5 - One-Year Outcomes of the Optilume® Urethral Drug-Coated Balloon for the Treatment of Benign Prostatic Hyperplasia
Bibliographic record
Abstract
Hypothesis / aims of study The Optilume® drug-coated balloon (DCB) represents an innovative therapy for lower urinary tract symptoms (LUTS), integrating mechanical dilation for prompt symptom improvement with targeted paclitaxel delivery. This study examines the safety profile and functional outcomes of the Optilume BPH catheter system in one year. Study design, materials and methods This prospective, single-arm, multi-center, open-label study will be conducted at Canadian centers with 24 patients to evaluate the safety of the endoscopic Optilume BPH drug-coated balloon procedure for LUTS due to BPE from July 2022 to January 2025. The study will assess the complication rate at 90 days and evaluate functional outcomes at baseline, 3, 6, and 12 months. Results Out of 24 patients, 17 (70.8%) experienced a total of 42 adverse events (AEs), the majority of which were mild (Grade I: 70.8%). The most reported side effects were hematuria (41.6%), dysuria (16.6%), urinary tract infection (UTI) (8.4%), and urinary urgency (8.4%). Significant symptomatic improvement was observed over time. IPSS scores decreased from 22.5 ± 5.1 at baseline to 11 ± 6.6 at 12 months, while QoL scores improved from 4.6 ± 1.3 to 1.9 ± 1.4 over the same period. Qmax increased from 9.4 ± 3.6 mL/s to 15.7 ± 4.9 mL/s at 3 months, remaining stable at 15.3 ± 7.7 mL/s at 12 months. Post-void residual (PVR) volume decreased from 96.3 ± 83.9 mL to 68.1 ± 43.9 mL at 12 months, reflecting sustained improvements in urinary function. No significant differences were observed in sexual function scores, including IIEF, MSHQ function, and bother scores, indicating that the procedure did not negatively impact sexual health Interpretation of results The Optilume BPH drug-coated balloon procedure demonstrated significant symptomatic and functional improvements while maintaining a favorable safety profile over 12 months. Most adverse events were mild and self-limiting, with no serious complications or need for surgical intervention. Improvements in IPSS, QoL, Qmax, and PVR were sustained over time, and sexual function remained stable. Concluding message These findings support Optilume BPH as an effective and well-tolerated minimally invasive treatment for BPH-related LUTS. Funding No funding Clinical Trial Yes Registration Number The SUMMIT study RCT No Subjects Human Helsinki Yes Informed Consent Yes
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".