Irvine, CA and Florence, Italy – Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, today announced the presentation of positive results from its prospective, multicenter clinical study at the 2017 International Continence Society (ICS) Congress in Florence, Italy.
The presentation, entitled “A prospective multicenter clinical study evaluating a miniaturized rechargeable sacral neuromodulation system for the safe and effective treatment of overactive bladder (RELAX-OAB study),” was delivered by Bertil F.M. Blok M.D., PhD, Dept. of Urology, Erasmus University Medical Centre, Rotterdam, Netherlands.
A total of 51 overactive bladder patients with symptoms of urinary urgency incontinence (UUI) and urgency-frequency (UF) were implanted in the RELAX-OAB study at seven centers in the Netherlands, France, Belgium and the UK. All subjects have reached their primary endpoint.
The results presented included outcomes at three and six months post-implant and provided significant evidence that the Axonics r-SNM system is safe and efficacious. Over one quarter of the subjects had previously failed Botox or posterior tibial nerve stimulation. The median age of the cohort was 52 years and consisted of 75% females. At baseline, subjects averaged 14.3 voids per day and 9.6 urinary incontinence episodes (leaks) per day. All subjects were implanted with an Axonics miniaturized rechargeable neurostimulator and did not undergo an external test stimulation typically used to screen patients. At one month, 71% of all implanted subjects were initial responders to therapy defined as a 50% or greater reduction in incontinence or UF symptoms, or for UF subjects, a return to normal equal to eight or less voids per day.
Data at six months post-implant demonstrated:
- 94% of initial responders continued to respond to therapy
- 85% of UUI subjects experienced a 50% or greater reduction in leaks per day
- 81% of UF subjects experienced a 50% or greater reduction in voids per day or a reduction to less than eight voids per day
- Initial responders reported clinically meaningful improvements in quality of life, underscored by significant improvements from baseline in the ICIQ-OABqol HRQL score of 26.2 points (+/- 4.1, SE, n=33)
- All subjects but one could successfully charge their neurostimulator within the first month following implant
- There were no serious adverse device effects or unanticipated adverse device effects reported
“All the RELAX-OAB subjects have reached the 6-month post-implant time point and as expected, the Axonics r-SNM system is delivering safe and clinically significant symptom relief to patients,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “The next major step for Axonics is to get our US pivotal study underway. To that end, we have over 12 centers in North America and Western Europe poised to treat patients immediately following FDA clearance of our pending IDE.”
During 2016, the Axonics r-SNM system gained regulatory approval in Europe and Canada for the treatment of overactive bladder, urinary retention, and fecal incontinence.