Evaluation of a new external condom catheter system.

The purpose of this study was to perform a biomechanical performance study and a clinical trial on a new external condom catheter system. The biomechanical performance study demonstrated that the vented connector failed following exposure to urine for 14 days. In addition, angulation of the inlet adapter of anti-reflux valve of the urinary leg bag to an angle of 35 degrees (+/-5 degrees) caused complete obstruction of urinary flow. A clinical trial of the new condom catheter with its inner flap revealed twisting of the catheter that interrupted urinary flow in four of ten patients. This catheter twisting was not observed in condom catheters without inner flaps. Furthermore, this new system is not easily applied or removed by patients with neurosensory deficits or musculoskeletal weakness. Design modifications of the vent within the connection tubing, the anti-reflux valve in the collection bag, the condom catheter with its inner flap, as well as the leg bag attachments should remarkably improve the performance of this new urinary drainage system.