Advanced Surgical Wins FDA Approval for Incontinence Pad
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DANA POINT — Advanced Surgical Intervention received Food and Drug Administration approval for a new prescription urinary incontinence pad for women.
The disposable pad, about the size of a quarter, has an adhesive coating that is placed over the urethra to form a seal and stop urine from leaking. Although not always effective, it should help women who leak urine after physical stress such as coughing, laughing or lifting heavy objects, the FDA said.
About 10 million Americans--mainly older women--have urinary incontinence.
The FDA based its approval of the pad, called the Miniguard, on a 12-week clinical trial involving 356 women. The Miniguard helped women decrease the number of urinary leakages to five episodes per week from 14, the FDA said. For those with severe stress incontinence, the pad reduced the number to 10 per week from 34 a week.
It isn’t as effective for women who had surgery for incontinence and shouldn’t be used by those with urinary tract or vaginal infections.