MP27-02 24-MONTH SEXUAL HEALTH 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 2024MP27-02 24-MONTH SEXUAL HEALTH 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.a2.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The ZEST pilot studies are three prospective single-arm feasibility studies conducted to demonstrate safety and provide evidence of effectiveness of the Zenflow Spring System for BPH. 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. METHODS: Seventy-two (72) subjects received the device as part of ZEST pilot studies. Safety endpoints included monitoring changes from baseline in sexual health with validated questionnaires throughout follow-up (3, 6, 12, 24 months post-implant and every year thereafter). Erectile function was characterized by the Sexual Health Inventory for Men (SHIM) and ejaculatory function by Male Sexual Health Questionnaire – Ejaculatory Domain (MSHQ-EjD). SHIM inventories indicating lack of sexual activity were excluded from analysis. RESULTS: No deterioration in erectile or ejaculatory function was seen over time through 24 months post-implant. This lack of deterioration is demonstrated by improvements in group mean scores for both inventories post-implant (Table 1). The proportion of subjects bothered by ejaculatory function declined following implant, as did the proportion of subjects with symptoms of erectile dysfunction. CONCLUSIONS: Experience through 24 months following placement of the Zenflow Spring System in 72 subjects demonstrated no negative impact on sexual health. The safety and effectiveness of the Zenflow Spring System is currently being evaluated as part of a large, multi-center, prospective randomized study in the United States and Canada. Reference Kasman AM, Bhambhvani HP, Eisenberg ML. Ejaculatory Dysfunction in Patients Presenting to a Men's Health Clinic: A Retrospective Cohort Study. J Sex Med 2020; 8: 454-460. 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 | 0.008 |
| 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 | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.047 | 0.006 |
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".