The First-Ever Fully Virtual Clinical Trial in Urogynecology
ObvioHealth and Renovia conducted a groundbreaking study on the efficacy of an at-home medical device for the treatment of stress and mixed urinary incontinence. Read more below to understand how we delivered a successful, fully virtual clinical trial in the midst of the pandemic.
Challenge
Before the pandemic, Renovia planned to conduct a 15-site study. But, in response to worldwide shutdowns and increased personal health awareness, they recognized that their target cohort—older female patients—may be too COVID-conscious to attend in-person visits. These new limitations prompted Renovia to investigate remote options.
There had never been a fully virtual study conducted in the urogynecology space. Renovia was navigating unknown territory in uncertain times. This clinical trial needed:
1. The ability to ensure safety and monitor for adverse events (AEs)
2. Patient training for both the treatment and control arms
3. Coordination between the CRO and academic partners
4. Reliable methods to recruit and retain a notoriously busy and hard-to-reach patient population
Solution
ObvioHealth designed a fully virtual, randomized controlled clinical trial and managed the trial process from start to finish.
Recruitment
ObvioHealth deployed a digital recruitment strategy using targeted advertising on social media. Creative assets were designed to appeal to women in specific age groups, decreasing cost per click.
Patient Training
Patients were trained on how to use the device using three different methods: a video, a pamphlet, and three phone calls. The phone conversations ensured patients were using the device correctly and allowed them the opportunity to ask questions.
Keep Patients Engaged
ObvioHealth’s virtual site team—referred to as our COACH (Clinical Oversight and Coordination Hub) team—was available to provide support to patients at all times via live chat in the ObvioHealth app. The COACH team monitored adherence, answered questions about the trial, and offered tech support.
Coordinating Multiple Stakeholders
Renovia stakeholders included multiple academic institution partners, as well as Mass General who acted as the principal investigator (PI). ObvioHealth arranged a 15-minute daily meeting to ensure all stakeholders were updated on the progress of the study and to discuss any urgent issues.
Data Capture
Patients used the ObvioHealth app to record each bladder leak incident and trips to the bathroom. Patients input these outcomes in real time, increasing the accuracy of the data and reducing recall bias. The app also prompted patients to report changes in health status to help the clinician team to promptly identify AEs.
Results
The study delivered statistically significant results for the device versus control group for two primary outcomes. The results of the study were published in ACOG’s Obstetrics and Gynecology.
Recruitment
350 Patients in 14 weeks
10x Lower costs ($67 per patient)
Retention & Compliance
89% Retention
93.5% ePRO Compliance
Study Diversity
22% Patients above 65 years (Oldest patient was 82)
Testimonial
We knew we needed to make the study easy for our patients. We had the added stress of launching this trial at the height of the pandemic. 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
SVP of Clinical Operations at Renovia
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