The newly patented Female External Catheter provides a noninvasive method of management of urinary incontinence. It was invented to offer women an alternative to indwelling catheterization and its associated risk of urinary tract infection. The present design is a modification of the prototype invented in 1982, and it has undergone preliminary clinical testing. The catheter is uniquely designed to fit the individual wearer without being custom-made. It is simple to apply and does not hinder the wearer in sitting, standing or other activity. A flanged tube is applied to the periurethral tissues by a sealing, adhesive material. A second piece of adhesive material is applied to the external aspects of the labia minora to secure the device which then requires no further support. Urine flows out through tubing to a standard collection bag. BLYH Products will continue to manufacture the catheter on a research scale from a medical-grade silicone or ethyl methacrylate, whichever proves more suitable. The immediate goal of Phase I will be to evaluate the catheter design in a series of 50 intensive care patients by criteria of leakage, skin changes, and patient comfort, as well as to acquire pilot data for the next phase. In Phase II, the rate of urinary tract infection among patients using the device will be compared to that in patients with indwelling catheters. Development of the Female External Catheter will constitute a historically overdue, major advance in the care of incontinent women.
