A Novel Drug Eluting Ureteral Stent

A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of a Ketorolac Loaded Ureteral Stent

Amy Krambeck, Robert S. Walsh, John D. Denstedt, Glenn M. Preminger, Jamie Li, John C. Evans, James E. Lingeman

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Purpose: We evaluated the short-term safety and efficacy of a ketorolac loaded ureteral stent compared to a standard stent (control). Materials and Methods: In this prospective, multicenter, double-blind study patients were randomized 1:1 to ketorolac loaded or control stents after ureteroscopy. The primary end point was an intervention for pain defined as unscheduled physician contact, change in pain medication or early stent removal. Secondary end points included medication use and pain visual analog score. A total of 20 patients underwent serum safety testing for ketorolac levels. Results: None of the safety cohort had detectable serum ketorolac levels. Among the 276 patients there was no difference in primary (9.0% ketorolac loaded vs 7.0% control, p = 0.66) or secondary (22.6% ketorolac loaded vs 25.2% control, p = 0.67) intervention rates. Mean pain pill count at day 3 was lower in the ketorolac loaded stent group than in the control group (p <0.05). A higher number (p = 0.057) of patients with ketorolac loaded (32%) stents used no or limited pain medications compared to controls (22%). A higher number of male patients with ketorolac loaded stents used no pain medication on days 3 and 4 compared to female patients with ketorolac loaded stents, and male and female control patients (p <0.05). Conclusions: The overall safety of the ketorolac loaded stent was confirmed. Although there was no significant difference in primary or secondary intervention rates, a trend toward a treatment benefit was noted for patients receiving drug loaded stents. Specifically young male patients appeared to require less pain medication when the ketorolac loaded stent was used. Future studies with higher drug concentrations or alternative drug eluting stents may prove beneficial.

Original languageEnglish (US)
Pages (from-to)1037-1043
Number of pages7
JournalJournal of Urology
Volume183
Issue number3
DOIs
StatePublished - Mar 2010

Fingerprint

Ketorolac
Drug-Eluting Stents
Multicenter Studies
Stents
Randomized Controlled Trials
Safety
Pain
Ureteroscopy
Serum
Double-Blind Method
Pharmaceutical Preparations

Keywords

  • endoscopy
  • ketorolac
  • pain measurement
  • stents
  • ureteroscopy

ASJC Scopus subject areas

  • Urology

Cite this

A Novel Drug Eluting Ureteral Stent : A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of a Ketorolac Loaded Ureteral Stent. / Krambeck, Amy; Walsh, Robert S.; Denstedt, John D.; Preminger, Glenn M.; Li, Jamie; Evans, John C.; Lingeman, James E.

In: Journal of Urology, Vol. 183, No. 3, 03.2010, p. 1037-1043.

Research output: Contribution to journalArticle

Krambeck, Amy ; Walsh, Robert S. ; Denstedt, John D. ; Preminger, Glenn M. ; Li, Jamie ; Evans, John C. ; Lingeman, James E. / A Novel Drug Eluting Ureteral Stent : A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of a Ketorolac Loaded Ureteral Stent. In: Journal of Urology. 2010 ; Vol. 183, No. 3. pp. 1037-1043.
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abstract = "Purpose: We evaluated the short-term safety and efficacy of a ketorolac loaded ureteral stent compared to a standard stent (control). Materials and Methods: In this prospective, multicenter, double-blind study patients were randomized 1:1 to ketorolac loaded or control stents after ureteroscopy. The primary end point was an intervention for pain defined as unscheduled physician contact, change in pain medication or early stent removal. Secondary end points included medication use and pain visual analog score. A total of 20 patients underwent serum safety testing for ketorolac levels. Results: None of the safety cohort had detectable serum ketorolac levels. Among the 276 patients there was no difference in primary (9.0{\%} ketorolac loaded vs 7.0{\%} control, p = 0.66) or secondary (22.6{\%} ketorolac loaded vs 25.2{\%} control, p = 0.67) intervention rates. Mean pain pill count at day 3 was lower in the ketorolac loaded stent group than in the control group (p <0.05). A higher number (p = 0.057) of patients with ketorolac loaded (32{\%}) stents used no or limited pain medications compared to controls (22{\%}). A higher number of male patients with ketorolac loaded stents used no pain medication on days 3 and 4 compared to female patients with ketorolac loaded stents, and male and female control patients (p <0.05). Conclusions: The overall safety of the ketorolac loaded stent was confirmed. Although there was no significant difference in primary or secondary intervention rates, a trend toward a treatment benefit was noted for patients receiving drug loaded stents. Specifically young male patients appeared to require less pain medication when the ketorolac loaded stent was used. Future studies with higher drug concentrations or alternative drug eluting stents may prove beneficial.",
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AB - Purpose: We evaluated the short-term safety and efficacy of a ketorolac loaded ureteral stent compared to a standard stent (control). Materials and Methods: In this prospective, multicenter, double-blind study patients were randomized 1:1 to ketorolac loaded or control stents after ureteroscopy. The primary end point was an intervention for pain defined as unscheduled physician contact, change in pain medication or early stent removal. Secondary end points included medication use and pain visual analog score. A total of 20 patients underwent serum safety testing for ketorolac levels. Results: None of the safety cohort had detectable serum ketorolac levels. Among the 276 patients there was no difference in primary (9.0% ketorolac loaded vs 7.0% control, p = 0.66) or secondary (22.6% ketorolac loaded vs 25.2% control, p = 0.67) intervention rates. Mean pain pill count at day 3 was lower in the ketorolac loaded stent group than in the control group (p <0.05). A higher number (p = 0.057) of patients with ketorolac loaded (32%) stents used no or limited pain medications compared to controls (22%). A higher number of male patients with ketorolac loaded stents used no pain medication on days 3 and 4 compared to female patients with ketorolac loaded stents, and male and female control patients (p <0.05). Conclusions: The overall safety of the ketorolac loaded stent was confirmed. Although there was no significant difference in primary or secondary intervention rates, a trend toward a treatment benefit was noted for patients receiving drug loaded stents. Specifically young male patients appeared to require less pain medication when the ketorolac loaded stent was used. Future studies with higher drug concentrations or alternative drug eluting stents may prove beneficial.

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