Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.
clinical trial
implantable neurostimulator
overactive bladder
sacral neuromodulation
urinary urgency incontinence
Journal
Neurourology and urodynamics
ISSN: 1520-6777
Titre abrégé: Neurourol Urodyn
Pays: United States
ID NLM: 8303326
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
23
10
2020
revised:
17
12
2020
accepted:
31
12
2020
pubmed:
29
1
2021
medline:
23
6
2021
entrez:
28
1
2021
Statut:
ppublish
Résumé
Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® 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. 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. 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. 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.
Identifiants
pubmed: 33508155
doi: 10.1002/nau.24615
pmc: PMC7986436
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
714-721Informations de copyright
© 2021 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.
Références
Neurourol Urodyn. 2017 Mar;36(3):727-733
pubmed: 27062384
Eur Urol. 2018 Jul;74(1):66-73
pubmed: 29482936
Neuromodulation. 2019 Jun;22(4):489-492
pubmed: 30133071
J Urol. 2019 Sep;202(3):558-563
pubmed: 31039103
J Urol. 2018 Jan;199(1):229-236
pubmed: 28709886
Neurourol Urodyn. 2018 Jun;37(5):1823-1848
pubmed: 29641846
Neurourol Urodyn. 2018 Feb;37(S2):S1-S8
pubmed: 29336078
J Urol. 2006 Aug;176(2):627-32; discussion 632
pubmed: 16813906
Neurourol Urodyn. 2021 Feb;40(2):714-721
pubmed: 33508155
Adv Ther. 2020 Feb;37(2):637-643
pubmed: 31875299
BJU Int. 2019 May;123(5A):E7-E13
pubmed: 30537223
J Urol. 2007 Nov;178(5):2029-34
pubmed: 17869298
Neurourol Urodyn. 2020 Jun;39(5):1482-1488
pubmed: 32339339
Neurourol Urodyn. 2016 Feb;35(2):246-51
pubmed: 25546568
J Urol. 2020 Jan;203(1):185-192
pubmed: 31347955
Rheumatology (Oxford). 2017 Apr 1;56(4):581-588
pubmed: 28013205
Neuromodulation. 2017 Dec;20(8):816-824
pubmed: 28975677
Urology. 2016 Aug;94:57-63
pubmed: 27131966
JAMA Intern Med. 2019 Jun 24;:
pubmed: 31233095
Neurourol Urodyn. 2019 Aug;38(6):1595-1601
pubmed: 31044466
Eur Urol. 2014 Jan;65(1):79-95
pubmed: 24007713
BJU Int. 2011 Oct;108(7):1132-8
pubmed: 21231991