12-Month Outcomes From a Randomized, Sham-Controlled Trial Evaluating a Novel Prostatic Urethral Stent for the Treatment of Benign Prostatic Hyperplasia
Bibliographic record
Abstract
PURPOSE: The ProVee System for benign prostatic hyperplasia is a new generation permanent prostatic urethral stent for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. ProVIDE is a prospective, randomized, double-blind, sham-controlled study evaluating the safety and effectiveness of ProVee against a sham procedure. MATERIALS AND METHODS: Men at least aged 45 years were eligible for the study if they had International Prostate Symptom Score ≥ 13, peak urinary flow rate < 12 mL/s, prostate volume 30 to 80 cc, and prostatic urethral length ≥3.75 cm. Primary effectiveness endpoints were a mean improvement in International Prostate Symptom Score at 3 months and 12 months. Symptomatic improvement, uroflowmetry, quality of life, and sexual function were assessed at follow-up. RESULTS: = .002). There were no device-related or procedure-related serious adverse events through 12 months, and no incidence of de novo sustained retrograde ejaculation or erectile dysfunction. CONCLUSIONS: Treatment with ProVee was reliably performed and resulted in a statistically superior improvement in International Prostate Symptom Score at 3 months compared with a sham procedure with sustained response at 12 months. CLINICAL TRIAL REGISTRATION NUMBER: NCT05186740.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".