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.”
For more information about ObvioHealth, visit www.obviohealth.com. 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.