The Virtual Research Organization Leads Women’s Health Studies to Overcome Barriers to success in underrepresented women’s disease states
NEW YORK, March 17, 2022 - ObvioHealth, a leading global Virtual Research Organization (VRO) delivering end-to-end decentralized clinical trial solutions, announces it has completed the first fully virtual urogynecology study in partnership with trial sponsor, Renovia, Inc. (Renovia). The trial validated the efficacy of Renovia’s leva® Pelvic Health System on women’s incontinence, a health concern that affects 62% of U.S. adult women.
The study included 350 women, randomized into control and treatment arms, who participated entirely from the comfort of their homes, without being required to visit a site. Patients used ObvioHealth’s app to capture real-time data on bladder leaks, reducing recall bias while increasing data accuracy. ObvioHealth’s Virtual Site team helped maintain patient retention by monitoring compliance and engaging with participants to troubleshoot tech issues, answer questions and encourage patients along the journey. The trial had a 93.5% ePRO compliance rate.
“We knew we needed to make the study easy for our patients. Women are commonly a difficult cohort to recruit due to their busy lifestyles, and we had the added stress of launching this trial at the height of the pandemic. This encouraged us to investigate a virtual design,” said Robin Sutherland, Vice President of Human Resources and Clinical Operations at Renovia. “ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.”
ObvioHealth and partner 1nHealth designed a digital recruitment strategy using creative assets to appeal to women in different age groups. The study was fully recruited via social media in just under 14 weeks at a cost per participant more than 10 times lower than typical studies.
“This research from Renovia has the potential to help millions of women,” said Ivan Jarry, CEO of ObvioHealth. “Women’s health issues are under-represented in the industry and that simply should not be the case. We have now successfully completed several decentralized trials in women’s health and have carved out an important area of expertise that we are dedicated to serving. We’ve developed best practices for digitization that we’re able to replicate in other women-focused trials, which separates ObvioHealth from other CROs in the market.”
Renovia’s leva® study was recently published in Obstetrics & Gynecology (often known as “the green journal”) and will be published in the April 2022 print edition.
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.
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.