PURPOSE: The purpose of this study was to compare the efficacy of tolterodine and gabapentin vs placebo in catheter related bladder discomfort (CRBD) following percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS: This study was a double-blind parallel group randomized clinical trial. Patients who were candidates of PCNL were enrolled. Patients were randomized to treatment groups of tolterodine 2 mg orally (PO) (group T, n = 50), gabapentin 600 mg PO (group G, n = 50), and placebo (group P, n = 70) 1 hour before operation using balanced block randomization. The primary endpoint of interest was visual analog pain scale in 1, 3, 12, and 24 hours after the operation. Secondary endpoints included rescue analgesic use (opioid and nonopioid). RESULTS: The frequency of severe CRBD in 1,12, and 24 hours after the operation was 4%, 4%, and 6% in group T vs 4%, 0%, and 2% in group G vs 47%, 14%, and 6% in the P group (p < 0.001). The number of paracetamol injections for CRBD in the T and G groups was significantly lower than the placebo group (1.8 ± 0.8 vs 1.8 ± 0.7 vs 3.6 ± 0.7, p < 0.001). Likewise the number of pethidine injections in the T and G groups was significantly lower than the placebo group (0.42 ± 0.54 vs 0.68 ± 0.62 vs 2.4 ± 0.64, p < 0.001). In patients with history of Double-J insertion, the severity of CRBD was lower in all treatment groups. CONCLUSIONS: Preoperative administration of oral tolterodine or gabapentin reduces postoperative CRBD and the need for rescue analgesics as much as 24 hours after surgery. Patients with history of Double-J insertion experience less CRBD.
RCT Entities:
PURPOSE: The purpose of this study was to compare the efficacy of tolterodine and gabapentin vs placebo in catheter related bladder discomfort (CRBD) following percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS: This study was a double-blind parallel group randomized clinical trial. Patients who were candidates of PCNL were enrolled. Patients were randomized to treatment groups of tolterodine 2 mg orally (PO) (group T, n = 50), gabapentin 600 mg PO (group G, n = 50), and placebo (group P, n = 70) 1 hour before operation using balanced block randomization. The primary endpoint of interest was visual analog pain scale in 1, 3, 12, and 24 hours after the operation. Secondary endpoints included rescue analgesic use (opioid and nonopioid). RESULTS: The frequency of severe CRBD in 1,12, and 24 hours after the operation was 4%, 4%, and 6% in group T vs 4%, 0%, and 2% in group G vs 47%, 14%, and 6% in the P group (p < 0.001). The number of paracetamol injections for CRBD in the T and G groups was significantly lower than the placebo group (1.8 ± 0.8 vs 1.8 ± 0.7 vs 3.6 ± 0.7, p < 0.001). Likewise the number of pethidine injections in the T and G groups was significantly lower than the placebo group (0.42 ± 0.54 vs 0.68 ± 0.62 vs 2.4 ± 0.64, p < 0.001). In patients with history of Double-J insertion, the severity of CRBD was lower in all treatment groups. CONCLUSIONS: Preoperative administration of oral tolterodine or gabapentin reduces postoperative CRBD and the need for rescue analgesics as much as 24 hours after surgery. Patients with history of Double-J insertion experience less CRBD.