Venting” through the safety valve during catheterization was indicative of a prevented CBI (see Figure).

Figure. 1, Catheter balloon preinflation testing without using the transurethral catheterization safety valve. 2, Activation of safety valve by removing red pull-away tab. 3, Connection of balloon-inflating syringe (Luer lock or slip) with safety valve, safety valve slip with catheter balloon inflation port, then catheterization. 4, Catheter balloon inflation followed by removal of the syringe and safety valve together immediately after inflation to avoid balloon deflation by pressurized backflow. 5, Indicates transurethral catheterization safety valve venting (fluid leak) and signaling the user when the balloon has been inadvertently inflated in the urethra.

What We Found

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 CBIs 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. Health economic outcomes were also evaluated. In the base case analysis, the use of the safety valve with standard of care catheterization with a Foley catheter resulted in both quality-adjusted life year gains (0.02 quality-adjusted life years per patient) and cost savings (£93.19 per patient) over a lifetime horizon.

Limitations

As urologists, we are not called to every injury that may happen where an initially malpositioned catheter is reinserted successfully. As such, the overall total number of CBIs is likely to be underestimated.

Interpretations for Patient Care

Safety valve use reduces the rate of and has the potential to eliminate urethral CBI if widely adopted. It has the benefit of allowing use with all commercially available catheters and is significantly less expensive than specialized urinary catheters.