FDA approves InTone (InControl Medical) for female Urinary Incontinence

The FDA has cleared InTone, a medical device from InControl Medical, to treat female Urinary Incontinence. 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.