Device Cleared for Female Urinary Incontinence

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The FDA has cleared InTone, a medical device for treating female urinary incontinence.

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

After prescribing InTone, physicians customize settings for InTone and patients are 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 are recorded. 

After two weeks or so, the physician analyzes the recorded data and adjusts InTone based on patients' 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, according to a press release issued by InControl Medical of Brookfield, Wisc., the maker of the device.

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