First Use of the FloStent™ for Catheter-dependent Urinary Retention Secondary to Benign Prostatic Hyperplasia: Additional Results From the RAPID I Study
Bibliographic record
Abstract
OBJECTIVE: To describe the performance of the FloStent™ in men with catheter-dependent urinary retention due benign prostatic hyperplasia (BPH) awaiting transurethral resection of the prostate (TURP). The FloStent™ is a novel device for treatment of BPH, that can be implanted and retrieved with any flexible cystoscope. METHODS: The RAPID I study was a first-in-human clinical trial designed to evaluate the clinical performance of the FloStent™. One arm of the study treated men with lower urinary tract symptoms. In a separate and distinct arm of the study, reported here, 11 men with BPH-related urinary retention and indwelling catheters were enrolled and scheduled for FloStent™ implantation. All underwent outpatient device placement. Follow-up visits occurred at 2, 6, and 12weeks, after which the device was removed, and subjects underwent TURP as previously indicated. RESULTS: All 11 participants achieved catheter-free status immediately postprocedure. Baseline characteristics included mean age 69.0years, prostate size 65.3 mL, prostate-specific antigen 8.3ng/mL, serum creatinine 1.0mg/dL, and prostatic urethral length 3.4 cm. At 3months, 8 of 11 (72.7%) remained catheter-free. Among those, mean International Prostate Symptom Score was 6.4 ± 6.6, Quality of Life score 0.75 ± 1.75, Qmax 9.5 ± 4.8mL/s, and postvoid residual 105.4 ± 265.1 mL. Pain scores were uniformly 0 across all timepoints. Seven adverse events occurred in five subjects, all nonserious and self-limited. CONCLUSION: FloStent™ enabled catheter-free voiding in the majority of subjects, with excellent tolerability. This approach may offer an effective interim solution for patients awaiting TURP.
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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 | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".