Published study supports the potential of leva® Pelvic Health System to improve symptoms of faecal incontinence

Innovative treatment for urinary incontinence in women may provide effective, non-surgical treatment for accidental leaky gut

BOSTON, December 21, 2021 / PRNewswire / – Renovia Inc. (“Renovia”), a women-run company that develops digital therapies 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 the use of got up® Pelvic Health System may be effective in treating symptoms of fecal incontinence (FI) in women. Currently approved for the treatment of female urinary incontinence (UTI), got up could offer a treatment option for women with IU, FI, or both if cleared by the United States Food and Drug Administration (FDA). Renovia has received revolutionary device designation from the FDA for got up as a first-line treatment for chronic fecal incontinence in patients with October 2021.

Renovia Inc. is a female-run company that develops digital therapies for female pelvic floor disorders

Commonly known as accidental leaky bowel, FI refers to the involuntary loss of stool. The isolating and embarrassing condition affects around 9% of women, a conservative estimate, as less 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 got up on symptoms of IF and disease-specific quality of life for 27 women. At the end of the 10-week study, participants reported a “significant improvement in the severity and quality of life specific to the symptoms of IF,” of which about half achieved a 50% reduction in episodes. of IF. The researchers shared the early findings at the American College of Obstetricians and Gynecologists (ACOG) annual clinical and scientific meetings on April 30-May 2, 2021.

“Although small, our pilot study demonstrated the feasibility of a new treatment option for women with IF, which we desperately need,” said Holly E. Richter, PhD, MD, principal investigator, professor and holder of the chair in obstetrics and gynecology of the University of Alabama at Birmingham, (UAB) and Associate Director, Gynecological Research at the UAB Center for Women’s Reproductive Health. “While additional research involving more women would be useful in examining the effectiveness of the intervention, these results show that vaginal biofeedback devices like got up can significantly alleviate the symptoms of IF. Given its established therapeutic value for UI, this could be a solution of unique value for women living with both UI and IF, a particularly impactful situation. “

There are few treatment options for accidental leaky gut. PFMT is a first-line treatment, but existing supportive devices rely on anal feedback (usually electrical stimulation). got up helps women strengthen their pelvic floor using vaginal biofeedback and without electrical stimulation, which may be more tolerable and thus promote adhesion. Associate a small flexible vaginal wand with a smartphone application, got up also offers women the opportunity to effectively strengthen the pelvic floor muscles at home with just five minutes of practice per day.

“There are many barriers that keep treatment for FI beyond the reach of women,” said Dr. Samantha pulliam, Medical Director of Renovia Inc. “The disappointing lack of effective first-line treatment options plays a significant role in the delay in treatment for many women. The very few options available are typically clinical, require surgery, or are undesirable due to their reliance on anal feedback. got up is a non-surgical option that relies on vaginal biofeedback, which should promote patient compliance. Using got up, women can also access first-line therapy at home, on their own schedule, without the inconvenience of the costs, travel and time associated with clinic visits. While its use to treat FI requires FDA review and clearance, these early data from studies show its valuable potential for treating several pelvic floor disorders, which could help alleviate existing treatment barriers for them. women living with UI, IF or both. “

The clinical article “Use of digital movement therapy in women with fecal incontinence: a pilot study”, published online at December 11, 2021. The print publication is expected in early 2022.

About got up® Pelvic health system
the got up Pelvic Health System offers women an innovative, non-invasive, drug-free way 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 approved vaginal wand connected to a smartphone app, got up provides accurate visualization of pelvic movement in real time, enables progress tracking and enables active physician involvement, all of which contribute to women’s success. Recognizing that level one evidence shows that training the pelvic floor muscles is most effective when done under the supervision of a qualified healthcare professional, got up is available by prescription only, allowing physicians to treat UI on a large scale and with deep involvement in patient success. got up is the first femtech product to be included in the Digital Therapeutics Alliance’s product library and has several clinical trials and published data from globally recognized medical centers supporting its efficacy in the treatment of UI.

About Renovia
BostonRenovia Inc. based is a women-run company dedicated to improving the lives of women with pelvic floor disorders. Renovia’s flagship product, the got up® Pelvic health system, offers an innovative and effective first-line treatment for urinary incontinence (UI), an underreported disease affecting 20 million women in the United States alone. Renovia’s technology enables non-invasive, drug-free treatment via precise real-time movement visualization during pelvic floor muscle training, while monitoring usage and progress. For more information on Renovia or got up please visit www.renoviainc.com and www.levatherapy.com and follow us on Twitter, Facebook, LinkedIn and Instagram.

Important notice and other information for the got up Pelvic health system
the got up Pelvic Health System is intended for strengthening pelvic floor muscles, as well as rehabilitation and training of weak pelvic floor muscles for the treatment of mild to moderate stress, mixed, and urgency urinary incontinence (including overactive bladder) in women. Treatment with got up The system is prescription and not for everyone. Please speak to your prescriber to see if got up is made for you. Your prescriber should discuss all of the potential benefits and risks with you. Do not use got up during pregnancy or if you think you may be pregnant, except with your doctor’s permission. For a complete summary of risks and instructions for got up System, see its user manual available at www.renoviainc.com and www.levatherapy.com.

Rénovia inc. and got up® are trademarks or registered trademarks of Renovia Inc. en United States and other countries. All rights reserved.

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