Clinical Evaluation of a Safety-device to Prevent Urinary Catheter Inflation Related Injuries

Davis, Niall F.; Cunnane, Eoghan M.; Mooney, Rory; Forde, James; Walsh, Michael T.

doi:10.1016/j.urology.2018.02.026

Cited by 12 publications

(7 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The iatrogenic injury of the urethra and related complications were associated with significant cost and longer hospital LOS (25). Although some studies were conducted to design a safer urinary catheter system to prevent catheterization-related urinary injuries (26,27), iatrogenic urinary injuries continued to occur. However, for patients without catheterization in our study, the risk of iatrogenic injury of the urethra could be avoided.…”

Section: Discussionmentioning

confidence: 99%

A Novel Tubeless Urinary Catheter Protocol Enhanced Recovery After Minimally Invasive Lung Surgery

et al. 2020

View full text Add to dashboard Cite

Objectives: Although previous studies have shown the feasibility of non-intubated techniques, it is unknown whether avoiding urinary catheters can enhance recovery. This study aimed to determine whether the tubeless urinary catheter protocol is feasible and beneficial for minimally invasive lung surgery. Methods: Patients were randomized to the control group, completely tubeless group, and partially tubeless group. A propensity score–matched (PSM) analysis was performed to balance the non-random baseline characteristics. Complications and postoperative recovery were compared. Regression analysis was performed to identify the independent predictors of complications. A nomogram for predicting the risk of non-automatic micturition was constructed and internally validated. Results: One hundred fifty-nine patients were enrolled. The incidence rates of urinary irritation and urinary tract infection (UTI) were significantly lower in the tubeless groups (74.4 vs. 39.5%, p < 0.001; 28.2 vs. 8.6%, p = 0.001, respectively). The tubeless group had a higher proportion of 0-degree discomfort (81.5 vs. 30.8%, p = 0.001) and shorter duration of postoperative hospital stay than the control group (4.59 vs. 5.53 days, p < 0.001). No difference was observed in terms of urination retention and urinary incontinence between the tubeless group and the control group. After PSM, the advantages of the tubeless group still existed, and comparing to the partially tubeless group, the completely tubeless group was of even less UTI and more 0-degree discomfort (18.5 vs. 0.0%, p = 0.019; 96.3 vs. 59.3%, p = 0.002). The tubeless protocol was the only independent protective factor of urinary complications. A nomogram was constructed and showed good predictive ability. Conclusions: The tubeless catheterization protocol led to fewer complications, better compliance, and shorter hospital length of stay. The advantages were more significant with the completely tubeless protocol. The utility of our nomogram can assist clinicians in avoiding risks in performing the tubeless protocol.

show abstract

Section: Discussionmentioning

confidence: 99%

A Novel Tubeless Urinary Catheter Protocol Enhanced Recovery After Minimally Invasive Lung Surgery

et al. 2020

View full text Add to dashboard Cite

show abstract

“…The standard Foley catheter does not have any features that safeguard against CAUI and instead possesses inherent design flaws that predispose to CAUI. In particular, it has been demonstrated that the retention balloon of contemporary Foley catheters can generate enormous inflation pressures (>700 kPa), which far exceed the pressure required to rupture human cadaveric urethras (>150 kPa) . Research has been undertaken to develop safety mechanisms to prevent CAUI due to balloon inflation injuries.…”

Section: Cauimentioning

confidence: 99%

“…Attempted balloon inflation within the urethra generates a high pressure that activates the TUCCS valve to decant fluid from the catheter system, thus preventing balloon inflation in the incorrect position. In a pilot study of 100 male patients requiring urethral catheterisation, the TUCCS valve was used by 34 clinicians and activated in 7% of patients . Safe Medical Designs, Inc. (San Francisco, CA, USA) has incorporated a second ‘pilot balloon’ in the external portion of its patented Signal Catheter™ .…”

Section: Cauimentioning

confidence: 99%

Innovations in indwelling urethral catheterisation

Jeffery

Mundy

2020

BJU International

View full text Add to dashboard Cite

The indwelling urethral catheter remains an integral part of contemporary medical care, despite its significant design shortcomings. Urethral catheterisation is responsible for wellrecognised complications including catheter-associated urinary tract infection (CAUTI), catheter-associated urethral injury (CAUI), catheter blockage, and bladder mucosal irritation. In this narrative review, we provide an update on current innovations in urethral catheter design, aimed at safeguarding against these complications. There is an obvious need to improve catheter technology and urologists should support the translation of innovations into clinical practice. Keywordsindwelling urethral catheter, catheter-associated UTI, catheterassociated urethral injury, medical device innovation, catheter blockage

show abstract

“…In these 7 cases, the catheter was successfully manipulated into the urinary bladder and inflated. 2 The transurethral catheter safety valve (Class Medical Ltd, Annacotty, County Limerick, Ireland) is a single-use device consisting of a flow restrictor and a pressure valve. (Figure 1) The red tab is pulled before using the safety valve.…”

Section: Introductionmentioning

confidence: 99%

Possible Use of a Safety-Valve with a Foley Catheter During Catheterisation of Male Spinal Cord Injury Patients for Prevention of Urethral Trauma Caused by Inflation of the Catheter Balloon in the Urethra

Vaidyanathan¹,

Soni²

2023

MDER

View full text Add to dashboard Cite

We used a safety-valve (Trans-Urethral Catheterisation Safety Valve, Class Medical, Limerick, Ireland) to prevent urethral trauma due to inflation of the anchoring balloon in the urethra during catheterisation of male spinal cord injury patients in a spinal unit. The safety-valve is attached to the balloon channel of a Foley catheter. If the balloon is inflated when it is in the urethra, the pressure valve is activated. Any fluid pushed into the balloon channel leaks out and balloon inflation stops, indicating that the balloon is not inside the bladder. The safety-valve was used in 44 catheterisations. There was leakage of water during three catheterisations. In the first case, the health professional did not inflate and deflate the balloon prior to its use. This "pre-valve inflation" step overcomes the baseline resistance pressure of the balloon and prevents fluid leaking from the valve when the catheter is in the correct position. In the second instance, the valve was found to be defective. In the third case, the catheter had been misplaced; it was removed and repositioned; there was no leakage of water during inflation of the balloon. In one out of 44 catheterisations, the catheter had been misplaced; leakage of water from the safety-valve stopped inflation of the balloon and prevented iatrogenic urethral trauma. The safety-valve may be used during catheterisation of male patients in the spinal unit to prevent urethral trauma caused by inflation of the balloon of Foley catheter in the urethra. However, health professionals should remember the few shortcomings of the catheter safetyvalve.

show abstract

Clinical Evaluation of a Safety-device to Prevent Urinary Catheter Inflation Related Injuries

Abstract: The safety-valve device piloted in this clinical study offers an effective solution for preventing catheter balloon inflation related urethral injuries.

Cited by 12 publications

References 15 publications

A Novel Tubeless Urinary Catheter Protocol Enhanced Recovery After Minimally Invasive Lung Surgery

A Novel Tubeless Urinary Catheter Protocol Enhanced Recovery After Minimally Invasive Lung Surgery

Innovations in indwelling urethral catheterisation

Possible Use of a Safety-Valve with a Foley Catheter During Catheterisation of Male Spinal Cord Injury Patients for Prevention of Urethral Trauma Caused by Inflation of the Catheter Balloon in the Urethra

Contact Info

Product

Resources

About