FDA OKs Renovia’s leva Digital Therapeutic for Fecal Incontinence

Renovia, a developer of non-surgical treatments for female pelvic floor disorders has earned U.S. Food and Drug Administration (FDA) clearance for its leva pelvic health system as a first-line treatment for chronic fecal incontinence (FI) in women.
 
leva was granted FDA breakthrough status in 2021 and had previously been FDA-cleared to treat stress, mixed, and mild-to-moderate urinary incontinence (UI) in women.
 
Traditional first-line treatment for FI includes dietary changes, over-the-counter antidiarrheal medications and rectal biofeedback devices.
 
leva helps women strengthen pelvic floor muscles, including the puborectalis, which acts as a “sling” around the rectum and vagina and contributes directly to FI. The prescription digital therapeutic (PDT) guides woman through pelvic floor muscle training (PFMT) via a small vaginal motion sensor and smartphone app. It requires five minutes of training a day.
 
“I’ve spent over 20 years studying the causes and treatments for fecal incontinence,” Holly E. Richter, Ph.D., MD, Professor and The Endowed Chair in Obstetrics and Gynecology at the University of Alabama at Birmingham, (UAB) and Associate Director, Gynecologic Research in the UAB Center for Women’s Reproductive Health told the press. “First-line treatment alternatives have been limited in the past so it’s important that clinicians can now consider leva as a new treatment option that is supported by robust clinical data.”
 
“In my clinical practice, accidental bowel leakage is among the conditions that has the most negative effect on patients’ emotional well-being,” said Roger R. Dmochowski, MD, MMHC, Professor of Urology and Surgery and Associate Surgeon-in-Chief at Vanderbilt University Medical Center. “Fewer than 30% of women seek care for FI, suggesting the depth of embarrassment and shame patients experience. My hope is that better first-line treatment options, like leva, will lead more women to seek care. The ability of a single noninvasive therapy to treat both conditions is really very helpful to our patients. Now with FDA approval, patients will have much improved ability to use this efficacious therapy on a long-term basis, which is most beneficial for them.”
 
“We’re gratified that the FDA has cleared this new indication for the leva Pelvic Health System as we now have a tremendous opportunity to treat a condition that’s been cloaked in silence for too long.,” said Renovia’s CEO Eileen Maus. “leva’s popularity among women with urinary incontinence already made it a great choice for providers, particularly OB/GYNs, who are at the frontlines of women’s care. leva enables discreet, at-home, non-surgical, drug-free symptom relief, which we believe positions it to dramatically improve women’s access to improved first-line care.”