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

Not Applicable

Recruiting

Conditions: Neoplasms

Registration Number: KCT0000498

Lead Sponsor: ational Cancer Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 172

Inclusion Criteria

Patients undergoing transurethral resection of the bladder tumor under general or spinal anaesthesia

Exclusion Criteria

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