The purpose of this study was to perform a biomechanical performance s
tudy and a clinical trial on a new external condom catheter system. Th
e biomechanical performance study demonstrated that the vented connect
or failed following exposure to urine for 14 days. In addition, angula
tion 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 cetheters without inner flaps. Furthermore, this new system
is not easily applied or removed by patients with neurosensory deficit
s or musculoskeletal weakness. Design modifications of the vent within
the connection tubing, the anti-reflux valve in the collection bag, t
he condom catheter with its inner flap, as well as the leg bag attachm
ents should remarkably improve the performance of this new urinary dra
inage system.