The EXPANDER-1 trial: introduction of the novel Urocross™ Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)
Bibliographic record
Abstract
PURPOSE: To demonstrate the safety and feasibility of the Urocross Expander System (formerly branded as XFLO Expander System), an implantable nitinol tissue expander to trea t patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Men of 50 years or older were eligible to participate in the international, prospective, three-arm, open-label EXPANDER-1 trial if they had a prostate volume between 30 and 80 cc, prostatic urethra length between 20 and 60/80 mm, international prostate symptom score (IPSS) > 13, peak urinary flow (Qmax) < 12 mL/s, post-void residual (PVR) urine volume < 250 mL and quality of life (QoL) score ≥ 3. Patients had pre-assigned implant indwell times (1, 6, and 12 months for Arm-1, Arm-2 and Arm-3 respectively) with follow-up through 6 months (Arm-1) and 3 years (Arm-2 and Arm-3) post-retrieval. RESULTS: Outcome from treated subjects with their 6-month post-retrieval will be presented in this manuscript, as data collection from longer-term follow-up is ongoing. As of May 24, 2021, 39 and 22 men (mean age: 65), respectively, had implants successfully deployed and retrieved without any complications. No cases of implant encrustation were observed. Device- and procedure-related adverse events were predominantly mild to moderate in severity. Three SAEs were reported. Only one patient required catheterization post-implant for more than three days. Improvements in clinical parameters such as IPSS, QoL, PVR and Qmax as well as sexual function were observed. CONCLUSIONS: Preliminary results demonstrate that the Urocross Expander System is a feasible and safe procedure for treating BPH/LUTS. A strong signal of efficacy justifies further evaluation of this PRostatic Urethral Expansion (PURE) procedure. Negative features of earlier generations of prostatic implants such as biocompatibility, migrations and encrustation have possibly been overcome.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".