DENVER - Analytica on Wednesday announced that the U.S. Food and Drug Administration has approved the PeriCoach at-home pelvic floor trainer device and smartphone app as an over-the-counter treatment for mild, moderate and stress urinary incontinence and urge incontinence.
Pelvic floor muscle exercise is recommended as first line non-pharmacologic treatment for the millions of women – estimated at one in three – who suffer from urinary incontinence.
A strong pelvic floor is also associated with improved sexual function and satisfaction.
"Women can use pelvic floor exercises or 'Kegels' to reduce or eliminate symptoms, and home training with PeriCoach, now available OTC, just got a lot more convenient," stated Leslie Rickey, associate professor of urology and of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine. "It is critical that women put their trust in new technology for pelvic floor muscle training that has been medically tested and FDA-cleared, as these products have an internal component and are designed to treat a real medical condition."
"This approval will bring PeriCoach, and the confidence that comes with it, to women in a convenient way," said Geoff Daly, CEO Analytica. "The OTC approval is also a significant milestone for our company in the U.S. We are committed to offering as many women as possible a simple, effective way to deal with a condition that is common but not normal. Over the counter availability of PeriCoach may mean the difference between a day lost to worrying about leaking, and a day confident in enjoying favorite activities."