Combination of Cystistat and pirarubicin intravesical instillation in reducing intravesical chemotherapy complications： a multi-center clinical study

Abstract

Objective To verify the efficacy and safety of intravesical instillation of Cystistat in reducing complications caused by intravesical chemotherapy after TUR-BT in non-muscle invasive bladder cancer patients. Methods One hundred and twenty patients who met the inclusion/exclusion criteria were enrolled into this multi-centered, randomized and blank controlled clinical study. Selected patients were randomized into the observation group and control group. TUR-BT was carried out in both groups followed by pirarubicin （THP） and Cystistat intravesical instillation in the observationgroup, and THP intravesical instillation alone in control group. Visual analog scale （VAS） was used as the primary efficacy variable. The secondary efficacy variables were assessments of hematuria and bladder irritation symptoms. Adverse events, laboratory tests and changes of vital signs before and af ter treatment were strictly observed during observation to evaluate the efficacy and safety of Cystistat. Results Demographics and baseline characteristics were comparable in both groups. The differences and the improvement rate of VAS score in the 2 groups were significant, both P〈0.01. The changes of VAS score and the improvement rate before and after treatment were （2.24±1.70） and （92.92± 14.76）% in observation group and （0.70±1.82） and （20.59±87.34） % in control group respectively. According to the covarianee analysis, there were significant differences in changes of VAS score between the observation group and the control group. Also, the improvement rate of VAS score was significant from visit 2. The urine frequency decreased from 9.06 ± 4.09 to 6.69 ±2.89 in observation group and increased from 8.85±3.32 to 10. 15±4.40 in control group, P〈0.01. There were also significant differences in changes of nocturia before and after treatment between these two groups （P〈0.01）, the nocturia decreased from 2.88±1.74 to 1.47±1.62 in observation group and 3.22± 2.30 to 2.91 ± 1.73 in control group, respectively. The changes of WHO assessment for hematuria, urgency and dysuria were not significantly different between the 2 groups. No Cystistat related adverse event was observed. Conclusions Cystistat combined instillation can significantly improve the VAS score of patients with chemotherapeutic agent instillation. Relief of bladder pain, frequency and noctu ria are more rapidly and more durable in Cystistat combined instillation group. The improvement is more effective in patients with a high VAS score. Cystistat instillation with chemotherapeutics agents is both well tolerated and safe. Key words: Cystistat; Sodium hyaluronate; Urinary bladder neoplasms; TURBt; Chemotberapy