BACKGROUND AND PURPOSE:Ureteral stents are a significant source of pain and discomfort for many urologic patients. A novel approach to addressing this problem is the intravesical instillation of a selected pharmacologic agent after stent insertion. The purpose of this study was to assess the safety and efficacy of intravesical instillation of various agents in reducing ureteral stent-associated discomfort in patients requiring a stent after extracorporeal shockwave lithotripsy (SWL). PATIENTS AND METHODS: In this double-blind prospective trial, 42 patients were randomized to receive intravesical instillation of one of three agents (oxybutynin, alkalinized lidocaine, or ketorolac) or a control solution (0.9% sodium chloride) immediately after stent insertion at time of SWL. The four groups of patients were demographically similar. Preoperative, intraoperative, and postoperative data were collected prospectively and analyzed statistically. The primary outcome measure was reduction in ureteral stent symptoms, and the secondary outcome measure was the safety of intravesical instillation of each agent through assessment of drug-related adverse events. RESULTS: There were no intraoperative or postoperative complications, nor were there any serious side effects attributable to any of the intravesically instilled agents. There was a statistically significant decrease in stent-related discomfort at the 1-hour time point in the group of patients who received intravesical ketorolac compared with the control group. CONCLUSIONS: Intravesical instillation represents a novel approach to the problem of ureteral stent-related discomfort. From our results, ketorolac appears to be the most effective intravesical agent in reducing stent-related patient discomfort, and we have established that intravesical instillation of ketorolac is safe in humans.
RCT Entities:
BACKGROUND AND PURPOSE: Ureteral stents are a significant source of pain and discomfort for many urologic patients. A novel approach to addressing this problem is the intravesical instillation of a selected pharmacologic agent after stent insertion. The purpose of this study was to assess the safety and efficacy of intravesical instillation of various agents in reducing ureteral stent-associated discomfort in patients requiring a stent after extracorporeal shockwave lithotripsy (SWL). PATIENTS AND METHODS: In this double-blind prospective trial, 42 patients were randomized to receive intravesical instillation of one of three agents (oxybutynin, alkalinized lidocaine, or ketorolac) or a control solution (0.9% sodium chloride) immediately after stent insertion at time of SWL. The four groups of patients were demographically similar. Preoperative, intraoperative, and postoperative data were collected prospectively and analyzed statistically. The primary outcome measure was reduction in ureteral stent symptoms, and the secondary outcome measure was the safety of intravesical instillation of each agent through assessment of drug-related adverse events. RESULTS: There were no intraoperative or postoperative complications, nor were there any serious side effects attributable to any of the intravesically instilled agents. There was a statistically significant decrease in stent-related discomfort at the 1-hour time point in the group of patients who received intravesical ketorolac compared with the control group. CONCLUSIONS: Intravesical instillation represents a novel approach to the problem of ureteral stent-related discomfort. From our results, ketorolac appears to be the most effective intravesical agent in reducing stent-related patient discomfort, and we have established that intravesical instillation of ketorolac is safe in humans.