The Centers for Disease Control and Prevention reports by 2030, approximately 20% of the United States’ population will be 65 years or older. This age range is associated with higher rates of chronic and debilitating health issues frequently requiring measures to address subsequent urinary incontinence for immobile or otherwise inhibited patients. As over 80% of hospital-acquired urinary tract infections (UTIs) are associated with indwelling urinary catheters, catheter-associated UTIs (CAUTIs) are the most frequent hospital-associated infections in the United States.
CAUTIs can lead to serious medical complications, including bacterial colonization, bladder stones, recurrent and chronic infections, and septicemia. While long-term catheter use can cause damage to the kidneys, bladder, and urethra, as well as contribute to the development of antibiotic resistance. Numerous studies over the past several decades have detailed efforts to reduce CAUTIs using a variety of approaches and protocols, such as educational programs and behavioral daily protocol checklists, antimicrobial catheters, biofilm, and measures to improve urinary retention in males. Clinicians, caregivers, and patients need a safer and cost-effective alternative when indwelling catheters may be convenient, but not medically necessary or advisable.
To address these issues and the gap in product availability, the Georgia-based small business, Zackcup® LLC, has developed a distinct alternative to indwelling catheters for male patients. The mission of the clinical trial is to demonstrate that the Zackcup®, also called the Zcup, has the same benefits as other external catheters, along with the ability to avoid the possible negative outcomes from using these products. Specifically, the Zackcup® urinal is waterproof and breathable, prohibiting compression of the penile shaft and allowing it to stay dry. Additionally, the product is much easier to manage, making it possible for the patient or caretaker to apply the Zcup and dispose of it after use. This innovative solution helps circumvent problems such as skin infections, irritation, hypersensitivity, and addresses patients’ mental well-being and comfort.
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