(068) Collective Optilume BPH 2-Year Clinical Outcomes: Combined Experience From the Pivotal Pinnacle and Everest Prospective Clinical Studies
Bibliographic record
Abstract
Abstract Introduction The Optilume BPH Catheter System (Urotronic, Inc./Laborie Medical Technologies, Plymouth, MN, USA) is an FDA-approved, minimally invasive, drug-coated dilation system designed for addressing BPH-related LUTS. The TransUrethral Radial Balloon Open (TURBO) prostate procedure has been studied in 2 clinical investigations (EVEREST and PINNACLE). EVEREST is a prospective, non- randomized multi-center study (n=80) followed by PINNACLE, a prospective, multicenter randomized study (n=100). Combined clinical data from these two studies through 2-year follow-up is presented here. Objective To evaluate the safety, efficacy, and durability of the Optilume BPH Catheter System (TURBO procedure) for the treatment of BPH-related lower urinary tract symptoms (LUTS), using combined 2-year follow-up data from the EVEREST and PINNACLE clinical trials. Methods A total of 179 men with symptomatic BPH were treated with Optilume BPH in the 2 studies in Latin America, Canada, and the United States. The combined study cohort includes men with a mean age of 65 years and prostate volume of 41cc. Follow-up was completed at 3, 6, 12 months and annually thereafter. All studies were designed to follow subjects through 5-years. However, while long term data continues to be collected, we herein present the 2-year data, as it constitutes a complete dataset for both studies at the time of this abstract. Results IPSS improved in subjects treated with Optilume BPH from 22.9 at baseline to 9.7 at 2- years (Figure). Peak urinary flow rate in subjects treated with Optilume BPH went from 9.8mL/s at baseline to 18.1 mL/s at 2-years. Post-void residual volume improved from 75cc at baseline to 56cc at 2-years. Sexual function was not impacted based on the IIEF Overall Satisfaction score from 6.3 at baseline to 6.8 at 2-years. There were no reported transfusions, retrograde ejaculation, stress incontinence or stricture formation in the series. Surgical BPH retreatment was observed in 1.7% (n=3) of the patient population. Conclusions Subjects with BPH treated with Optilume BPH TURBO prostate procedure exhibited significant and sustained improvement in symptomatic and functional outcomes with a good safety profile. There was no impact to erectile function. 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 | 0.021 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".