PD10-12 WATER II: AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA IN MEN WITH LARGE PROSTATES (80-150CC): 6-MONTH SAFETY AND EFFICACY RESULTS
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Abstract
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 ...
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".