ApexM Incontinence Device Cleared By FDA For Over-The-Counter Sale | InControl Medical
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ApexM Incontinence Device Cleared By FDA For Over-The-Counter Sale

By April 13, 2015 January 15th, 2020 No Comments

BROOKFIELD, Wis., April 13, 2015 /PRNewswire/ — The Food and Drug Administration has cleared ApexM for over-the-counter sale to treat stress, urge and mixed urinary incontinence in women.

The ApexM, distributed by InControl Medical, LLC, 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 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.

Until recently, available options had mixed results. Absorbent pads and diapers do nothing to treat the condition. Medications, if prescribed, can cause side effects and are not always effective. Surgery can be traumatic and painful and may not solve the problem. Research has shown that even when properly taught how to perform pelvic floor – or Kegel – exercises, about half of all women do them incorrectly.

In all its products, InControl remains true to its philosophy that first-line treatment should focus on improving the strength and support of the pelvic floor, restoring continence naturally.

ABOUT INCONTROL MEDICAL, LLC
InControl Medical provides specialty medical products for women’s health, and is sourced and manufactured entirely in the United States. More information can be found at https://incontrolmedical.com/female-urinary-incontinence-products/

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