PD35-08 4 YEARS OF THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III
Bibliographic record
Abstract
You have accessJournal of UrologyCME1 Apr 2023PD35-08 4 YEARS OF THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III Rachel Mann, Jessica Delong, Ramon Virasoro, and Sean Elliott Rachel MannRachel Mann More articles by this author , Jessica DelongJessica Delong More articles by this author , Ramon VirasoroRamon Virasoro More articles by this author , and Sean ElliottSean Elliott More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003333.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Optilume Drug Coated Balloon has been studied in three clinical investigations (ROBUST I, II and III). ROBUST I was the first in man trial conducted as a single arm, prospective multicenter study in Latin America (4 sites, 53 subjects) followed by ROBUST II assessing early feasibility (5 sites, 15 subjects), and ROBUST III, the randomized pivotal trial (79 Optilume). Optilume data combined from all three studies are presented here. METHODS: A total of 148 subjects were treated with Optilume in ROBUST I, II and III in Latin America, Canada, and the United States. Men with strictures ≤ 3cm and 1-4 prior endoscopic interventions were treated with Optilume. Follow-up was completed at 3 months, 6 months and annually thereafter. All studies were designed to follow subjects through 5 years with Robust I at 4-year follow-up, Robust II at 3-year follow-up and Robust III at 2-year follow-up, currently. Outcomes included International Prostate Symptom Score (IPSS), quality of life, freedom from reintervention, erectile function, flow rate, and post-void residual volume. Subjects receiving secondary treatment were considered failures. The safety endpoint assessed serious urinary events. RESULTS: At the time of this abstract submission, IPSS improved in all patients treated with Optilume from 22.5 at baseline to 7.8 at 4 years. Peak urinary flow rate (Qmax) had a sharp improvement and was sustained through follow-up in all trials (7.1 to 14). Freedom from repeat intervention is approximately 73% at 4 year follow-up (Figure 1). Results will be updated at the time of the presentation. CONCLUSIONS: Subjects with recurrent bulbar strictures treated with Optilume® paclitaxel-coated balloon exhibited significant improvement in symptomatic and functional outcomes through 4 years post treatment with demonstrably improved recurrence rates. There was no impact on erectile function and there were no serious adverse events. Source of Funding: Urotronic © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e977 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rachel Mann More articles by this author Jessica Delong More articles by this author Ramon Virasoro More articles by this author Sean Elliott 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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| 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".