Two-year results of Axonics’ ARTISAN-sacral neuromodulation (SNM) study demonstrate that patients implanted with the r-SNM system continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life.
The pivotal study was designed to evaluate the safety and efficacy of Axonics’ r-SNM system. According to the company, at two years, 88% of all implanted patients were therapy responders, consistent with the 89% therapy responder rate reported at one-year. Eighty per cent of patients achieved >75% improvement, with 37% being completely dry. The press release also reports that there were no serious adverse or unanticipated device-related events.
“The responder rate from the ARTISAN-SNM study continues to be the highest success rate reported in SNM literature and confirms sustained efficacy,” said Karen Noblett, a urogynecologist and chief medical officer of Axonics. “Americans with urgency incontinence are undertreated and struggle to find long-term relief. The persistent robust response and patient satisfaction with the Axonics r-SNM system demonstrates that there is an easy to use, highly efficacious treatment available to those suffering from this condition.”
The ARTISAN-SNM study is a 129-patient single-arm, prospective, multicentre, unblinded pivotal clinical study. The study was conducted in 14 centres in the USA and five centres in Western Europe. All patients diagnosed with urinary urge incontinence were implanted with a tined lead and the Axonics miniaturised rechargeable neurostimulator in a non-staged procedure. Efficacy data was collected using a three-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a subject satisfaction questionnaire. Therapy responders at follow-up were identified as patients with at least a 50% reduction in urinary urgency incontinence episodes compared to baseline.
The company note that completion of two-year follow-ups concludes the ARTISAN-SNM study. The news release also acknowledges that due to COVID-19, upcoming medical meetings and conferences have been cancelled or restricted to virtual meetings. However, it states that detailed study results will be presented to interested parties by study investigators via an Axonics-hosted webinar to be announced in the coming weeks.