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New Data Demonstrates Improved Quality of Life for Women with Stress Urinary Incontinence Who Used INNOVO® Therapy Device

San Francisco, CA USA (UroToday.com) -- Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced positive quality of life data from two randomized controlled trials (RCTs) of the INNOVO® device were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting in Miami, Florida.

The data showed that INNOVO® demonstrated significant improvement in Incontinence Quality of Life (I-QOL) scores in the two trials reported. INNOVO® is a novel wearable device, that may be prescribed as a front-line therapy to those suffering stress urinary incontinence (SUI), or as a second line therapy to those that have previously failed physical therapy (in the form of supervised or unsupervised pelvic floor exercises, also known as Kegel exercises).

“Many people find that SUI gets in the way of their daily and social activities, and INNOVO® is a breakthrough treatment option that can provide relief for millions of women who are living with the burden of incontinence," said Gordie Nye, Chairman of Atlantic Therapeutics.

The first RCT, a non-inferiority trial, evaluated external versus intravaginal electrical stimulation for the treatment of SUI in 180 women. In this trial, quality of life improved in both active and comparator groups during the study and the mean changes in I-QOL score (INNOVO® 13.42) were more than double the minimal clinically importance different for this measure (6 points) after 12 weeks. In the second RCT, researchers evaluated the safety and performance of INNOVO® compared to a sham device. There was a numerical trend for a greater improvement in the INNOVO® group over the control group.

INNOVO® was approved by the United States Food and Drug Administration (FDA) on November 13, 2018 and is the first ever transcutaneous electrical stimulator cleared by the FDA, offering US women a safe, clinically effective and non-invasive choice to treat stress urinary incontinence. In its pivotal multi-center randomized controlled clinical trial, 87% of INNOVO® users were dry or almost dry after a 12-week treatment period, with 80% of patients experiencing improvement in just 4 weeks.

Using a hand-held controller that is attached to a wearable pair of shorts, INNOVO® delivers 180 perfectly targeted impulses in every 30-minute session to strengthen the muscles of the entire pelvic floor and re-educate the muscles that control bladder function. For best results, it is recommended that patients use INNOVO® for 30 minutes, 5 days a week for 12 weeks. INNOVO® has an excellent safety record to date, with over 1.8 million therapy sessions delivered by INNOVO® in Europe and no reported device related complications.