Multicentre prospective crossover study of the ‘prostatic urethral lift’ for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia
Bibliographic record
Abstract
OBJECTIVE: To assess the clinical effect of the 'prostatic urethral lift' (PUL) on lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) through a crossover design study. PATIENTS AND METHODS: Men aged ≥ 50 years with an International Prostate Symptom Score of ≥ 13, a maximum urinary flow rate (Qmax) of ≤ 12 mL/s, and a prostate of 30-80 mL were enrolled into a crossover study after completing a prospective, randomised, controlled, 'blinded' pivotal study in which they were control subjects receiving a sham procedure. Patients were followed for 1 year after crossover PUL at 19 centres in the USA, Canada and Australia. The sham procedure involved rigid cystoscopy with simulated active treatment sounds. PUL involved placing permanent UroLift® (NeoTract, Inc., Pleasanton, CA, USA) implants into the lateral lobes of the prostate to enlarge the urethral lumen. Urinary symptom relief, health-related quality of life (HRQL) impact, urinary flow parameters, sexual function, and adverse events were assessed and compared between the sham and PUL using paired statistical analysis. RESULTS: Symptom, flow, HRQL and sexual function assessments showed response improvements from baseline results, similar to results from other published studies, and most parameters were markedly improved after PUL vs the sham procedure in the same patients. Symptom, flow, and HRQL improvements were durable over the 12 months of the study. Adverse events associated with the procedure were typically transient and mild to moderate; one patient (2%) required re-intervention with transurethral resection of the prostate in the first year. There were no occurrences of de novo, sustained ejaculatory or erectile dysfunction. CONCLUSION: The PUL can be performed under local anaesthesia, causes minimal associated perioperative complications, allows patients to quickly return to normal activity, provides rapid and durable improvement in symptoms, and preserves sexual function.
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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 | 0.008 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".