Virtual Research Organisation (VRO) ObvioHealth may have completed the first ever fully virtual urogynaecology study, in the form of a medical device clinical trial of Renovia’s digital intravaginal device Leva for female stress urinary incontinence.

Urinary incontinence is unintentional passing of urine, which affects one in four women, particularly 75% of women above the age 65 reporting urine leakage. Pelvic floor muscle training (PMFT), commonly known as Kegels, is the standard among noninvasive approaches for urinary incontinence. However, 75% of women perform the exercises incorrectly by engaging wrong muscle groups or following a wrong routine. Leva is designed to help users how to preform Kegels more effectively.

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In the medical device trial, Leva monitored the contractions of the pelvic floor muscles while subjects were completing at-home PMFT. The wand-like device collected data and wirelessly transferred it to a smartphone app downloaded at the start of the study.

Pandemic triggered virtual approach

ObvioHealth monitored the compliance of the participants and solved technical issues patients encountered while using the device. The trial had a 93.5% electronic Patient Reported Outcomes (ePRO) rate.

The added stress of the Covid-19 pandemic and difficulties to recruit women for studies encouraged Renovia to investigate a virtual design, said vice president of clinical operations Robin Sutherland. The trial was conducted from September 2020 to March 2021.

ObvioHealth partnered patient recruitment provider 1nHealth to execute digital recruitment, with the study being fully recruited in under 14 weeks. The companies used only social media to find participants which cut the cost of traditional recruitment.

Here at Clinical Trials Arena, we have been paying close attention to the rise of decentralised clinical trials, with our own exclusive analysis revealing an increase in uptake over the past two years. Specifically on remote monitoring in clinical trials, we observed there’s been a steady increase in uptake in drug studies from 2015, with a noticeable jump last year. Our analysis also found that ePRO use increased in the past year particularly in women’s health trials.