Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04194112

Enrollment

198

Registered

2019-12-11

Start date

2015-04-01

Completion date

2019-09-01

Last updated

2019-12-12

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

Conditions

Bladder Cancer

Brief summary

The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Detailed description

The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Interventions

DIAGNOSTIC_TESTimmediate urine cytology

Forty-eight hours after primary TURBT, IUC was retrieved and patients were scheduled for repeat TURBT 2 to 6 weeks later according to the predetermined protocol. The primary outcome was to determine the role of positive IUC to predict positive biopsy findings on repeat TURBT.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

-patients with primary or recurrent NMIBC for whom complete TURBT was done

Exclusion criteria

-Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of IUC	It was assessed 48 hours after primary TURBT	The primary outcome included assessment of the performance of IUC as a predictive tool for possible residual malignancy after primary TURBT. Thereafter, sensitivity (Sn), specificity (Sp), positive and negative predictive values (PPV, NPV) and overall accuracy of IUC as a preliminary step before repeat TURBT will be determined.

Secondary

Measure	Time frame	Description
The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.	Within duration of follow up (4 years )	The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026