Trial Underway Testing Bioelectronic Incontinence Device

(NIH.gov)

24 Jan. 2023. The first participants are enrolled in a clinical trial of an implanted bio-feedback device to help women control urinary incontinence, sudden or stress-related urges to urinate. The study is conducted by the start-up company Amber Therapeutics Ltd. in London, spun-off from a biomedical engineering lab at University of Oxford.

Urinary incontinence is a condition experienced often by older people, mainly women, where urine leaks accidently from the bladder. The condition results from weakened or overactive muscles around the bladder as a result of age, but can also occur from vaginal or urinary tract infections, or as an effect of Parkinson’s disease, multiple sclerosis, arthritis, or diabetes. In men, the condition can result from an enlarged prostate, or disease or injury to the prostate. Incontinence can occur as a sudden urge to urinate or from stress on the bladder from strenuous exercise, coughing, or sneezing.

Amber Therapeutics, founded in 2021, develops bioelectronic medical devices to treat disorders of the peripheral nervous system, the network of neurons carrying signals outside of the brain and spinal cord or central nervous system. The peripheral nervous system contains the autonomic nervous system that processes unconscious functions in the body, such as heart and respiratory organs, as well as sensory and muscle-movement functions.

Closed-loop device

Amber says it develops electronic devices that interact with the peripheral nervous system by sensing and interpreting nerve signals, then responding with corrective electronic signals when needed, controlled by adaptive algorithms. The company’s technology is based on research in the lab of Oxford engineering professor Tim Denison, a co-founder of Amber Therapeutics, that studies nervous system processes for the design of bioelectronic devices monitoring brain signals and regulating physiological functions.

The company’s first product, called Amber-UI, is a device to help control urinary incontinence in women, implanted with a minimally-invasive procedure. The closed-loop device, says Amber, addresses overactive bladder from both sudden urges to urinate and stress incontinence. The system has two sensing electrodes monitoring the pudendal nerve connected to an implanted pulse generator. The pudendal nerve is a major nerve pathway connecting organs and sphincter muscles in the pelvic region to the brain, including those controlling urination. The device adapts another bioelectronic device, the Picostim DyNeuMo for deep brain stimulation, developed by Bioinduction Ltd., a company also based in part on research in Denison’s lab.

The clinical trial is enrolling 15 women age 18 to 75 with urinary incontinence at University Hospital Antwerp in Belgium. The study is assessing the safety of the Amber-UI device, with the study team looking mainly for adverse effects of the implant up to a year from implantation. The team is also periodically tracking urination behavior with questionnaires and a diary, quality of life and related lifestyle factors, and technical performance of the Amber-UI device for up to six months. The company says the first three participants received their implanted devices, with the remaining 12 individuals expected to be enrolled by the end of June.

“With Amber-UI,” says Stefan De Wachter, Professor of Urology at Antwerp University, and lead investigator of the clinical trial in a company statement released through Cision, “we stimulate the pudendal nerve, the natural pathway of continence control, and can reinforce the existing physiologic reflexes when it is needed. With our Amber-UI adaptive therapy, we finally have the potential to control both forms of incontinence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence.”

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