MP27-01 24-MONTH OUTCOMES FROM THE ZEST PILOT STUDIES OF THE ZENFLOW SPRING SYSTEM FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
Bibliographic record
Abstract
You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (MP27)1 May 2024MP27-01 24-MONTH OUTCOMES FROM THE ZEST PILOT STUDIES OF THE ZENFLOW SPRING SYSTEM FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Peter Gilling, Peter Chin, Paul Anderson, Kevin C. Zorn, Edward Matsumoto, William Lynch, Lewis Chan, Henry Woo, Juan José Galán Maraboto, Lauro Salvador Gómez Guerra, Rodrigo Pérez Becerra, Janelle Brennan, and Dean Elterman Peter GillingPeter Gilling , Peter ChinPeter Chin , Paul AndersonPaul Anderson , Kevin C. ZornKevin C. Zorn , Edward MatsumotoEdward Matsumoto , William LynchWilliam Lynch , Lewis ChanLewis Chan , Henry WooHenry Woo , Juan José Galán MarabotoJuan José Galán Maraboto , Lauro Salvador Gómez GuerraLauro Salvador Gómez Guerra , Rodrigo Pérez BecerraRodrigo Pérez Becerra , Janelle BrennanJanelle Brennan , and Dean EltermanDean Elterman View All Author Informationhttps://doi.org/10.1097/01.JU.0001009400.86696.a2.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Zenflow Spring System is a novel minimally invasive surgical therapy (MIST) that delivers an appropriately sized nitinol urethral expander device into the prostatic urethra displacing the lateral lobes for improved urinary flow. The ZEST pilot studies are prospective single-arm clinical studies evaluating the Zenflow Spring System for BPH. Three clinical trials were conducted using the same eligibility criteria across 4 countries (Mexico, Australia, New Zealand, Canada). METHODS: Seventy-two (72) subjects received the device. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS) and IPSS-QOL, and functional improvement was measured by peak urinary flow rate (Qmax). Overall effectiveness measures were calculated using a mixed model repeated measures (MMRM) analysis, which incorporates within-patient correlations and missing data, and equally weighs results from each study. RESULTS: Subjects treated with the Zenflow Spring showed a significant reduction in IPSS from baseline to 24 months (22.0 to 11.4), representing a 48% improvement in IPSS. IPSS QOL significantly reduced from baseline to 24 months (4.5 vs 1.85) representing a 59% improvement. Qmax increased from 10.5 mL/sec at baseline to 14.0 mL/sec at 24 months representing a 33% improvement. The responder rate at 12 and 24 months, calculated as those with at least 30% improvement in IPSS, was 75% (48/64 subjects) and 70% (39/56), respectively. CONCLUSIONS: The Zenflow Spring System resulted in immediate, significant, and durable symptomatic improvements from 1 through 24 months. Subjects experienced improvements in symptoms, quality of life, maximum flow rate without any sexual dysfunction through 24 months of follow up. These results are currently being validated through a large, multi-center, prospective randomized study in the United States and Canada. Source of Funding: Zenflow © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e423 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Peter Gilling More articles by this author Peter Chin More articles by this author Paul Anderson More articles by this author Kevin C. Zorn More articles by this author Edward Matsumoto More articles by this author William Lynch More articles by this author Lewis Chan More articles by this author Henry Woo More articles by this author Juan José Galán Maraboto More articles by this author Lauro Salvador Gómez Guerra More articles by this author Rodrigo Pérez Becerra More articles by this author Janelle Brennan More articles by this author Dean Elterman 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 | 0.003 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.037 | 0.005 |
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".