FDA approves urinary incontinence device as OTC

BROOKFIELD, Wis. — The Food and Drug Administration on Monday cleared InControl Medical's ApexM for over-the-counter sale to treat stress, urge and mixed urinary incontinence in women.

 

The ApexM provides muscle stimulation through a customizable probe to strengthen the pelvic floor and calms spasms of the bladder muscle, decreasing urgency. ApexM is one of only three devices available for the treatment of urinary incontinence in women. The others — also manufactured by InControl Medical — require prescriptions.

 

ApexM will retail for a suggested $299, the company reported.

 

"ApexM should be the first line of treatment for women with urinary incontinence," said Herschel Peddicord, president of InControl Medical. "This product is highly efficacious, simple to use and by far the least expensive treatment available for female urinary incontinence."

 

Stress incontinence occurs when a woman laughs, sneezes, coughs or exercises. Urge incontinence is characterized by the constant urge to use the bathroom. Mixed incontinence is a combination of both. ApexM treats all three conditions, rendering expensive urodynamic testing to diagnose the type of incontinence unnecessary.

 

According to the National Association for Continence, up to 40 million women in America have experienced bladder leakage issues at some point in their lives. A study shows almost half of new mothers experience incontinence following normal delivery and about one in six following cesarean section. Up to two-thirds of women who "leak" have never mentioned it to their physicians and just as many do not use any treatment or product to manage their bladder leakage.