Revolutionary bioelectrical therapy has been trialled in participants requiring incontinence treatment.
Amber Therapeutics, a company spun out from the University of Oxford in 2021, applies a research system which uses ‘closed-loop neuromodulation’. This is a type of therapy which involves a device which can sense, interpret, adapt and respond to individual patient signals, which could act as an incontinence treatment.
The researchers are exploring whether technology can regulate the urge to empty the bladder (urge incontinence) and increase resistance to urine leakage caused by activities such as coughing (mixed urinary incontinence).
Picostim-DyNeuMo system can treat a range of conditions
The bioelectronic implant device is inserted in the participants’ pelvic region using a minimally invasive surgical procedure that accesses and targets the nerve that directly controls continence.
To date, five participants have been safely implanted with the system, known as Picostim-DyNeuMo, in which an adaptive algorithm is activated and runs continuously in an at-home setting. Further participants will be enrolled in early 2023.
The system was developed in a collaboration between Bioinduction Ltd, a Bristol-based bioelectronics technology company, and Professor Tim Denison, RAEng Chair in Emerging Technology at the Department of Engineering Science and Nuffield Department of Clinical Neurosciences. The tool was initially implemented as a treatment of Parkinson’s-like multiple system atrophy.
The device could treat a range of conditions beyond incontinence, including epilepsy and chronic pain. Several universities are now collaborating on applying the tool for experimental medicine.
“Modern bioelectronic systems have the unique capability to measure physiological signals and adjust stimulation in real-time. In partnership with clinicians, we can create novel adaptive, reflex-like, algorithms for exploring new therapies. The flexibility of these systems allows us to use software updates to configure different disease states. This study builds on the prior trial in Multiple System Atrophy and paves the way for emerging therapies in generalised epilepsy and chronic pain,” commented Professor Tim Denison.
Offering new hope to individuals seeking incontinence treatment
Amber therapeutics began its first-in-human study in late 2022, with plans to accelerate transformational therapy innovation for incontinence. Early evidence confirms the feasibility of the surgical procedure and therapy for future incontinence treatment, a condition that affects 8.5% of the global population.
Oxford Science Enterprises, 8VC and a UKRI Biomedical Catalyst grant provided seed funding for the development work. The funding will allow the researchers to test the safety and pilot efficacy of the incontinence treatment in 15 women. It is being carried out at the University Hospital Antwerp (Belgium).
Stefan De Wachter, Professor of Urology at Antwerp University and leading investigator for the study, said: “Most of the current available implanted therapies for incontinence are static (tapes, slings) or can only influence the bladder indirectly (such as sacral or tibial stimulation). In this trial, we stimulate the pudendal nerve, the natural pathway of continence control, and can reinforce the existing physiologic reflexes when they are needed. With our adaptive therapy, we finally have the potential to control both forms of continence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence.”
