A wearable device to treat stress urinary incontinence, Innovo®, has been granted over-the-counter clearance by the Food and Drug Administration.
Innovo is a transcutaneous muscle electrical stimulator that targets weakened pelvic floor muscles. The device, which was previously only available with a prescription, is used for 30 minutes a day, 5 days a week for 3 months, after which users can follow a maintenance routine of one to two 30 minute sessions per week.
“In the privacy of their own home, women can simply pull on a pair of shorts for a 30-minute Innovo® pelvic floor workout,” said Ruth M. Maher, PhD, DPT, co-inventor of Innovo and Professor, Department of Physical Therapy, Philadelphia College of Osteopathic Medicine (PCOM) Georgia. “By strengthening and re-educating their pelvic floor muscles, they have the opportunity to live a leak-free life in as little as 3 months.”
A randomized controlled trial comparing Innovo with an FDA-approved intravaginal device found that the neuromuscular external electrical stimulation device was associated with significant improvement in stress urinary incontinence measures. However, it was not found to be noninferior to the intravaginal device.
With regard to safety, the Innovo treatment group reported fewer urinary tract infections compared with the intravaginal device group. Overall, study authors concluded that it was a “low-risk alternative to intravaginal devices.”
The retail price for the device is $449.95 and it is not covered by insurance.
For more information visit myinnovo.com.