MP27-01 24-MONTH OUTCOMES FROM THE ZEST PILOT STUDIES OF THE ZENFLOW SPRING SYSTEM FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
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Résumé
You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (MP27)1 May 2024MP27-01 24-MONTH OUTCOMES FROM THE ZEST PILOT STUDIES OF THE ZENFLOW SPRING SYSTEM FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Peter Gilling, Peter Chin, Paul Anderson, Kevin C. Zorn, Edward Matsumoto, William Lynch, Lewis Chan, Henry Woo, Juan José Galán Maraboto, Lauro Salvador Gómez Guerra, Rodrigo Pérez Becerra, Janelle Brennan, and Dean Elterman Peter GillingPeter Gilling , Peter ChinPeter Chin , Paul AndersonPaul Anderson , Kevin C. ZornKevin C. Zorn , Edward MatsumotoEdward Matsumoto , William LynchWilliam Lynch , Lewis ChanLewis Chan , Henry WooHenry Woo , Juan José Galán MarabotoJuan José Galán Maraboto , Lauro Salvador Gómez GuerraLauro Salvador Gómez Guerra , Rodrigo Pérez BecerraRodrigo Pérez Becerra , Janelle BrennanJanelle Brennan , and Dean EltermanDean Elterman View All Author Informationhttps://doi.org/10.1097/01.JU.0001009400.86696.a2.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Zenflow Spring System is a novel minimally invasive surgical therapy (MIST) that delivers an appropriately sized nitinol urethral expander device into the prostatic urethra displacing the lateral lobes for improved urinary flow. The ZEST pilot studies are prospective single-arm clinical studies evaluating the Zenflow Spring System for BPH. Three clinical trials were conducted using the same eligibility criteria across 4 countries (Mexico, Australia, New Zealand, Canada). METHODS: Seventy-two (72) subjects received the device. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS) and IPSS-QOL, and functional improvement was measured by peak urinary flow rate (Qmax). Overall effectiveness measures were calculated using a mixed model repeated measures (MMRM) analysis, which incorporates within-patient correlations and missing data, and equally weighs results from each study. RESULTS: Subjects treated with the Zenflow Spring showed a significant reduction in IPSS from baseline to 24 months (22.0 to 11.4), representing a 48% improvement in IPSS. IPSS QOL significantly reduced from baseline to 24 months (4.5 vs 1.85) representing a 59% improvement. Qmax increased from 10.5 mL/sec at baseline to 14.0 mL/sec at 24 months representing a 33% improvement. The responder rate at 12 and 24 months, calculated as those with at least 30% improvement in IPSS, was 75% (48/64 subjects) and 70% (39/56), respectively. CONCLUSIONS: The Zenflow Spring System resulted in immediate, significant, and durable symptomatic improvements from 1 through 24 months. Subjects experienced improvements in symptoms, quality of life, maximum flow rate without any sexual dysfunction through 24 months of follow up. These results are currently being validated through a large, multi-center, prospective randomized study in the United States and Canada. Source of Funding: Zenflow © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e423 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Peter Gilling More articles by this author Peter Chin More articles by this author Paul Anderson More articles by this author Kevin C. Zorn More articles by this author Edward Matsumoto More articles by this author William Lynch More articles by this author Lewis Chan More articles by this author Henry Woo More articles by this author Juan José Galán Maraboto More articles by this author Lauro Salvador Gómez Guerra More articles by this author Rodrigo Pérez Becerra More articles by this author Janelle Brennan More articles by this author Dean Elterman 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 | 0,003 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,037 | 0,005 |
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 ».