Study shows leva® Digital Therapeutic improves fecal incontinence symptoms

BOSTON, May 25, 2021 /PRNewswire/ -- Renovia Inc. ("Renovia"), a women-led company that develops digital therapeutics for female pelvic floor disorders, today announced positive data from a pilot study to evaluate the leva^® Digital Therapeutic – a vaginally-inserted device – as an effective treatment for women with fecal incontinence (FI).  FI, commonly known as accidental bowel leakage, refers to the involuntary loss of stool – a debilitating condition affecting over 12 million women in the United States.

Conducted at The University of Alabama at Birmingham Medical Center, the 26-woman, single-arm pilot study evaluated the efficacy of the leva Digital Therapeutic for the treatment of FI in women.  The study showed significant improvement in symptoms and condition-specific quality of life for participants, with 47.6% achieving at least a 50% reduction in episodes of accidental bowel leakage. The findings of the study were presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meetings on April 30-May 2, 2021.

"Accidental bowel leakage is a sensitive topic, contributing to its vast undertreatment: fewer than 30% of women seek care despite its association with increased risk for depression, shame, guilt and social isolation. Even the mildest, most infrequent episodes of accidental bowel leakage can be emotionally devastating for a woman," said Holly E. Richter, PhD, MD, Principal Investigator, 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. "These findings provide early evidence of efficacy for a treatment that may help women who live with the daily fear of leaking stool. If cleared for this indication, the leva device would provide an easy, self-directed way for them treat their condition, in the privacy of their homes, without medication or surgery."

The leva device combines a small vaginal probe connected to a smartphone app to create a non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles. The leva Digital Therapeutic is currently FDA-cleared for strengthening a woman's pelvic floor muscles for the treatment of urinary incontinence (UI), including the symptoms of overactive bladder (OAB). Published data from globally recognized medical centers support leva's efficacy for bladder leaks as it offers a novel way to help women train and strengthen pelvic floor muscles through real-time visualization of movement when they contract the appropriate muscles. UI and FI are linked by their shared connection to pelvic floor damage as a leading cause, explaining why 20% of women with UI also suffer from FI. This pilot study data suggests leva's value also as a potential approach to treating accidental bowel leakage.  

"Stool leakage is an incredibly embarrassing condition that women are reluctant to discuss, perhaps even more so than UI," said Dr. Samantha Pulliam, Chief Medical Officer for Renovia Inc. "This keeps effective treatment out of reach for many, placing these women at greater risk for depression and other issues associated with FI. Significantly, as the U.S. population ages, the prevalence of FI is also on the rise. In fact, FI is a leading risk factor for nursing home placement. Access to a potential treatment that, when FDA-cleared, would require just five minutes a day of a woman's time in her home, while allowing her clinical team to stay involved in her progress, would be a real game-changer for a condition that's remained draped in silent shame for way too long."

The poster summarizing the study findings will be available to registered attendees of ACOG's Annual Clinical and Scientific Meetings until July 31, 2021

About Renovia
Boston-based Renovia Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Renovia's flagship product, the leva^® Digital Therapeutic, offers a novel, effective, first-line treatment for urinary incontinence (UI), an underreported condition affecting 20 million women in the U.S. alone. Renovia's technology enables non-invasive, drug-free treatment via precise visualization of pelvic movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information about Renovia or the leva Digital Therapeutic, please visit www.renoviainc.com.

Important Indication and Other Information for the leva Digital Therapeutic
The leva Digital Therapeutic is intended for strengthening of pelvic floor muscles, and rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women. Treatment with the leva Therapeutic is by prescription and is not for everyone. Please talk to your prescriber to see if the leva Therapeutic is right for you. Your prescriber should discuss all potential benefits and risks with you.  Do not use the leva Therapeutic while pregnant, or if you think you may be pregnant, unless authorized by your doctor.  For a complete summary of the risks and instructions for the leva Therapeutic, see its Instructions for Use available at www.renoviainc.com.

Renovia Inc. and leva^® are trademarks or registered trademarks of Renovia Inc. in the United States and other countries. All Rights Reserved.

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SOURCE Renovia

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