LBA-05 TREATMENT OF URINARY URGENCY INCONTINENCE USING A NOVEL RECHARGEABLE SNM SYSTEM: 6-MONTH RESULTS OF THE ARTISAN-SNM STUDY
Bibliographic record
Abstract
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 ...
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".