PD35-08 4 YEARS OF THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III
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Résumé
You have accessJournal of UrologyCME1 Apr 2023PD35-08 4 YEARS OF THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III Rachel Mann, Jessica Delong, Ramon Virasoro, and Sean Elliott Rachel MannRachel Mann More articles by this author , Jessica DelongJessica Delong More articles by this author , Ramon VirasoroRamon Virasoro More articles by this author , and Sean ElliottSean Elliott More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003333.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Optilume Drug Coated Balloon has been studied in three clinical investigations (ROBUST I, II and III). ROBUST I was the first in man trial conducted as a single arm, prospective multicenter study in Latin America (4 sites, 53 subjects) followed by ROBUST II assessing early feasibility (5 sites, 15 subjects), and ROBUST III, the randomized pivotal trial (79 Optilume). Optilume data combined from all three studies are presented here. METHODS: A total of 148 subjects were treated with Optilume in ROBUST I, II and III in Latin America, Canada, and the United States. Men with strictures ≤ 3cm and 1-4 prior endoscopic interventions were treated with Optilume. Follow-up was completed at 3 months, 6 months and annually thereafter. All studies were designed to follow subjects through 5 years with Robust I at 4-year follow-up, Robust II at 3-year follow-up and Robust III at 2-year follow-up, currently. Outcomes included International Prostate Symptom Score (IPSS), quality of life, freedom from reintervention, erectile function, flow rate, and post-void residual volume. Subjects receiving secondary treatment were considered failures. The safety endpoint assessed serious urinary events. RESULTS: At the time of this abstract submission, IPSS improved in all patients treated with Optilume from 22.5 at baseline to 7.8 at 4 years. Peak urinary flow rate (Qmax) had a sharp improvement and was sustained through follow-up in all trials (7.1 to 14). Freedom from repeat intervention is approximately 73% at 4 year follow-up (Figure 1). Results will be updated at the time of the presentation. CONCLUSIONS: Subjects with recurrent bulbar strictures treated with Optilume® paclitaxel-coated balloon exhibited significant improvement in symptomatic and functional outcomes through 4 years post treatment with demonstrably improved recurrence rates. There was no impact on erectile function and there were no serious adverse events. Source of Funding: Urotronic © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e977 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rachel Mann More articles by this author Jessica Delong More articles by this author Ramon Virasoro More articles by this author Sean Elliott 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 | 0,005 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,004 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 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 ».