New Device Limits Female Incontinence

The Food and Drug Administration has approved new help for the millions of women who suffer incontinence.

The Reliance Urinary Control Insert, a tamponlike device that forms a plug to block urine leakage, completely blocks urine leaks 80 percent of the time, according to its manufacturer, UroMed Corp. of Needham, Mass.

Some 5 million U.S. women experience urine leaks during physical stress, such as coughing or lifting heavy objects. Most susceptible are pregnant or elderly women.

Sufferers could try exercising, which cures about 10-20 percent of incontinence, or surgery, which carries risks but leaves up to 85 percent of patients dry, said Dr. David Staskin of Harvard Medical School.

Others simply wear absorbent pads or diapers, or try an adhesive-backed foam the FDA approved in May to temporarily seal over a woman’s urethra. On Friday, the agency approved the UroMed product.

Reliance will be in pharmacies before January, but a price has not been set. A doctor must prescribe Reliance and train women to insert it into the urethra with a special syringe that blows up a balloon on its tip to form a plug.

The FDA warned that Reliance is not risk-free, saying some 44 percent of women will develop a urinary tract infection within the first year of use. In 6 percent, the device moves from the urethra into the bladder. And 78 percent of women will experience some discomfort or irritation.