(069) Optilume BPH Transurethral Radial Balloon Opening Prostate Procedure: Reproducible and Consistent Outcomes Across Varied Clinical Settings and Physician Expertise Levels
Bibliographic record
Abstract
Abstract Introduction The Optilume BPH Catheter System has emerged as a promising minimally invasive surgical therapy for treating LUTS secondary to BPH. This analysis provides valuable insight into the reproducibility of the Optilume BPH procedure's effectiveness and its potential for widespread adoption across diverse clinical environments and physician expertise levels, pooling data from two prospective multicenter studies: EVEREST and PINNACLE at 2-year follow-up. Objective To evaluate the reproducibility, durability, and safety of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH, by pooling 2-year follow-up data from the prospective, multicenter EVEREST and PINNACLE clinical studies across diverse clinical settings and operator experience levels. Methods A total of 179 subjects with symptomatic BPH were treated with Optilume BPH Catheter System in two multicenter studies (EVEREST and PINNACLE) in Latin America, Canada, and the United States. The treatment of these subjects involved 28 different treating physicians in a variety of settings including ambulatory surgery centers, hospitals and in-office. Surgeons were stratified into two cohorts based on experience: those who performed >10 procedures and those who performed ≤10. Functional outcomes were assessed preoperatively as well as at 3 months, 6 months, and annually thereafter. All studies were designed to follow subjects through 5-years. Results At baseline, subjects had a mean age of 65 years and mean prostate volume of 41cc (range 20.6-77cc). Each physician performed an average of 6.4 Optilume BPH procedures, with 3 urologists completing more than ten procedures (11%). Across all treated subjects, regardless of age, fellowship training, annual BPH surgical volume, there was a consistent and significant improvement in functional outcomes. High and low volume surgeon groups had comparable age, prostate volume, IPSS and functional urinary parameters. At two years, the IPSS demonstrated a mean improvement of 57.5% for high-volume surgeons, and 59.5% for low-volume surgeons. The analysis, summarized in Figure 1, further revealed no significant differences in PVR, QOL as well as durability at 2 years (all p>0.05). Clavien-Dindo 30-day complications rates were similar across both groups. Conclusions The Optilume BPH Prostate Catheter System demonstrates significant, consistent and durable improvements in functional outcomes for BPH patients, with reproducible results across varying levels of physician experience and clinical settings. Disclosure Yes, this is sponsored by industry/sponsor: Urotronic, Inc. (a subsidiary of Laborie Medical Technologies Corp.) is the sponsor for the studies included Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Procept Biorobotics, Boston Scientific, Laborie Medical Technologies, Olympus, Zenflow, Medtronic, Astellas, Sumitomo Pharma America, Emano Flow, Promaxo, Ibex Medical Analytics, BioProtect Ltd, Oxford BioDynamics, Soundable Health, Clinical Laserthermia Systems Americas, Marius Pharmaceuticals, Sonablate Corp, PathNet, DeepSpin GmbH, GoPath Diagnostics, Cortechs.AI, Proverum
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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 | 0.006 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".