A new intraurethral sphincter prosthesis with a self contained urinary pump.

ABSTRACT

An intraurethral sphincter prosthesis with a self contained urinary pump for the management of atonic bladder in women was developed and tested. The prosthesis is comprised of a short, self retaining silicone catheter in which there is a valve and pump. Available in a range of lengths and diameters according to urethral size, its insertion is similar to that of a urethral catheter. The prosthesis is secured by a novel fixation method that has soft expandable silicone fins at the bladder neck and a flexible flange at the external meatus. It is activated by a small hand-held control device. To urinate, the activator is placed on the lower abdomen area and the "on" button is pressed, providing energy to the pump by a magnetic coupling method. Once activated, the valve opens and the pump rotates at a high speed, drawing urine from the bladder and pushing it forward, allowing the patient to "void" with a urine flow of 10 to 12 cc/sec. When the bladder is completely evacuated, the pumping ceases and the valve closes, restoring continence. The device was evaluated clinically in 17 women. Fifteen of the patients had a range of use of 2 weeks to 16 months during which they were dry and had complete bladder emptying. Two patients did not tolerate the device because of uninhibited detrusor contractions and, in both cases, it was removed without complication after 5 days.