Green Journal publishes study showing leva "significantly improved" symptoms of urinary incontinence in women versus Kegel exercises alone

BOSTON, March 11, 2022 /PRNewswire/ -- Renovia Inc. ("Renovia"), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that Obstetrics & Gynecology (The Green Journal), published a prospective randomized controlled superiority trial (RCT) showing that pelvic floor muscle training (PFMT) using the leva® Pelvic Health System was statistically and clinically superior to Kegels alone for improving symptoms of stress and stress-dominant mixed urinary incontinence (UI) in women. The study is the first RCT demonstrating the superiority of a digital therapeutic device over Kegels-alone to treat UI.

According to a recently published prevalence study, UI affects 62% of U.S. adult women. PFMT, commonly practiced via Kegel exercises, is first-line treatment for UI. However, only 25% of women who perform Kegels do so effectively, limiting the potential positive impact on UI symptoms. In the study, "Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial," women who used leva to guide PFMT achieved significantly improved UI symptoms and a reduction of UI episodes compared with women who followed a Kegels-alone program of written and verbal instructions.  

"78 million American women experience UI, and this number is expected to continue increasing," said Milena M. Weinstein, MD one of the study's principal investigators and Female Pelvic Medicine and Reconstructive Surgery Fellowship program director and Co-Chair, Center for Pelvic Floor Disorders, Massachusetts General Hospital, and Associate Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. "UI can have serious emotional and physical repercussions, which is why new strategies for delivering effective treatment to women are essential. This study suggests digital health, particularly tools that keep clinicians involved in patient care, could play a valuable role by expanding treatment access to a larger group of women and—equally important—actively supporting their success."

leva is an FDA-cleared, prescription digital therapeutic (PDT) that combines a small vaginal motion sensor with a smartphone app, offering an easy, non-invasive, drug-free way for women to effectively strengthen their pelvic floor muscles to improve UI symptoms. leva requires just five minutes of practice a day, which women can do at home, on their own schedule. leva's ability to support remote care and provide adherence monitoring enabled the study to be designed, commenced, and completed during the COVID-19 pandemic. The study included world-class research institutions, but its remote format avoided the need for in-person office visits, allowing the research team to attract women across a wide age range, and who were racially and geographically diverse, to participate.

"Multiple studies show that pelvic floor muscle training can offer effective, first-line treatment for urinary incontinence," said Holly E. Richter PhD, MD, a principal investigator for the study, Professor and Endowed Chair of Obstetrics and Gynecology at the University of Alabama at Birmingham. "This study demonstrated the efficacy and safety of leva, a motion-based digital therapeutic device that guides pelvic floor muscle training - with the women in the leva group achieving superior improvements in stress and stress-dominant mixed urinary incontinence. Significantly, the leva device could make first-line therapy more accessible by offering a new opportunity for obstetrician-gynecologists to monitor and engage with women to support their success with first-line treatment."

The study enrolled 363 patients, who received care remotely from four research sites: Massachusetts General Hospital/Harvard Medical School, University of New Mexico, Southern California Permanente Medical Group and University of Alabama at Birmingham. Findings from the study include the following:

• leva users experienced superior symptom improvements in stress UI and stress-dominant mixed UI, compared with those in the Kegels-only control arm at eight weeks. In fact, participants in the leva group saw significant improvement in UI symptoms as early as four weeks into treatment.
• leva users saw their leakage episodes decrease from almost two leaks per day to only one leak every three days.
• A significantly greater number of women in the leva group reported they were "much improved" or "very much improved" on the Patient Global Impression of Improvement scale.
• Adherence was high, nearly 70% (equivalent to approximately two times per day) among leva users at the end of the 8-week study.

"UI can have serious emotional and physical repercussions, which is why a randomized controlled superiority trial supporting leva's efficacy as a treatment is significant," said Mandy Pulliam, MD, Renovia's Chief Medical Officer. "Clinicians need a convenient, effective way to treat a large group of women. In the absence of supervised care, women may embark on an unsupervised pelvic floor training program, which often has limited efficacy. leva could play a valuable role not only in supporting effective treatment but also in helping clinicians reach more patients and support their success."

"UI is not a normal part of aging, and women deserve better than a lifetime of adult diapers and pads," said Eileen Maus, CEO of Renovia. "Prescription digital therapeutics like leva offer a novel way for women and their clinicians to work together to make first-line UI treatment both successful and accessible. As the prevalence of UI continues to increase, this randomized controlled trial—a first-of-its-kind for a digital therapeutic for UI—shows leva can help clinicians reach more of the 78 million women experiencing bladder leaks and demonstrated the power and promise of remotely conducted clinical trials in medical research. It's timely that March is Women's History Month. We call on women and their clinicians to help #MakeUIHistory so that more women can live leak-free."

Obstetrics and Gynecology posted the study online on March 10, 2022. It will appear in the April 2022 print edition.

About the leva® Pelvic Health System
The leva Pelvic Health System offers a novel, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI). Combining a small FDA-cleared vaginal motion sensor connected to a smartphone app, leva offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active physician involvement, all of which support women's success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, leva is available by prescription only, allowing physicians the opportunity to treat UI on a broad scale and with ongoing involvement in patient success. leva is the first femtech product included in the Digital Therapeutics Alliance product library and has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI. Renovia's clinical study work with leva received the 2021 Medical Device Network Excellence Award for Research and Development.

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® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI), an underreported condition experienced by over 78 million women in the U.S. alone. Renovia's technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information about Renovia or leva please visit www.renoviainc.com and www.levatherapy.com and follow us on Twitter, Facebook, LinkedIn and Instagram.

Important Indication and Other Information for the leva Pelvic Health System
The leva Pelvic Health System 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 System is by prescription and is not for everyone. Please talk to your prescriber to see if leva is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use leva 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 System, see its Instructions for Use available at www.renoviainc.com and www.levatherapy.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 Inc.