TY - JOUR
T1 - Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
AU - Pezzella, A.
AU - McCrery, R.
AU - Lane, F.
AU - Benson, K.
AU - Taylor, C.
AU - Padron, O.
AU - Blok, B.
AU - de Wachter, S.
AU - Gruenenfelder, J.
AU - Pakzad, M.
AU - Perrouin-Verbe, M.A.
AU - van Kerrebroeck, P.
AU - Mangel, J.
AU - Peters, K.
AU - Kennelly, M.
AU - Shapiro, A.
AU - Lee, U.
AU - Comiter, C.
AU - Mueller, M.
AU - Goldman, H.B.
PY - 2021/2/1
Y1 - 2021/2/1
N2 - Aims Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics (R) System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented.Methods One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented.Results At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved >= 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 +/- 0.3 at baseline to 1.0 +/- 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred.Conclusions At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.
AB - Aims Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics (R) System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented.Methods One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented.Results At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved >= 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 +/- 0.3 at baseline to 1.0 +/- 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred.Conclusions At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.
KW - clinical trial
KW - implantable neurostimulator
KW - overactive bladder
KW - sacral neuromodulation
KW - urinary urgency incontinence
U2 - 10.1002/nau.24615
DO - 10.1002/nau.24615
M3 - Article
C2 - 33508155
VL - 40
SP - 714
EP - 721
JO - Neurourology and Urodynamics
JF - Neurourology and Urodynamics
SN - 0733-2467
IS - 2
ER -