An <i>In Vivo</i> Porcine Evaluation of the Safety, Bioavailability, and Tissue Penetration of a Ketorolac Drug-Eluting Ureteral Stent Designed to Improve Comfort
Bibliographic record
Abstract
BACKGROUND AND PURPOSE: Ureteral stents often cause significant patient morbidity that can be difficult to treat. Drug-eluting stent technology allows the local delivery of a drug. Our previous work demonstrated that ketorolac instilled intravesically at the time of ureteral stent insertion significantly decreased flank pain compared with controls. We sought to determine the safety of a novel ketorolac-eluting ureteral stent. MATERIALS AND METHODS: A total of 92 Yorkshire pigs were randomized to 1 of 5 groups. The oral control group consisted of 12 animals with transurethrally inserted control ureteral stents and 5 days of oral ketorolac. Twenty animals in each of the remaining groups received a control stent, or 15%, 13%, or 7% ketorolac-loaded stents. Ketorolac levels were measured in plasma, urine, and tissue sampled from ureters, bladder, kidneys, and liver using high performance liquid chromatography. Necropsies were performed to evaluate tissue pathology. RESULTS: The majority of ketorolac was released within the first 30 days. The highest levels of ketorolac in plasma, kidney, and liver occurred in the oral control group. The highest levels of ketorolac found in ureteral and bladder tissues occurred in the ketorolac-stent groups in a dose-dependent fashion. No adverse events were noted in any of the ketorolac-stent groups. Gastric ulcerations were identified only in the oral control group. No abnormalities were identified in any other internal organs in any group. CONCLUSIONS: The use of ketorolac-eluting ureteral stents has proven to be safe in a porcine model. The ketorolac-stent group had less than 12% of the ketorolac concentration in plasma, kidney, and liver tissues compared with the oral ketorolac group. Ureteral tissues displayed the highest levels of ketorolac. Clinical studies are needed to determine if ketorolac-elution reduces stent symptoms.
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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 | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 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".