Six-Center Study Will Compare Renovia’s Pelvic Digital Therapeutic System to Standard of Care Pelvic Floor Muscle Exercises in Home-based Treatment of Stress-dominant Urinary Incontinence
Boston, MA – November 12, 2018 – Renovia Inc. (“Renovia”), a company dedicated to discovering and delivering first-line digital therapeutic and diagnostic devices for women with pelvic floor disorders, today announced it has launched a large, multi-center randomized controlled trial (RCT) to study the efficacy of a first-line non-surgical digital therapeutic for the treatment of stress-dominant urinary incontinence (UI).
Pelvic floor muscle exercises (PFME), also known as Kegel exercises, are the widely accepted first-line conservative treatment for pelvic floor disorders including stress, urgency, and mixed UI within the urogynecology, urology and physical therapy communities. However, many women have trouble identifying and contracting the correct muscles when performing these exercises, and remembering to perform the exercises regularly can be challenging.
Renovia’s next-generation leva® Pelvic Digital Therapeutic System is an innovative device allowing women to have real-time visual verification they are performing their PFME correctly and consistently by guiding women through pelvic floor muscle treatment. The study seeks to determine whether home use of Renovia’s next-generation leva device (i) leads to more significant improvements in pelvic floor muscle performance than a PFME program without leva® and (ii) improves adherence to a long-term maintenance program of home PFME.
“The REDUCE study will allow Renovia’s digital therapeutic and diagnostic devices to undergo a clinical trial involving six world class academic medical centers,” said Samantha Pulliam, MD, Chief Medical Officer at Renovia. “I couldn’t be happier with the slate of hospitals and practitioners who have agreed to participate in the study. Their rigor will help us as we look to transform the standard of care for UI and other pelvic floor disorders.”
Urinary incontinence affects an estimated 20 million women in the U.S.[i] and an estimated 250 million women worldwide.[ii] Urinary incontinence can have a negative impact on quality of life and lead to potentially severe medical conditions. Despite its prevalence and adverse effects on women’s health, urinary incontinence is often underreported by women and thus not addressed by clinicians. However, early intervention has been shown to resolve or reduce symptoms, improve immediate and long-term condition-specific quality of life, and limit the need for more invasive and costly treatments.
Jessica McKinney, PT, Renovia’s Vice President of Medical Affairs and Clinical Advocacy, added, “There is a gap between symptomatic UI and access to care, as well as a gap between the usual standard of care and the gold standard for non-surgical UI care – i.e., pelvic floor physical therapy. With REDUCE, we hope to take a significant step toward providing new treatment alternatives to help close these gaps for the millions of women affected by UI.”
Through its proprietary technology and app-enabled visualization of pelvic movement, Renovia is developing a product pipeline with the potential to better diagnose and treat women affected by urinary incontinence and other pelvic floor disorders. Renovia’s existing FDA-cleared device, the leva® Pelvic Digital Health System, is indicated for strengthening pelvic floor muscles, and indicated for treating stress, mixed and mild to moderate urgency urinary incontinence in women. The leva System and Renovia’s full product pipeline all leverage state-of-the-art patient-based apps and data management technology to provide precise, cost-effective treatment of weakened pelvic floor muscles in real-time, while collecting actionable compliance and progress data on women’s pelvic health.
The Randomized Efficacy study using Digital system for Urinary incontinence Compared with an Exercise program (REDUCE), will include women with stress UI or stress-dominant mixed UI. Subjects will be randomized to eight weeks of PFME treatment using the leva System or eight weeks of standard of care home PFME treatment (i.e., without leva). Subjects in the leva arm will perform guided PFME for 2.5 minutes twice daily. Subjects in the non-leva arm will perform home-based PFME three times daily. Following eight weeks, subjects from the leva arm will be further randomized to either receive automated reminders for the remainder of one year, or receive no additional reminders.
Renovia was formed to develop and commercialize products for better first-line diagnosis and treatment to improve the condition-specific quality of life for millions of women with pelvic floor disorders. Renovia’s technology enables treatment via precise visualization of pelvic movement in real time during pelvic floor muscle training, while monitoring usage and progress over time. As a women’s health organization, Renovia is in pursuit of scalable and cost-effective care for pelvic floor disorders delivered through the power of digital health. For more information, please visit here.
Jim Barron/Chris Kittredge/Tori Goodell
Sard Verbinnen & Co.
[i] Wu, J. M., Hundley, A. F., Fulton, R. G., & Myers, E. R. (2009). Forecasting the Prevalence of Pelvic Floor Disorders in U.S. Women. Obstetrics & Gynecology, 114(6), 1278–1283.
[ii] Irwin D.E., Kopp Z.S., Agatep B., Milsom I., & Abrams P. (2011). Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction in British Journal of Urology, 108(7):1132-8.