Axonics, California, USA, has announced that a study, named ARTISAN, looking at its implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has provided some strong results for the Axonics r-SNM System.
The study was published in the journal of Neuromodulation: Technology at the Neural Interface in October 2020. The ARTISAN study was led by Stefan De Wachter, Antwerp University Hospital, Edegem, Belgium, and Katleen Jottard, Brugmann University Hospital, Brussels, Belgium. There were 15 subjects with faecal incontinence in this study who were each implanted with the Axonics r-SNM System in a single procedure.
The key findings of the study were that 87% of all implanted patents were therapy responders based on an equal to or greater than 50% reduction in faecal incontinence episodes as documented in their bowel diary; of that 87%, 92% were responding to the therapy six months post-implant; and finally weekly faecal incontinence episodes were decreased from a median of eight at the baseline, to a median of one and half after six months of therapy, meaning a 79% reduction in weekly faecal incontinence episodes. There were no unanticipated device or procedure related adverse events.
Additionally, ARTISAN found that after six month 93% of patients indicated that charging the Axonics device was both ‘easy’ and ‘acceptable’.
Karen Noblett, chief medical officer of Axonics and board-certified urogynecologist, commented, “faecal incontinence is a physically and psychologically debilitating condition for patients who often suffer in silence due to embarrassment. The strong outcomes of this study are consistent with Axonics’ pivotal study, ARTISAN, in which urinary incontinence patients who also had faecal incontinence experienced significant reductions in FI symptoms and meaningful improvements in quality of life. Axonics congratulates and thanks the study investigators for continuing to expand the body of clinical evidence for bowel dysfunction.”
According to Axonics, there are an estimated 87 million adults affected by overactive bladder across the USA and Europe, and an estimated 40 million adults are reported to suffer from faecal incontinence and/or accidental bowel leakage. Axonics claims these conditions are caused by a miscommunication between the bladder and the brain.