Amber's incontinence implant shows early signs of success in first-in-human trial

Amber Therapeutics' implantable pudendal neuromodulation system so far seems safe and effective at  treating women with urinary incontinence. Preliminary data from the first-in-human study were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) annual meeting.

The University of Oxford spinout says its Amber-UI system is the first fully implantable closed-loop bioelectrical therapy being developed for urinary incontinence (UI). Amber-UI involves the implantation of two electrode leads on the pudendal nerve via a minimally invasive surgical procedure. The therapy uses a multimodal approach to directly regulate the urge to void the bladder, while also augmenting resistance to urine leakage triggered by activities such as coughing or lifting, allowing normal bladder function to be restored. 

Closed-loop approach

The AURA-2 trial, which kicked off early last year, included 13 women who had either severe refractory urge UI or mixed UI.  Of the five women with mixed UI, 80% achieved complete resolution of their incontinence episodes at six months. Clinically significant improvements in symptom-related quality-of-life were additionally seen in both groups of patients.

Meanwhile, acute stimulation had clear effects on both sphincter and pelvic floor contraction and EMG measurements, as well as on suppression of detrusor overactivity leading to increased mean bladder capacity. In patients with mixed UI, this led to reductions in both stress and urge incontinence episodes.

The study also highlighted the effectiveness of patient-controlled adaptive algorithms using Amber-UI’s integrated sensors. Physiological biomarkers indicative of pelvic neuromuscular activity were detected in real-time and categorised to execute a control policy for closed-loop stimulation, which will be used in the next trial.

In September, Amber acquired Bioinduction and its Picostim DyNeuMo neuromodulation therapy platform for an undisclosed sum.