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. The study resulted in statistically significant results, providing evidence of device efficacy. Among the many study achievements were high compliance—even among an older patient population—and lower costs.
ePRO compliance
Lower recruitment costs
Retention rate
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.
ObvioHealth designed a fully virtual, randomized controlled clinical trial and managed the trial process from start to finish.
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
Patients in 14 weeks
Lower costs
$67/Patient
Retention & Compliance
Retention
ePRO Compliance
Study Diversity
Patients above 65 years
Oldest patient was 82
“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