FDA approves device for treatment of female incontinence

March 14, 2012

The FDA recently approved the InTone device (InControl Medical, LLC, Brookfield, WI) to treat female urinary incontinence.

The FDA recently approved the InTone device (InControl Medical, LLC, Brookfield, WI) to treat female urinary incontinence.

The product combines mild micro-current stimulation, exercises, and guided biofeedback to strengthen the muscles in the pelvic floor.

After prescribing InTone, the physician customizes the settings for the device and the patient is shown how to use it at home. A sensor in the unit measures pressure to determine whether 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 10 minutes, and data from each session are recorded, according to the company. After approximately 2 weeks, 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, the company said.

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