First Report

U.S. Patient and Clinician Experiences With the inFlow™ Urinary Prosthesis for Permanent Urinary Retention in Women

Leanne Schimke, MSN, FNP-C, CRNP, CUNP; Kevin M. Connolly


Urol Nurs. 2020;40(2):61-73. 

In This Article

Limitations of Current Medical Treatment Options

Urology clinicians are aware that urinary catheters are an imperfect solution and may result in a variety of problems, including infection, encrustation, and a decrease in quality of life.


Catheter-associated urinary tract infections (CAUTIs) are common, but their full impact is not always well understood, even by many clinicians (Saint et al., 2008). The Centers for Disease Control and Prevention (CDC) estimates that annually, CAUTIs cause over 13,000 deaths and add $1.85 billion in direct medical costs within U.S. hospitals alone (Klevens et al., 2007). These estimates are notable for their limited scope because they only include women with indwelling catheters, do not include community-dwelling catheter users or those in assisted living/long-term care facilities, and are based on the most recent year with completed data – but that year is 2002. In a worrisome trend, the risk from UTIs is increasing with the emergence of resistant bacteria (Köves et al., 2017). Bactericidal coatings have been employed in attempts to improve the infection resistance of urinary catheters, for example, silver alloy and antimicrobial catheters coated with nitrofurazone-releasing, minocycline, and rifampin; however, such attempts have only been modestly successful (if at all), and even then, only when in use for less than two weeks (Newman, 2017; Pickard et al., 2012; Stickler, 2008). It is predicted that UTI-related mortality will continue to increase (CDC, 2009), and at least for the moment, it appears as if the most effective treatment for infection is still prevention.


Encrustation (Figure 1) and blockage of indwelling urinary catheters is a commonly encountered clinical problem. Approximately 50% of all patients who use indwelling catheters on a long-term basis experience problems with blockage due to encrustation (Getliffe, 2002). This is distressing to patients because it can result in urine leakage around the catheter, urinary retention, and pain upon removal of the catheter (a procedure that can also result in urethral trauma). Unfortunately, this problem has proven difficult to resolve; as Stickler (2014) states, all types of urinary catheters are susceptible to encrustation and to date no effective methods of prevention have emerged.

Figure 1.

Catheter with Encrustation

Decreased Quality of Life

Chronic catheterization can be psychologically devastating. The ability to void is a basic daily function, and the loss of this ability erodes one's self-image as an independent individual. Furthermore, PUR often occurs in those who are already fragile. In essence, they must either self-catheterize – a procedure so burdensome that long-term compliance is low (Afsar et al., 2013; Crescenze et al., 2019; Girotti et al., 2011), or use an indwelling catheter and urine bag, which many regard as an end-stage development and the end of their social lives. Interestingly, according to Welk (2017), a better quality of life is not consistently demonstrated in the literature among women using intermittent catheterization versus indwelling catheters, despite the lower morbidity and clear consensus from providers that CIC is the gold standard for neurogenic bladder drainage.

In addition to the "big three" problems of infections, encrustation, and decreased quality of life, Robinson (2004) noted and Saint (2018) concurred that urinary catheter use is associated with a variety of complications, including hematuria, pain, leakage, bladder spasm, bladder calculi, bladder neck erosion (patulous urethra), and genitourinary injury, which includes traumatic injury to the urethra, bladder, and surrounding structure during catheter insertion or removal. Long-term use of indwelling urinary catheters also has a 16- to 20-fold increase in the risk of squamous cell bladder cancer (Caruso et al., 2017).

Finally, catheter use also has a significant environmental impact. In the United States, Medicare Local Coverage Determination: Urological Supplies (L33803) reimburses up to 200 intermittent catheters per month – or 2,400 catheters per patient each year (2019), leading to a large volume of medical waste. Clearly, the clinical armamentarium for PUR could benefit from some new additions.