(215) THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: ROBUST III STUDY 4-YEAR INTERIM RESULTS
Bibliographic record
Abstract
Abstract Introduction The ROBUST III study is a randomized controlled trial comparing the Optilume® Drug Coated Balloon (DCB) against direct visual internal urethrotomy (DVIU) or dilation. The Optilume® Drug Coated Balloon (DCB) is a dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. Outcomes after 4-year follow-up are presented here. Objective To determine long-term endpoints after Optilume® DCB including freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax). Methods 127 subjects were randomized in a 2:1 fashion at 23 sites. Seventy-nine were treated with the DCB and 48 were treated with DVIU or dilation. Follow-up past 1 year was limited to those treated with the DCB. Eligibility criteria included adult males with anterior strictures with ≥2 prior treatments and stricture length ≤ 3 cm. Results Subjects randomized to receive the DCB had an average of 3.2 prior treatments and average stricture length of 1.6 cm (46% ≥ 2 cm), with 8/79 (10.1%) having penile strictures and 9/79 (11.4%) having prior pelvic radiation. IPSS significantly improved from 21.9 at baseline to 12.6 at 4 years. Qmax significantly improved from a baseline of 7.7 mL/sec to 13.2 mL/sec at 4 years. Freedom from repeat intervention for DCB subjects was estimated to be 71%. No late-onset treatment related adverse events were observed. Conclusions The Optilume® DCB continues to achieve significant improvements in symptoms, flow, and reintervention rates through 4 years post treatment. Disclosure Yes, this is sponsored by industry/sponsor: Laborie. Clarification: Industry funding only - investigator initiated and executed study.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".