BLYH Products will provide an external urinary catheter for women with urinary incontinence. Its use circumvents the risk of infection associated with indwelling catheterization of the urinary tract. The unique design of the device makes it conform to the individual wearer so that it does not have to be custom made. It is simple to apply and does not hinder the wearer from sitting, standing, or other activity.The present catheter design is a modification of the prototype invented in 1982. The catheter is applied to the periurethral tissues by an adhesive similar to that used in ostomy products. A second piece of the same adhesive applied to the external aspects of the labia minora stabilizes the device. Urine flows out through tubing to a collection bag. The catheter thus constitutes a noninvasive method of closed system urinary drainage.The immediate goal of Phase I is to assess the design in a series of 50 intensive care patients. Refinements will be made as needed to optimize ease of application, conformability to the individual patient, and leak-free collection of urine. In Phase II, the rate of urinary tract infection among patients wearing the device will be compared to that of patients with indwelling catheters.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
