(068) Collective Optilume BPH 2-Year Clinical Outcomes: Combined Experience From the Pivotal Pinnacle and Everest Prospective Clinical Studies
Notice bibliographique
Résumé
Abstract Introduction The Optilume BPH Catheter System (Urotronic, Inc./Laborie Medical Technologies, Plymouth, MN, USA) is an FDA-approved, minimally invasive, drug-coated dilation system designed for addressing BPH-related LUTS. The TransUrethral Radial Balloon Open (TURBO) prostate procedure has been studied in 2 clinical investigations (EVEREST and PINNACLE). EVEREST is a prospective, non- randomized multi-center study (n=80) followed by PINNACLE, a prospective, multicenter randomized study (n=100). Combined clinical data from these two studies through 2-year follow-up is presented here. Objective To evaluate the safety, efficacy, and durability of the Optilume BPH Catheter System (TURBO procedure) for the treatment of BPH-related lower urinary tract symptoms (LUTS), using combined 2-year follow-up data from the EVEREST and PINNACLE clinical trials. Methods A total of 179 men with symptomatic BPH were treated with Optilume BPH in the 2 studies in Latin America, Canada, and the United States. The combined study cohort includes men with a mean age of 65 years and prostate volume of 41cc. Follow-up was completed at 3, 6, 12 months and annually thereafter. All studies were designed to follow subjects through 5-years. However, while long term data continues to be collected, we herein present the 2-year data, as it constitutes a complete dataset for both studies at the time of this abstract. Results IPSS improved in subjects treated with Optilume BPH from 22.9 at baseline to 9.7 at 2- years (Figure). Peak urinary flow rate in subjects treated with Optilume BPH went from 9.8mL/s at baseline to 18.1 mL/s at 2-years. Post-void residual volume improved from 75cc at baseline to 56cc at 2-years. Sexual function was not impacted based on the IIEF Overall Satisfaction score from 6.3 at baseline to 6.8 at 2-years. There were no reported transfusions, retrograde ejaculation, stress incontinence or stricture formation in the series. Surgical BPH retreatment was observed in 1.7% (n=3) of the patient population. Conclusions Subjects with BPH treated with Optilume BPH TURBO prostate procedure exhibited significant and sustained improvement in symptomatic and functional outcomes with a good safety profile. There was no impact to erectile function. 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 | 0,021 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,002 | 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) | 0,001 | 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 ».