PD41-03 12-MONTH OUTCOMES FROM A RANDOMIZED, SHAM CONTROLLED STUDY EVALUATING A NOVEL DRUG COATED BALLOON FOR THE TREATMENT OF BPH
Bibliographic record
Abstract
You have accessJournal of UrologyCME1 Apr 2023PD41-03 12-MONTH OUTCOMES FROM A RANDOMIZED, SHAM CONTROLLED STUDY EVALUATING A NOVEL DRUG COATED BALLOON FOR THE TREATMENT OF BPH Steven A. Kaplan, Jared Moss, Sheldon Freedman, Karl Coutinho, Ning Wu, Mitchell Efros, Dean Elterman, Richard D'Anna, Osvaldo Padron, Kaiser J. Robertson, Samuel Lawindy, Sandeep Mistry, Neal Shore, Jeffrey Spier, Jed Kaminestky, Brian Mazzarella, David Cahn, Mark Jalkut, and Alexis Te Steven A. KaplanSteven A. Kaplan More articles by this author , Jared MossJared Moss More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Karl CoutinhoKarl Coutinho More articles by this author , Ning WuNing Wu More articles by this author , Mitchell EfrosMitchell Efros More articles by this author , Dean EltermanDean Elterman More articles by this author , Richard D'AnnaRichard D'Anna More articles by this author , Osvaldo PadronOsvaldo Padron More articles by this author , Kaiser J. RobertsonKaiser J. Robertson More articles by this author , Samuel LawindySamuel Lawindy More articles by this author , Sandeep MistrySandeep Mistry More articles by this author , Neal ShoreNeal Shore More articles by this author , Jeffrey SpierJeffrey Spier More articles by this author , Jed KaminestkyJed Kaminestky More articles by this author , Brian MazzarellaBrian Mazzarella More articles by this author , David CahnDavid Cahn More articles by this author , Mark JalkutMark Jalkut More articles by this author , and Alexis TeAlexis Te More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The PINNACLE study is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System. Optilume BPH is a novel minimally invasive surgical therapy (MIST) that combines mechanical dilation with the delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing. METHODS: 148 subjects were randomized in a 2:1 fashion at 18 centers in the US and Canada. Subjects and evaluating personnel were blinded to treatment through 12-months. 12-month follow-up is complete. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS) and BPH Impact Index (BPH-II), functional improvement measured by peak urinary flow rate (Qmax) and post-void residual volume (PVR). Erectile and ejaculatory function were evaluated utilizing validated questionnaires. Adverse events were prospectively collected and relatedness to treatment was adjudicated by an independent, blinded clinical events committee. RESULTS: Subjects treated with Optilume BPH showed a significant reduction in IPSS through 12 months (23.4 vs 10.9, p<0.001). Improvement in IPSS at 12 months was significantly greater for Optilume BPH compared to Sham in the intent-to-treat population (11.5 vs 4.8, p<0.001). Qmax more than doubled from 8.9 mL/sec at baseline to 19.0 mL/sec after treatment with Optilume BPH, while average PVR decreased from 84 mL to 58 mL (p=0.004). There were no changes in perceived sexual or ejaculatory function. The most reported treatment related adverse events after treatment with Optilume BPH included hematuria (39/98 [39.8%]), urinary tract infection (11/98 [11.2%]), and dysuria (8/98 [8.2%]). CONCLUSIONS: Treatment with Optilume BPH resulted in significant, immediate symptomatic and functional improvements and to date the highest Qmax reported in BPH MIST trials. Durability of these outcomes was shown through 12 months follow-up, demonstrating the intended effect of an immediate mechanical benefit that is sustained long-term by the delivery of paclitaxel. Long-term outcomes will be verified with 5 year follow-up for Optilume BPH. Source of Funding: Urotronic, Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1059 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven A. Kaplan More articles by this author Jared Moss More articles by this author Sheldon Freedman More articles by this author Karl Coutinho More articles by this author Ning Wu More articles by this author Mitchell Efros More articles by this author Dean Elterman More articles by this author Richard D'Anna More articles by this author Osvaldo Padron More articles by this author Kaiser J. Robertson More articles by this author Samuel Lawindy More articles by this author Sandeep Mistry More articles by this author Neal Shore More articles by this author Jeffrey Spier More articles by this author Jed Kaminestky More articles by this author Brian Mazzarella More articles by this author David Cahn More articles by this author Mark Jalkut More articles by this author Alexis Te 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 | 0.004 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.013 | 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".