Medical Device Treats Female Sexual Arousal Disorder

FDA Consumer, July, 2000

A new medical device to treat female sexual arousal disorder (FSAD) has been cleared for marketing by the Food and Drug Administration. Available by prescription only, the Eros Clitoral Therapy Device consists of a small, soft, plastic vacuum cup attached by a tube to a palm-sized battery-operated vacuum pump. The cup is placed over the clitoris prior to sex and the pump draws blood into the clitoris through gentle suction, causing engorgement, which aids sexual arousal.

The device's effectiveness was studied in 25 women, 15 of whom had FSAD. Each of the women used the device during six sexual encounters. Of the 15 women with FSAD, all experienced more sensation; seven, more orgasm; 12, more satisfaction; and 11, more lubrication. Of the 10 women without FSAD, four experienced more sensation; four, more orgasm; two, more satisfaction; and three, more lubrication.

No adverse events from using the device were reported.

FSAD is a persistent or recurrent inability to attain or maintain adequate vaginal lubrication, expansion of the vagina and swelling of the external genitalia during sexual activity.

The Eros Clitoral Therapy Device is manufactured by UroMetrics, Inc., of St. Paul, Minn.