LBA-05 TREATMENT OF URINARY URGENCY INCONTINENCE USING A NOVEL RECHARGEABLE SNM SYSTEM: 6-MONTH RESULTS OF THE ARTISAN-SNM STUDY
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You have accessJournal of UrologySunday Next Frontier (LBA)1 Apr 2019LBA-05 TREATMENT OF URINARY URGENCY INCONTINENCE USING A NOVEL RECHARGEABLE SNM SYSTEM: 6-MONTH RESULTS OF THE ARTISAN-SNM STUDY Howard Goldman*, Felicia Lane, Rebecca McCrery, Kevin Benson, Chris Taylor, Osvaldo Padron, Stefan De Wachter, Bertil Blok, and Andrea Pezzella Howard Goldman*Howard Goldman* More articles by this author , Felicia LaneFelicia Lane More articles by this author , Rebecca McCreryRebecca McCrery More articles by this author , Kevin BensonKevin Benson More articles by this author , Chris TaylorChris Taylor More articles by this author , Osvaldo PadronOsvaldo Padron More articles by this author , Stefan De WachterStefan De Wachter More articles by this author , Bertil BlokBertil Blok More articles by this author , and Andrea PezzellaAndrea Pezzella More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000557497.26013.caAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Sacral Neuromodulation (SNM) is a guideline-recommended treatment for urinary and bowel dysfunction in patients that have failed conservative therapy. Historically, SNM has been delivered using a non-rechargeable device with a lifespan of 3 - 5 years, requiring surgery to replace the implanted neurostimulator due to battery depletion. Replacement surgery increases patient risks and health-care costs, which could be reduced by use of a long lived, rechargeable system. The Axonics r-SNM System, approved in Europe, Canada and Australia, is a miniaturized, rechargeable system designed to deliver therapy for at least 15 years. The ARTISAN-SNM study is a prospective, multi-center pivotal study conducted under an investigational device exemption from the US FDA with the purpose of gaining US marketing approval of the novel Axonics r-SNM System. METHODS: 129 subjects with urinary urgency incontinence across 19 centers in the US and Western Europe were treated with the Axonics r-SNM System. All subjects were implanted with a tined lead and a neurostimulator in a non-staged procedure. Efficacy data was collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a subject satisfaction questionnaire. Therapy responders at follow-up were identified as patients with a 50% reduction in urgency leaks compared to baseline. An as-treated analysis was performed in all implanted subjects. RESULTS: At 6 months, 90% of all implanted subjects were therapy responders (Fig A), of which 80% subjects had a greater than 75% reduction in urge leaks (34% were dry). Across all subjects, urge leaks per day reduced from 5.6 (0.3, standard error) at baseline to 1.3 (0.2) at 6 months (p<0.0001; Fig B). Subjects averaged 34 points improvement on the composite ICIQ-OABqol score as compared to baseline, which is statistically and clinically significant. Additionally, 95% of subjects were satisfied with their r-SNM therapy. One subject was explanted due to infection and one lead revision occurred due to migration. No serious device-related adverse events have been reported. CONCLUSIONS: At 6 months, patients implanted with the Axonics r-SNM System received clinically and statistically significant improvements in UUI symptoms and quality of life. Source of Funding: Axonics Note: The terms Axonics and r-SNM are trade-marked Cleveland, OH; Orange, CA; Omaha, NE; Sioux Falls, SD; Harrison, AR; Tampa, FL; Edegem, Belgium; Rotterdam, Netherlands; West Columbia, SC© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e993-e994 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Howard Goldman* More articles by this author Felicia Lane More articles by this author Rebecca McCrery More articles by this author Kevin Benson More articles by this author Chris Taylor More articles by this author Osvaldo Padron More articles by this author Stefan De Wachter More articles by this author Bertil Blok More articles by this author Andrea Pezzella More articles by this author Expand All Advertisement PDF downloadLoading ...
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,003 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».