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FDA Clears Female Incontinence Device–Therapy for Bladder Leakage To Build Up Pelvic Muscle Tone for Greater Control

Posted Mar 12 2012 3:58am

We are definitely seeing some very new innovative devices on the market being approved by the FDA and this one costs around $600 and you need a prescription from your doctor to get one, and he/she has to program it for you as it collects data and monitors your progress…this thing could have some side benefits when you think about it:)  The FDA kind of took care of the men first of course in this area as last summer we had this approved and it also needs a prescription.  image

You can watch the video below and hear about how it works and it sounds like it has potential and if it works versus taking pills, then it’s a good deal for sure.  Here’s the “talk to your doctor” page at the site for more information.  It operates similar to a tens unit. 

“Once the prescription is received you will see your physician or medical provider to personalize the device for your treatment needs.  Once InTone has been set up by your provider you can begin your home program to cure your unwanted bladder leakage or incontinence.  Follow up visits with your doctor are recommended to review data and revise treatment settings.  The frequency of these visits will be directed by your provider, however at least one follow up per month for the first 3 months is recommended”.

The device talks to you and records all the data and measures the changes in muscle control as it delivers a micro-current to the pelvic floor.  One size fits all as it inflates when inside.  The product even has a guarantee that if conditions do not improve you can get most of your money back and of course the data will tell them whether or not it was used regularly and the numbers.  Each session lasts just 10 minutes a day and again maybe some nice side effects possible <grin>.  Hey you have to have a little humor once in a while.  BD  

Press Release:

(Brookfield, WISCONSIN) – The Food and Drug Administration (FDA) has cleared InTone™, a medical device, to treat female urinary incontinence.

“InTone is a true medical breakthrough, and welcome news for the millions of women who have incontinence issues,” said Herschel “Buzz” Peddicord, president & CEO of InControl Medical, LLC, and inventor of InTone. “With InTone, we believe we can effectively treat this condition in most cases.”

Urinary incontinence, or unwanted bladder leakage, affects up to 30 million American women. Stress incontinence is unwanted bladder leakage that can occur after coughing, sneezing, laughing, or exercise, and urge incontinence is a strong, sudden need to urinate due to bladder spasms or contractions. In most cases the root cause of incontinence is poor muscle tone in the pelvic floor muscles. It can be caused by childbirth, trauma, excessive exercise, lack of exercise and other factors. image

InTone is the first medical device that combines mild micro-current stimulation (similar to a TENS unit), exercises and guided biofeedback to strengthen the muscles in the pelvic floor.

After prescribing InTone, the physician customizes the settings for InTone and the patient is shown how to use it at home. A sensor in the unit measures pressure to determine if the patient is doing the exercises properly. The biofeedback unit uses voice-guided instruction to take her through the routine and reports her muscle isolation and strength. Each daily session takes about ten minutes, and data from each session is recorded. After two weeks or so, the physician analyzes the recorded data and adjusts InTone based on the patient’s progress, and at-home treatment sessions continue. Most patients should experience progress in a few weeks, and most patients should experience effective relief in 90 days.

Many women with urinary incontinence endure it in silence. Absorbent pads and diapers do nothing to treat the condition. Medications, if image prescribed, can cause side effects and are not always effective. Surgery, if performed, can be traumatic and painful, and is not always effective. Research has shown that even when properly taught how to perform pelvic floor, or Kegel, exercises, about half of all women do them incorrectly.

InTone is now available by prescription to patients in the United States. More information on InTone can be found at .

InTone was developed by InControl Medical, LLC, an FDA-listed company based in Brookfield, Wisconsin providing specialty medical products for women’s health, and is sourced and manufactured entirely in the United States.

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