Effect of solifenacin for prevention of catheter related bladder discomfort after transurethral resection of bladder tumor in bladder cancer patients: multicenter, randomized, prospective, 2 group clinical trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 172
研究概览
简要总结
Background: Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is worse after transurethral resection of a bladder tumor (TUR-BT). We evaluated the incidence of CRBD and the efficacy of solifenacin for preventing CRBD after TUR-BT in patients with non-muscle invasive bladder cancer. Patients and Methods: In the present prospective, randomized, multicenter trial, we enrolled 148 patients with non-muscle invasive bladder cancer who underwent elective TUR-BT under general anesthesia. The patients were randomized to group S (n ¼ 72) or group C (n ¼ 76). The primary outcome was evaluable for 134 patients, who were included in the final analysis. Group S received solifenacin (5 mg orally) on the day before, the day, and the day after TUR-BT. The control group (group C) received standard care. CRBD was assessed at 1 and 2 hours postoperatively. Pain was assessed for 3 days starting 6 hours after TUR-BT using the visual analog scale. Results: The incidence rates of CRBD in groups C and S were 72.2% and 64.5% at 1 hour and 68.1% and 53.2% at 2 hours, respectively. The incidence rates and severity of CRBD at 1 and 2 hours were not different between the 2 groups (P > .05 for both). The visual analog scale scores and the postoperative consumption of analgesics were not different between the 2 groups (P > .05 for both). None of the patients who received solifenacin experienced an adverse event. Conclusion: Pretreatment with solifenacin (5 mg) failed to decrease the incidence and severity of CRBD after TUR-BT.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 0No Limit 至 100No Limit(—)
- 性别
- All
入选标准
- •Patients undergoing transurethral resection of the bladder tumor under general or spinal anaesthesia
排除标准
- •1) past analgesics use history,
- •2) anticholinergics user due to OAB,
- •3) brain and spinal disease,
- •4) renal dysfunction,
- •5) hepatic dysfunction,
- •6) can not access the pain,
- •7) postvoiding volume >200cc
- •8) Qmax < 5mml/sec
- •9) clinical stage > T2
- •10) no complete resection case
