Obvio Health Concludes Virtual Urogynecology Clinical Trial

Obvio Health and Renovia recently completed the first fully virtual urogynecology clinical trial, which validated the efficacy of Renovia's leva Pelvic Health System on women's urinary incontinence (UI). 

The clinical trial randomized 350 women into control and treatment arms. All women participated from the comfort of their homes and were not required to visit the site. Patients used ObvioHealth's app to capture real-time data on bladder leads, reducing recall bias while increasing 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.  

In the trial, patient's' UI symptoms and reduction of UI episodes improved compared with a home training program.  

Specifically, a significantly greater number of participants using the leva Pelvic Health System reported they "much improved" or "very much improved" on the Patient Global Impression of Improvement (44.1%) than in the control group (28.8%).  

Overall, the trial had a 94.5% electronic patient-reported outcomes (ePRO) compliance rate. 

"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," Ivan Jarry, CEO of ObvioHealth, said in the announcement.  

UI affects as many as 50% of women throughout their lifetime. Prevalence estimates rise with each decade of life, and symptom severity and related quality of life tend to worsen over time. Pelvic floor muscle training represents first-line conservative treatment for UI, including stress urinary incontinence (SUI), urgency UI, and mixed UI subtypes. 

ObvioHealth and partner 1nHealth designed a digital recruitment strategy using creative assets to appeal to women in various age groups. This study was fully recruited via social media in under 14 weeks at a cost per participant more than 10 times lower than typical studies.  

"We knew we needed to make the study easy for our patients. This encouraged us to investigate a virtual design. 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," Robin Sutherland, vice president of human resources and clinical operations at Renovia, said in the announcement.