A novel drug eluting ureteral stent: a prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a ketorolac loaded ureteral stent.

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.