(069) Optilume BPH Transurethral Radial Balloon Opening Prostate Procedure: Reproducible and Consistent Outcomes Across Varied Clinical Settings and Physician Expertise Levels
Notice bibliographique
Résumé
Abstract Introduction The Optilume BPH Catheter System has emerged as a promising minimally invasive surgical therapy for treating LUTS secondary to BPH. This analysis provides valuable insight into the reproducibility of the Optilume BPH procedure's effectiveness and its potential for widespread adoption across diverse clinical environments and physician expertise levels, pooling data from two prospective multicenter studies: EVEREST and PINNACLE at 2-year follow-up. Objective To evaluate the reproducibility, durability, and safety of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH, by pooling 2-year follow-up data from the prospective, multicenter EVEREST and PINNACLE clinical studies across diverse clinical settings and operator experience levels. Methods A total of 179 subjects with symptomatic BPH were treated with Optilume BPH Catheter System in two multicenter studies (EVEREST and PINNACLE) in Latin America, Canada, and the United States. The treatment of these subjects involved 28 different treating physicians in a variety of settings including ambulatory surgery centers, hospitals and in-office. Surgeons were stratified into two cohorts based on experience: those who performed >10 procedures and those who performed ≤10. Functional outcomes were assessed preoperatively as well as at 3 months, 6 months, and annually thereafter. All studies were designed to follow subjects through 5-years. Results At baseline, subjects had a mean age of 65 years and mean prostate volume of 41cc (range 20.6-77cc). Each physician performed an average of 6.4 Optilume BPH procedures, with 3 urologists completing more than ten procedures (11%). Across all treated subjects, regardless of age, fellowship training, annual BPH surgical volume, there was a consistent and significant improvement in functional outcomes. High and low volume surgeon groups had comparable age, prostate volume, IPSS and functional urinary parameters. At two years, the IPSS demonstrated a mean improvement of 57.5% for high-volume surgeons, and 59.5% for low-volume surgeons. The analysis, summarized in Figure 1, further revealed no significant differences in PVR, QOL as well as durability at 2 years (all p>0.05). Clavien-Dindo 30-day complications rates were similar across both groups. Conclusions The Optilume BPH Prostate Catheter System demonstrates significant, consistent and durable improvements in functional outcomes for BPH patients, with reproducible results across varying levels of physician experience and clinical settings. Disclosure Yes, this is sponsored by industry/sponsor: Urotronic, Inc. (a subsidiary of Laborie Medical Technologies Corp.) is the sponsor for the studies included Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Procept Biorobotics, Boston Scientific, Laborie Medical Technologies, Olympus, Zenflow, Medtronic, Astellas, Sumitomo Pharma America, Emano Flow, Promaxo, Ibex Medical Analytics, BioProtect Ltd, Oxford BioDynamics, Soundable Health, Clinical Laserthermia Systems Americas, Marius Pharmaceuticals, Sonablate Corp, PathNet, DeepSpin GmbH, GoPath Diagnostics, Cortechs.AI, Proverum
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 | 0,006 | 0,008 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
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 ».