FDA okays OTC use of Innovo for stress incontinence

March 25, 2020 0 By FM

The US FDA has granted over the counter (OTC) clearance to Innovo, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI), Atlantic Therapeutics announced. 

The device was previously available in the US by prescription.

Innovo is a transcutaneous muscle electrical stimulator that uses Multipath technology to target the weakened pelvic floor muscles. Women with stress urinary incontinence are recommended to use the device for 30 minutes a day, five days a week for three months. 

They can then follow a maintenance routine of one to two 30-minute sessions per week to maintain pelvic floor strength. 

It delivers 180 perfect and complete pelvic floor contractions, equivalent to Kegel exercises, during each 30-minute session. With every gentle pulse, a woman feels her pelvic floor muscles lifting and releasing – strengthening and rebuilding the muscles and helping regain bladder control one session at a time.

Results of a clinical study demonstrated that 80% of Innovo users experienced significant improvements after four weeks, and 87% were considered “dry” or “near dry” after three months.