In an ideal world no one would have a catheter, but the reality is that 100M patients worldwide rely on an indwelling urinary catheter and they are badly served by the ubiquitous Foley design.

Catheterized patients often experience problems, such as catheter-associated urinary tract infections (CAUTI), catheter blockages, leaking and bladder spasms [Wilde et al. 2016]. CAUTI are the most frequent nosocomial infections [Jacobsen et al., 2008].

Many conventional measures don’t capture the full scale of the problem.

• Most focus on infections acquired during hospital stay; The U.S. Centre for Disease Control & Prevention notes that Urinary Tract Infections (UTI’s) are the most common type of healthcare-associated infection. It also notes that among UTIs acquired in the hospital, approximately 75% are associated with a urinary catheter.

• But the reported incidence of infections acquired during hospital can be relatively low; Using the specific CDC definition for CAUTI, many institutions record a rate of less than 3 CAUTI per 1,000 catheter days which suggests the chance of infection from short term placement (2-3 days) would be relatively low - perhaps less than 0.5%.

• Infections may become apparent only after the patient leaves hospital; The U.S. National Surgical Quality Improvement Program (NSQIP) captures 30-day postoperative complications, including UTI’s (using a similar ‘tight’ definition as CDC). Using the example of Nephrectomy, where a catheter would routinely be placed for a few days as part of the procedure - the overall rate of infection was 1.7% with the majority occurring post discharge, on average 13 days post operation.

• Tracking patient reported symptoms and treatment over time highlights much higher levels of incidence; Saint et al 2018, tracked infectious and non-infectious complications amongst over 2,000 patients for 30 days post short term placement. Infection was determined by either patients being told they had urinary tract infections or a positive report of symptoms (fever, chills, dysuria, etc) requiring the patients to see a physician. This noted a much higher level of CAUTI (10%) and even higher levels of non-infectious complications.

Consistent with high incidence of issues noted by more than 120 Community nurses caring for 2,500+ catheter patients... [FLUME online questionnaire, 2018]

• Infection; 48% of Foley users have been prescribed antibiotics for catheter associated urinary tract infections

• Blockage; 45% block within 4 weeks, 65% within 8 weeks and 90% within 12 weeks

• Leakage; 46% of patients suffer 'bypassing' (leakage) 

Consistent with high CAUTI rates noted in major study by Pickard et al (2012)

This study also involved tracking complications in over 2,000 patients after short term catheter placement - in this case for 6 weeks. While they observed no significant difference in the rates of CAUTI between a silver coated and standard catheter, the rates of CAUTI based on diagnosis/ treatment with antibiotics were significant at 12.5%.

Amazing video reveals the source of the problem...

Professor Roger Feneley devoted his entire career to urology and catheter related problems in particular. Below, are excerpts from a video that clearly highlights several deficiencies of the Foley design,

1. with the soft bladder mucosa collapsing onto the hard tip of the catheter and even being drawn into the drainage eyes,

2. being torn away as the bladder refills

3. the tip impaled in the bladder wall and being twisted and removed

FLUME estimates the healthcare burden of complications associated with Foley catheter usage to be equivalent to $80 on average, for each of the 28m placed annually in the US - a total burden of around $2.2bn - and close to $60 even for short term placement.

• A 2009 CDC report estimated the direct costs of healthcare associated infections in U.S. hospitals and included CAUTI’s at around $0.4bn, based on an estimate of 450k infections and a cost per CAUTI of between $867 and $1,002.

• The estimate of $1k per CAUTI has been questioned, however. In a 2018 study published in the American Journal of Infection Control, Hollenbeak and Schilling noted “We can conclude that the prevailing notion of a CAUTI costing approximately $1,000 is an underestimate and an oversimplification of its true economic burden” - up to $10k for for inpatient cost to Medicare for ICU patients.

• The most significant cost, however, appears to flow from infections arising outside of a hospital setting and then resulting in unscheduled hospital admissions. Janet Colli and others in their 2014 study of trends in hospitalisation from indwelling catheter complications (2001-2010) estimated a cost from unscheduled admissions of $1.3bn - that alone is equivalent to close to $50 for every one of the 28m Foley catheters placed annually in the U.S. (TMR Market estimate)

• FLUME estimates that the total annual burden associated with Foley catheter complications in the U.S. is equivalent to $80 on average, $2.2bn in total - and $60 even for short term placement.

References

Wilde MH, McMahon JM, Crean HF, & Brasch J (2016). Exploring relationships of catheter-associated
urinary tract infection and blockage in people with long-term indwelling urinary catheters. J Clin
Nurs. doi: 10.1111/jocn.13626.

Jacobsen SM, Stickler DJ, Mobley HLT, Shirtliff ME (2008). Complicated Catheter-Associated Urinary
Tract Infections Due to Escherichia coli and Proteus mirabilis. Clin Microbiol Rev; 21(1), 26-59.

Saint, Krein, Hollingsworth, Trautner, and Lescinkas, A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. Published July 2018

Pickard et al Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial; (2012)

The Direct Medical costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention; Author – R. Douglas Scott II, Economist Division of Healthcare Quality Promotion National Center for Preparedness, Detection, and Control of Infectious Diseases Coordinating Center for Infectious Diseases Centers for Disease Control and Prevention March 2009

Hollenbeak CS, Schilling AL. The attributable cost of catheter-associated urinary tract infections in the United States: A systematic review. Am J Infect Control. 2018 Jul;46(7):751-757. doi: 10.1016/j.ajic.2018.01.015. Epub 2018 Feb 22. PMID: 29478760.

Colli J, Tojuola B, Patterson AL, Ledbetter C, Wake RW. National trends in hospitalization from indwelling urinary catheter complications, 2001-2010. Int Urol Nephrol. 2014 Feb;46(2):303-8. doi: 10.1007/s11255-013-0524-x. Epub 2013 Aug 10. PMID: 23934618.)

TMR Indwelling Catheters Market Global Industry Analysis, Size, Share, Trends, and Forecast, 2018-2030