Scottsdale, Arizona (UroToday.com) Dr. Kevin Benson presented the clinical outcome, safety and the effectivance of Axonics® System at 1 year follow up in the ARTISAN-SNM study. The Axonix system is a miniaturized sacral neuromodulation (SNM) System qualified to function for at least 15 years in the body and approval for patients to undergo conditional full-body MRI scans. The Axonics System is expected to reduce or eliminate the patient risks and costs which result from the frequent replacement surgeries associated with a non-rechargeable SNM system.
There was a 129 participants with urinary urgency incontinence (UUI) across 19 centers in the US and Europe were implanted with the Axonics System in a single,non-staged procedure. Efficacy data was collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were identified as participants with ≥50% reduction in urgency leaks compared to baseline. An as-treated analysis was performed in all implanted participants.
At 1 year, 89% of all implanted participants were therapy responders (p<0.0001,Fig 1A). UUI episodes per day reduced from 5.6 ± 0.3 (average ± standard error) at baseline to 1.4 ± 0.2 (p<0.0001;Fig 1B). Of the responders, 77% had ≥75% reduction in UUI episodes and 29% were dry.
As compared to baseline, ICIQ-OABqol scores improved by 34 points, which is clinically and statistically significant (p<0.0001). Ninety six percent (96%) of participants responded that the recharging duration and frequency was acceptable, and 93% were satisfied with their SNM therapy.
No serious device-related adverse events have been reported. Revisions and device-related explants occurred in approximately 3% patients.
The authors reported that Axonics System showed sustained safety and efficacy at 1 year for treatment of UUI. Patients reported that recharging frequency and duration of their SNM system was acceptable.
Co-authors: Rebecca McCrery, MD2,Chris Taylor,MD3,Osvaldo Padron,MD4,Bertil Blok,MD5,Stefan De Wachter,MD6,Andrea Pezzella,MD7,Howard B. Goldman,MD8,Felicia Lane,MD9
1. Sanford Hospital,Sioux Falls, South Dakota
2. Adult & Pediatric Urology & Urogynecology,Omaha,Nebraska
3. Taylor Surgical Arts,Harrison, Arkansas
4. Florida Urology Partners,Tampa, Florida
5. Department of Urology, Erasmus MC,Rotterdam, The Netherlands
6. Department of Urology,University Hospital Antwerpen,Edegem, Belgium
7. Southern Urogynecology, West Columbia, South Carolina
8. Cleveland Clinic,Cleveland, Ohio
9. University of California,Irvine, California