FDA approves ApexM for over-the-counter sale

The U.S. Food and Drug Administration (FDA) has approved ApexM to be sold over the counter to treat stress, urge and mixed urinary incontinence in women.

InControl Medical LLC distributes ApexM, which provides muscle stimulation through a customizable probe to strengthen the pelvic floor and soothes spasms of the bladder muscle. ApexM is one of three devices available for the treatment of urinary incontinence in women.

Stress incontinence happens when a woman laughs, sneezes, coughs or exercises and is characterized by the persistent urge to use the bathroom. Mixed incontinence is a combination of both. ApexM treats all three conditions.

As many as 40 million women in the U.S. have experienced bladder leakage issues at some point in their lives, according to the National Association for Continence.

Until recently, the options available to women with stress, urge and mixed urinary incontinence had varied results. Absorbent pads and diapers don’t treat the condition, medications can cause side effects and are not always effective, and surgery can be painful and may not solve the problem.

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