HILTON HEAD ISLAND, S.C. - An experimental female continence control device that is placed inside the urethra can help control stress urinary incontinence without having to be removed before voiding, according to results of a pilot study presented at the annual meeting of the American Urogynecologic

Unlike urethral plugs, which control leakage but must be removed for voiding, the ContiCare female incontinence device requires no manipulation when a woman needs to urinate, explained Dr. Sharon English, principal author of the study and a urologist at Christchurch (New Zealand) Public Hospital.

Aside from urethral plugs, women with stress urinary incontinence have had only two treatment choices--pelvic floor muscle training or surgery she said at the meeting cosponsored by the American College of Obstetricians and Gynecologists.

The ContiCare device, which is made of polyurethane and silicone rubber, may be an alternative for women who have not seen improvement with exercise but remain reluctant to undergo surgery said Dr. English, who disclaimed any financial interest in the device.

Under development by ContiCare Medical Inc. based in Eden Prairie, Minn., the device is inserted into the urethra to enhance urethral coaptation, minimizing urine leakage. When the sphincter muscle relaxes during micturation, urine passes down the urethra between the urethral wall and the surface of the device. There is no urine flow through the device.

The device consists of a loop that rests inside the bladder and a straight portion that rests in the urethra. During insertion, a straightener is placed inside the device to straighten the loop and facilitate its passage through the urethra and into the bladder. The straightener is then removed, restoring the loop, which prevents the device from moving down the urethra.

The pilot study conducted by Dr. English included 20 women who had stress urinary incontinence for an average of 11 years. The women were custom-fitted for their devices, which ranged from 10 to 14 French in urethral segment diameter and from 3.5 to 4.5 cm in length.

Seven days after placement, median pad weight had decreased from 26 g to 1.8 g, and patient-voiding diaries indicated a decrease in incontinence episodes from 16 to 4 per week. Urinary flow rate decreased from 32 to 29 mL/sec, and residual urinary volume did not significantly increase, she said.

Six patients (30%) developed an infection as a result of using the device, and 7 (35%) noted discomfort.