Clinical Data

_{2021, Neurourology Urodynamics, Pezzella et al.}

Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system

The ARTISAN-SNM study is a 129-patient, single-arm, prospective, multicenter, pivotal clinical study approved under an FDA Investigational Device Exemption (IDE) to evaluate the safety and efficacy of Axonics Therapy for urinary dysfunction. The study was conducted in a total of 19 centers, 14 in the United States, and 5 in Western Europe with 2-year follow-up.

93% experienced improvement at 2 years

93% of implanted patients had greater than or equal to 50% reduction in UUI symptoms.

94% satisfied at 2 years

94% of patients were “satisfied” with Axonics SNM therapy.

Less than 2% of patients reported implant site pain at 2 years

Less than 2% of patients reported implant site pain.

Download the study overview

Read the ARTISAN-SNM study two year results

_{2020, Neurourology Urodynamics, Blok et al.}

Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system

The RELAX-OAB study was a 51-patient, post-market clinical follow-up study in Europe designed to test the safety and efficacy of Axonics Therapy for the treatment of overactive bladder. The study was conducted across 7 European centers. Patients in the RELAX-OAB study have completed long-term follow-up out to 2 years, showing sustained efficacy and safety of Axonics Sacral Neuromodulation Therapy.

90% continued response

90% of test responders continued to respond to therapy at 2 years.

3x clinically meaningful improvement

In our clinical study, patients on average had a 29-point improvement (P <.0001; n=28) in quality of life, nearly 3 times the threshold for clinically meaningful improvement.