Two‐year outcomes for the Altis<sup>®</sup> adjustable single incision sling system for treatment of stress urinary incontinence
Bibliographic record
Abstract
AIMS: Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months. METHODS: This was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6-months. Device- and procedure-related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, and Patient Global Impression of Improvement. RESULTS: Of the 113 women implanted, 94 remained at 24-months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow-up data at 24-months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory (P-value <0.0001) and 52.0 in Incontinence Impact Questionnaire scores (P-value <0.0001) were observed. Additionally, 90.4% (85/94) of subjects reported "very much better" or "much better" on the Patient Global Impression of Improvement. No new device- or procedure-related adverse events occurred between the 12 and 24 month visits. CONCLUSIONS: The Altis single-incision sling is a durable and effective treatment with a favorable safety profile for surgical treatment of women with stress or stress-predominant mixed urinary incontinence.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".