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

AIMS: 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...

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Autores principales: Pezzella, Andrea, McCrery, Rebecca, Lane, Felicia, Benson, Kevin, Taylor, Chris, Padron, Osvaldo, Blok, Bertil, de Wachter, Stefan, Gruenenfelder, Jennifer, Pakzad, Mahreen, Perrouin‐Verbe, Marie‐Aimee, van Kerrebroeck, Philip, Mangel, Jeffrey, Peters, Kenneth, Kennelly, Michael, Shapiro, Andrew, Lee, Una, Comiter, Craig, Mueller, Margaret, Goldman, Howard B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986436/
https://www.ncbi.nlm.nih.gov/pubmed/33508155
http://dx.doi.org/10.1002/nau.24615
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author Pezzella, Andrea
McCrery, Rebecca
Lane, Felicia
Benson, Kevin
Taylor, Chris
Padron, Osvaldo
Blok, Bertil
de Wachter, Stefan
Gruenenfelder, Jennifer
Pakzad, Mahreen
Perrouin‐Verbe, Marie‐Aimee
van Kerrebroeck, Philip
Mangel, Jeffrey
Peters, Kenneth
Kennelly, Michael
Shapiro, Andrew
Lee, Una
Comiter, Craig
Mueller, Margaret
Goldman, Howard B.
author_facet Pezzella, Andrea
McCrery, Rebecca
Lane, Felicia
Benson, Kevin
Taylor, Chris
Padron, Osvaldo
Blok, Bertil
de Wachter, Stefan
Gruenenfelder, Jennifer
Pakzad, Mahreen
Perrouin‐Verbe, Marie‐Aimee
van Kerrebroeck, Philip
Mangel, Jeffrey
Peters, Kenneth
Kennelly, Michael
Shapiro, Andrew
Lee, Una
Comiter, Craig
Mueller, Margaret
Goldman, Howard B.
author_sort Pezzella, Andrea
collection PubMed
description AIMS: 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. 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.
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spelling pubmed-79864362021-03-25 Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system Pezzella, Andrea McCrery, Rebecca Lane, Felicia Benson, Kevin Taylor, Chris Padron, Osvaldo Blok, Bertil de Wachter, Stefan Gruenenfelder, Jennifer Pakzad, Mahreen Perrouin‐Verbe, Marie‐Aimee van Kerrebroeck, Philip Mangel, Jeffrey Peters, Kenneth Kennelly, Michael Shapiro, Andrew Lee, Una Comiter, Craig Mueller, Margaret Goldman, Howard B. Neurourol Urodyn Original Clinical Articles AIMS: 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. 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. John Wiley and Sons Inc. 2021-01-28 2021-02 /pmc/articles/PMC7986436/ /pubmed/33508155 http://dx.doi.org/10.1002/nau.24615 Text en © 2021 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Clinical Articles
Pezzella, Andrea
McCrery, Rebecca
Lane, Felicia
Benson, Kevin
Taylor, Chris
Padron, Osvaldo
Blok, Bertil
de Wachter, Stefan
Gruenenfelder, Jennifer
Pakzad, Mahreen
Perrouin‐Verbe, Marie‐Aimee
van Kerrebroeck, Philip
Mangel, Jeffrey
Peters, Kenneth
Kennelly, Michael
Shapiro, Andrew
Lee, Una
Comiter, Craig
Mueller, Margaret
Goldman, Howard B.
Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
title Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
title_full Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
title_fullStr Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
title_full_unstemmed Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
title_short Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
title_sort two‐year outcomes of the artisan‐snm study for the treatment of urinary urgency incontinence using the axonics rechargeable sacral neuromodulation system
topic Original Clinical Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986436/
https://www.ncbi.nlm.nih.gov/pubmed/33508155
http://dx.doi.org/10.1002/nau.24615
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