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临床试验/KCT0000498
KCT0000498招募中未知

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

ational Cancer Center0 个研究点目标入组 172 人开始时间: 待定最近更新:
适应症

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

研究者

发起方
ational Cancer Center

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