Device to lessen incontinence - Food and Drug Administration approves Miniguard disposable foam pad for women - Brief Article

FDA Consumer, Sept, 1996

A disposable foam pad about the size of a quarter was cleared by FDA as a device to help prevent urinary leakage in women with urinary stress incontinence. It is available by prescription only.

The Miniguard is a triangle-shaped pad with adhesive coating on one side, which the woman places over her urinary opening, where it forms a seal.

Urinary stress incontinence is a condition in which urine leaks as a result of physical stress, such as coughing, laughing, or lifting heavy objects. The condition affects about 10 million people, mostly women.

Although the Miniguard does not stop leakage, it lessens its frequency. In a study of 356 women, the average participant improved from about 14 leaks a week without the device to about five leaks a week with it. Women with severe stress incontinence, who had about 34 episodes of leakage a week, had only 10 leaks a week with the device. When urine leaked in these women, the amount was smaller.

Because leaks are possible, women using the Miniguard need to wear panty liners or pads for additional protection.

The device can be worn two to five hours at a time during the day and throughout the night. When a woman needs to urinate, she peels the pad off and discards it. After urinating, she puts on a new pad. The Miniguard may be worn during exercise, although vigorous activity, such as running, may move it out of position.

The product is not for women with urinary tract or vaginal infections or local irritations. Also, it is not as effective in women who have had surgery for their incontinence.

The Miniguard is made by Advanced Surgical Intervention, of Dana Point, Calif.