Dec 21, 2021, 09:00 ET
BOSTON, Dec. 21, 2021 /PRNewswire/ -- Renovia Inc. ("Renovia"), a women-led company that develops digital therapeutics for female pelvic floor disorders, today announced that Neurourology and Urodynamics, the official journal of the Society for Urodynamics & Female Urology and the International Continence Society, published a pilot study supporting that use of the leva® Pelvic Health System may be effective in treating symptoms of fecal incontinence (FI) in women. Currently cleared for the treatment of female urinary incontinence (UI), leva could offer a treatment option for women with UI, FI or both if cleared by the U.S. Food and Drug Administration (FDA). Renovia received FDA Breakthrough Device Designation for leva as first-line treatment for chronic fecal incontinence in October 2021.
Commonly called accidental bowel leakage, FI refers to the involuntary loss of stool. The isolating, embarrassing condition affects approximately 9% of women, a conservative estimate as fewer than 30% of women seek care. The prospective, single-arm, open label study examined the clinical effectiveness of pelvic floor muscle training (PFMT) assisted by leva on FI symptoms and condition-specific quality of life for 27 women. At the end of the 10-week study, participants reported a "significant improvement in FI symptom–specific severity and quality of life" with approximately half achieving a 50% reduction in FI episodes. Researchers shared initial findings at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meetings on April 30-May 2, 2021.
"While small, our pilot study demonstrated the feasibility of a new treatment option for women with FI, which we desperately need," 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. "While additional research involving more women would be valuable to examine intervention effectiveness, these results show that vaginal biofeedback devices like leva can significantly mitigate FI symptoms. Considering its established treatment value for UI, it could be a uniquely valuable solution for women living with both UI and FI, an especially impactful situation."
There are few treatment options for accidental bowel leakage. PFMT is first-line treatment, but existing supportive devices rely on anal feedback (typically electrical stimulation). leva helps women strengthen their pelvic floor using vaginal biofeedback and without electrical stimulation, which can be more tolerable and thus support adherence. Pairing a small, flexible vaginal wand with a smartphone app, leva also offers women the opportunity to strengthen pelvic floor muscles effectively at home with just five minutes of practice per day.
"There are multiple barriers that keep FI treatment out of reach for women," said Dr. Samantha Pulliam, Chief Medical Officer for Renovia Inc. "The disappointing lack of effective first-line treatment options plays a significant role in delaying treatment for many women. The very few available options are generally clinic-based, require surgery or are undesirable due to their reliance on anal feedback. leva is a non-surgical option that relies on vaginal biofeedback, which should support patient adherence. Using leva, women can also access first-line therapy at home, on their own schedule, unencumbered by the cost, travel and time associated with in-clinic visits. While its use to treat FI requires FDA review and clearance, these early study data show its valuable potential to treat multiple pelvic floor disorders, which could help alleviate existing treatment barriers for women living with UI, FI or both."
The clinical article, "Use of a motion-based digital therapeutic in women with fecal incontinence: a pilot study," published online on December 11, 2021. The print publication is expected in early 2022.
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 wand 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 deep 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.
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 affecting 20 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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