New smart electronic implant stops urine loss

UAntwerp and UZA have joined forces with the University of Oxford to tackle urinary incontinence in women. Electrodes are implanted next to the pudendal nerve with minimal surgery, giving patients back control of their bladders. The initial results are very promising.

For many people, holding in their urine is no easy feat. International studies show that about a third to half of all adult suffer women from some form of urine loss. Only a small percentage of them seek and receive treatment. The two most common forms of involuntary urine loss are stress incontinence (e.g. when coughing, or when lifting heavy objects), and urge incontinence (a sudden and compelling urge to urinate that cannot be stopped).

'Depending on the type of urinary incontinence, there are several treatments available today that involve implants,' says Prof. Stefan De Wachter, who works as a urologist at UZA and UAntwerp. 'However, these treatments usually only target certain specific symptoms. They don't evolve with the symptoms, so over time, patients tend to experience urine loss again. Other solutions only target the bladder, while the sphincter also needs to be stimulated to prevent urine leakage.'

UAntwerp, UZA and the University of Oxford together created a spinout called Amber Therapeutics, which developed Amber-UI: the first 'smart' neurostimulator that stimulates the pudendal nerve to help patients 'hold it in'. The implant can sense and interpret signals from the patient's body and adjust its stimulation accordingly to restore normal bladder function in different circumstances.

A minimally invasive procedure

De Wachter: 'We stimulate the pudendal nerve, the nerve that causes the sphincter to close and allows us to hold our urine. This allows us to reinforce existing physiological reflexes whenever needed. With this new form of stimulation that adapts to the signals it receives from the patient's body, we've managed to treat the two most common forms of urinary incontinence. It causes the bladder to relax when the patient experiences an urge to urinate, and it causes the sphincter to close in order to prevent stress incontinence. We've developed a new surgical technique to implant the system that requires only three small incisions in the skin.'

Promising results

The partners initiated a pilot study called AURA-2 (Augmenting Urinary Reflex Activity). Fifteen women will get the implant and the procedure will be done at UZA. Three of them already have the implant. 'The other participants will undergo surgery in the coming months,' De Wachter said. 'The initial findings are positive, both in terms of the feasibility of the surgical procedure and the therapy.'

Aidan Crawley, CEO of Amber, is excited to add: 'We developed this treatment in less than two years. It shows our ability to rapidly prototype new bioelectrical therapy concepts. What's fantastic is that our initial results show that our treatment could potentially have a major impact on the lives of many patients suffering from urinary incontinence. For so many of them, there's no effective therapy today. Amber-UI can really make a difference in their lives.'

Amber Therapeutics received seed funding for its development work to advance Amber-UI into the AURA-2 clinical study from Oxford Science Enterprises, 8VC and a UKRI Biomedical Catalyst grant.

For the AURA-2 study, Amber has partnered with Bioinduction Limited (Bristol, UK) for use of its Picostim DyNeuMo Research Platform, developed in collaboration with the University of Oxford, which leverages Bioinduction’s core Picostim Deep Brain Stimulation (DBS) System.   

About urinary incontinence and the current neuromodulation market

Urinary incontinence (UI) is a debilitating medical condition that affects many millions of people globally. It can cause falls and fractures, hospitalisations, and can bring about a sense of loss of control and shame, leading to isolation and depression. Many patients do not actively seek treatment, with symptoms of UI found in 40 million Americans but only 16 million currently receive any form of therapy.

It is estimated that 6.8 million Americans are eligible for the existing sacral neuromodulation therapy, which is still highly underpenetrated (around 50 thousands implants a year) and only treats urge incontinence. Mixed urinary incontinence is more than three times more common than urge incontinence, but until now there is not a single treatment available on the market or in development.

About Amber Therapeutics

Amber Therapeutics develops next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system. Amber’s approach leverages closed-loop intelligence to create ‘synthetic reflex arcs’ that can sense, interpret, adapt and respond to a patient’s individual signals, thereby restoring normal physiological function.

Amber Therapeutics was founded by a multidisciplinary team of clinicians, translational neuro-engineers, med-tech industry professionals and experienced entrepreneurs focused on developing transformational therapy innovations for major unmet medical conditions. The company was spun out from the University of Oxford in 2021 and is backed by Oxford Science Enterprises and 8VC.