New FDA-approved Catheter Innovation

• 15 – 25% of patients admitted to Hospital are catheterized ⁸.
• ca. 50,000 residents of long-term care facilities have a permanent urinary catheter requiring regular change ⁸.
• Foley catheters form about 70% of the market and in the United States about 30 million Foley catheters were sold in 2017 ⁴.
• Urinary catheters are placed most frequently in Emergency Rooms (54%) ⁹
• Prevalence in ICU settings: ca. 60% in the United States, 75% in Taiwan and 76% in Japan ⁹

During their hospital stay, up to 25% of patients require a urethral catheter, with approximately 0.3% sustaining urethral trauma from the insertion of the Foley catheter.

The incidence of catheterization-associated urethral injury (CAUI) is:

• 0.7 /1,000 adult male hospital admissions ²
• 3.2 – 13.4/1,000 men who need a catheter ² ³ 
• 9.5% of men undergoing cardiac surgery ⁴

Complications from CAUI include:

• • 81% sustain Clavien-Dindo grade 2 or greater complication ⁷, among which:
    • 40% develop urosepsis ⁷
    • 5% die from complications related to  urosepsis ³
    • 78% suffer from long-term urethral stricture ³

• The cost to treat CAUI is about $10.000 per case, which amounts to $371,790 (€335,377 ) over 6-month at two teaching hospitals ⁷, with an extrapolated healthcare burden of $2 billion dollars per year in the US ⁷.
• Additional costs to manage long-term complications of urethral strictures ⁷
• Potential medico-legal costs ¹⁰

• Across a single hospital, 81% of men were successfully catheterised with the Urethrotech UCD® after failed standard Foley-catheterisation ¹¹
• CAUI in men undergoing Cardiac Surgery may be preventable with the Urethrotech UCD® ⁴
• Urology Nurses can solve difficult catheterisation independently and avoid patient care delay ¹²

Utilisation and success rate of Urethrotech UCD® in a 530-bedded Community Hospital ¹¹:

• Managing failed standard catheterisation with the Urethrotech UCD® was time and cost effective and resulted in successful urethral catheter placement in 81% of patients.
• In 4 men, mild urethral bleeding was recorded as the result of standard Foley-catheterisation that did not interfere with UCD-catheterisation.
• All staff were highly satisfied with the new device and would use it again as the next step to solve difficult urethral catheterisation.

[1] Urethrotech UCD for difficult or failed catheterisation. Medtech innovation briefing. Published: 7 August 2017. Available from: nice.org.uk/guidance/mib116

[2] Kashefi C, Messer K, Barden R, Sexton C, Parsons JK. Incidence and prevention of iatrogenic urethral injuries. J Urol 2008;179(6):2254–22.

[3] Davis NF, Bhatt NR, MacCraith E, Flood H, Mooney R, Leonard G, Walsh MT. Long-term outcomes of urethral catheterisation injuries: a prospective multi-institutional study. World J Urol. 2020;38(2):473–480.

[4] Bugeja S, Mistry K, Yim IHW, Tamimi A, Roberts N, Mundy AR. A new urethral catheterisation device (UCD) to manage difficult urethral catheterisation.World J Urol. 2019;37(4):595-600.

[5] Thomas AZ, Giri SK, Meagher D, Creagh T. Avoidable iatrogenic complications of urethral catheterisation and inadequate intern training in a tertiary-care teaching hospital. BJU Int 2009; 104(8):1109–1112.

[6] Bacsu C, Van Zyl S, Rourke KF. A prospective analysis of consultation for difficult urinary catheter insertion at tertiary care centres in Northern Alberta. Can Urol Assoc J 2013; 7(9–10):343–347.

[7] Davis NF, Quinlan MR, Bhatt NR, Browne C, MacCraith E, Manecksha R, Walsh MT, Thornhill JA, Mulvin D. Incidence, cost, complications and clinical outcomes of iatrogenic urethral catheterization injuries: a prospective multi-institutional study. J Urol. 2016;196(5):1473-1477.

[8] Guideline for Prevention of Catheter-Associated Urinary Tract Infections (2009). Available from: https://www.cdc.gov/

[9] Kuriyama A, Takada T, Irie H, Sakuraya M, Katayama K, Kawakami D, Iwasaki H, Fowler K, Tokuda Y, Saint S. Prevalence and Appropriateness of Urinary Catheters in Japanese Intensive Care Units: Results From a Multicenter Point Prevalence Study. CID 2017; 64 (2): S127–S130.

[10] Awad MA, Ostenberg EC, Chang H, Gaither TW, Alwaal A, Fox R, Breyer BN. Urethral catheters and medical malpractice: a legal database review from 1965 to 2015. Transl Androl Urol 2016; 5(5):762–773.

[11] Fluckiger S, John H. A new Urethral Catheterisation Device for safe urethral catheterisation in difficult cases. J Clin Urol. 2019;12(83).

[12] Dragova M, Bamfo A, Holmes K, Attard K, Frost A, Mundy A. Managing difficult catheterisation in nurse-led catheterisation services: Does guidewire-assisted urethral catheterisation make a difference? Int J Urol Nurs. 2020;1–7.