AUA 2009 - Stone Disease: Research/New Technology - The First Drug Eluting Ureteral Stent: A Prospective, Randomized Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of a Ketorolac-Loaded Ureteral Stent - Session Highlights

CHICAGO, IL, USA (UroToday.com) - In this level I evidence study, 276 patients were randomized to receive a ketorolac impregnated drug eluting stent (13% drug by weight) or a control nondrug eluting stent for up to 10 days.

Prior porcine studies revealed that therapeutic levels of ketorolac were achieved within the wall of the ureter (i.e. traversing the urothelial barrier). Patients were evaluated according to unscheduled office visits, changes in pain medication use, early stent removal due to symptoms, visual analog pain scales, and overall pain medication use. The bottom line is that while the stent was found to be safe, no statistically significant difference in any of the aforementioned parameters was found overall. However, in a subanalysis, among young males there was a statistically significant difference with regard to one area: use of “no” pain medications at post stent placement on days 3 and 4; in females, no differences were noted.

 

The search for the “painless” stent continues. What we still don’t understand is the mechanism for ureteral discomfort in these patients. Is it due to inflammation, spasm, or the simple distention of the ureteral vesical junction due to the mere presence of a stent? Once this is understood perhaps we can better address treatment in a more effective manner. Regardless, this remains an interesting and important first step and the authors are to be congratulated on completing an excellent prospective study to determine the efficacy of this new stent.

 

Presented by James E. Lingeman, MD, et al. at the Annual Meeting of the American Urological Association (AUA) - April 25 - 30, 2009 - McCormick Place Convention Center - Chicago, Illinois, USA.



 

 


The opinions expressed in this article are those of the UroToday.com Contributing Medical Editor and do not necessarily reflect the viewpoints of the American Urological Association.



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