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March 17, 2022

Renovia, ObvioHealth conclude fully virtual medical device trial in urogynaecology

The medical device study investigated Renovia’s Leva, designed to help users perform Kegels more effectively.

By Urtė Fultinavičiūtė

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.

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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.

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.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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