BROOKFIELD, Wis., March 1, 2012 /PRNewswire/ — 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.
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 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 www.incontrolmedical.com.
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.