["Flowsecure" artificial urinary sphincter: a new adjustable artificial urinary sphincter concept with conditional...

To spread de concept of a new artificial urinary sphincter with conditional occlusion for stress incontinence. The new prototype was conceived and designed in The Institute of Urology and Nephrology of London by Professor Craggs M. and Professor Mundy A.R.

The FlowSecure sphincter consists of an adjustable pressure-regulating balloon, a stress relief reservoir, a control pump and valve assembly unit with self-sealing port and a urethral cuff. The pressure regulating balloon determinates de operating pressure of the device; the pressure is adjustable in the range 0-80 cm H2O and can be altered by injection or removal of normal saline through the self sealing port. The stress relief balloon transmits transient intrabdominal pressure to the cuff during periods of stress. An adjustable circular urethral cuff minimises creasing and possible stress fractures.

The device is implanted as a one-piece assembly which is pre-filled with sterile saline. The surgical technique is simple and associated with little handling, reducing risk of infection and potential assembly errors. The adjustable pressure regulating balloon in association with the stress relief reservoir enables the cuff occluding pressure to be set at a low range, therefore reducing the risk for atrophy and erosion.

The new FlowSecure urinary artificial sphincter with conditional occlusion is designed to provide good continence rates adjusting regulating pressures when needed and conceived to reduce the risk of potential complications associated with excessive occluding pressures and mechanical failures.