Avation Medical has announced positive results from the multi-centre trial of Vivally, its medical device to treat overactive bladder (OAB) syndrome.
The FREEOAB multi-centre study enrolled 96 patients with an OAB. Results showed that there were significant reductions in daily void, incontinence, and urgency episodes at 12 weeks, which contributes to enhanced quality of life. These positive effects persisted over the long term, with continued improvement in diary parameters observed at 12 months.
The non-invasive, bladder-control therapy device and mobile application are intended to treat patients with urinary urgency and urge urinary incontinence (UUI) caused by OAB syndrome.
The safety and efficacy results have been published in Urology, a peer-reviewed journal for urologists.
FREEOAB study’s principal investigator Colin Goudelocke said: “The Vivally system represents a significant advancement in bladder control therapy as a non-invasive, patient-centred therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs.”
The Vivally System helps avoid surgery, drugs, or needle-electrodes. According to the press release, it is the only approved closed-loop and non-invasive neuromodulation system for bladder control in the US.
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The closed-loop system uses the patient’s own physiologic response to confirm activation of the tibial nerve. The system enables the delivery of an electrical signal to the patient’s tibial nerve via an ankle-worn garment, blocking electric signals along nerves to the brain that encode urinary urges.
The device received approval from the US Food and Drug Administration (FDA) in April 2023.
Smart devices such as Vivally are helping to tackle incontinence. In August 2023, BlueWind secured FDA de novo status for its urinary incontinence device Revi, a neuromodulation implant that is placed on a patient’s ankle to stimulate the tibial nerve.