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The impact of PDD during TURB for NMIBC: a prospective randomized controlled trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514316-27-00
Acronym
CDS01FS
Enrollment
300
Registered
2025-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not muscular invasive bladder cancer

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

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026