PD10-12 WATER II: AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA IN MEN WITH LARGE PROSTATES (80-150CC): 6-MONTH SAFETY AND EFFICACY RESULTS
Notice bibliographique
Résumé
You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (PD10)1 Apr 2019PD10-12 WATER II: AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA IN MEN WITH LARGE PROSTATES (80-150CC): 6-MONTH SAFETY AND EFFICACY RESULTS Naeem Bhojani* Naeem Bhojani*Naeem Bhojani* More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555282.09572.5cAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: In a large, blinded, multicenter, randomized trial (WATER) (30-80cc), Aquablation, an ultrasound-guided, robotically executed waterjet ablative procedure demonstrated better outcomes in larger glands compared to TURP. These observations identified the need to assess the safety and efficacy of performing Aquablation in men with larger prostate glands (80-150cc) (WATER II). Herein we report the 6-month outcomes. METHODS: Between September and December 2017, 101 men with moderate-to-severe benign prostatic hyperplasia symptoms and prostate volume of 80-150cc underwent Aquablation in a prospective multicenter international clinical trial. Baseline demographics and standardized postoperative management parameters were carefully recorded in a central independently monitored database. Functional and safety outcomes were assessed at 6 months postoperatively. RESULTS: Mean prostate volume was 107cc (range 80-150). Mean operative time was 37 minutes with a mean Aquablation resection time of 8 minutes (range 3-17 minutes) and a mean of 1.8 treatment passes. The average length of stay following the procedure was 1.6 days (range same day-6 days). Bleeding complications were recorded in 10 (9.9%) patients during the index procedure hospitalization prior to discharge and included six (5.9%) peri-operative transfusions. The primary safety endpoint (Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of less than 65% (p<0.0001). Mean IPSS improved from 23.2 (+/-6.3) at baseline to 11.5 (+/-6.6) at 1 month and 6.7 (+/-5.1) at 3 months meeting the study's primary efficacy endpoint goal (p<0.0001). IPSS at 6 months was 5.9 (+/-5.4), a 75% reduction. Maximum urinary flow rate increased from 8.7 to 18.8 cc/sec (an improvement of 10.4 cc/sec, p<0.0001) and post-void residual decreased from 131 at baseline to 47 at 6 months (a 91-cc decrease). 81% of the sexually active men in this study (107cc baseline prostate size) maintained their ejaculatory function. At 6 months, PSA reduced from 7.1 (+/-5.9) ng/mL to 4.0 (3.9+/-) ng/mL, a 44% reduction. CONCLUSIONS: With 6 months follow-up, Aquablation is safe and effective in treating men with larger prostates (80-150cc) without significant increase in procedure or resection time. The one year follow up will be completed in December 2018 and those results will be available for the 2019 AUA Congress. ClinicalTrials.gov number, NCT03123250. Presentation on behalf of the Water II investigators Source of Funding: PROCEPT BioRobotics Montreal, Canada© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e163-e163 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Naeem Bhojani* 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 | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| 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 ».