Atlantic Therapeutics‘ Innovo shorts beat intravaginal probe devices at keeping women with stress urinary incontinence dry in an FDA-designed clinical trial.
An externally worn electrical muscle stimulation device, Innovo demonstrated greatly reduced risk of infection and improved user tolerability over the intravaginal devices, according to research presented this week at the International Continence Society meeting in Philadelphia.
Innovo works by non-invasively strengthening the pelvic floor via pain-free muscle stimulation, according to a company statement. The garment wraps around the thighs and is attached to a hand-held controller that varies the intensity of the pelvic floor stimulations to treats stress, urge and mixed incontinence. The at-home treatment is suitable for women and men and is clinically proven to work for 93% of users experiencing a significant reduction in leaks after four weeks, the company said.
At week twelve of the trial, 87.2% of the Innovo group and 86.8% of the control group in the study were in the dry or mild categories of stress incontinence severity, representing an improvement of 32.7% for Innovo and 26.1% for the control group. The Innovo group reported no infections, compared with the control group, which had an infection rate of 7.7%. Compliance with treatment also appeared to be better with Innovo, the study said.
A quarter to a third of adults in the U.S. suffer from urinary incontinence, according to the Urology Care Foundation. Standard treatment options begin with physical therapy. If physical therapy is not successful, pelvic floor stimulation devices may be used before escalation to the use of injectable bulking agents or surgical interventions involving an implanted mesh sling. Market research performed for Atlantic Therapeutics revealed that 77% of people had never heard of or tried external electrical stimulation devices.
Galway, Ireland-based Atlantic Therapeutics has CE Mark approval for Innovo in Europe and is seeking de novo clearance for the device from the FDA.