Case Study: Renovia achieves statistically significant device efficacy and high retention in a fully virtual urogynecology trial with ObvioHealth

The First-Ever Fully Virtual Clinical Trial in Urogynecology

Renovia, a digital therapeutics company whose leva device is an FDA‑cleared prescription product for pelvic floor training, faced a major challenge when the COVID‑19 pandemic made its planned 15‑site, in‑person study impractical. Concerned that an older, COVID‑conscious patient cohort would avoid clinic visits, Renovia needed a way to ensure safety monitoring, patient training, multi‑stakeholder coordination, and reliable recruitment/retention for the first fully virtual urogynecology trial.

ObvioHealth designed and managed a fully virtual randomized controlled trial using targeted social media recruitment, multi‑modal patient training (video, pamphlet, and phone coaching), a 24/7 virtual COACH support team, and an app for real‑time ePRO data capture and AE monitoring. The ObvioHealth solution enrolled 350 patients in 14 weeks, achieved statistically significant primary outcomes published in ACOG’s Obstetrics and Gynecology, delivered 93.5% ePRO compliance, 89% retention, 22% of participants over 65 (oldest 82), and reduced recruitment costs ~10x to $67 per patient.

Renovia

Robin Sutherland

‍SVP of Clinical Operations