Not muscular invasive bladder cancer
Conditions
Brief summary
proportion of patients with residual tumour and/or new diagnosis of CIS at the time of reTUR (persistent CIS diagnosed at primary TUR will not count as residual tumour) in comparison between PDD and WLC
Detailed description
proportion of CIS and upstaging according to the definition by Lamm et al. at re-TUR, comparative 3-months recurrence rate for patients not undergoing reTUR., proportion of malignant lesions at primary TURB and re-TURB between PDD and WLC utilising high-definition equipment., Proportion of patients with treatment change as a result of additional tumour findings at re-TUR., Quality of life estimated with EQ5DL and the QLQ-NMIBC24 questionnaires performed at the following timepoints: after randomization, 1 month after 1st TURB, 3 months after Re-TURBT for all groups, Adverse events
Interventions
Sponsors
Eligibility
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| proportion of CIS and upstaging according to the definition by Lamm et al. at re-TUR, comparative 3-months recurrence rate for patients not undergoing reTUR., proportion of malignant lesions at primary TURB and re-TURB between PDD and WLC utilising high-definition equipment., Proportion of patients with treatment change as a result of additional tumour findings at re-TUR., Quality of life estimated with EQ5DL and the QLQ-NMIBC24 questionnaires performed at the following timepoints: after randomization, 1 month after 1st TURB, 3 months after Re-TURBT for all groups, Adverse events | — |
Primary
| Measure | Time frame |
|---|---|
| proportion of patients with residual tumour and/or new diagnosis of CIS at the time of reTUR (persistent CIS diagnosed at primary TUR will not count as residual tumour) in comparison between PDD and WLC | — |
Countries
Italy