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Clinical Trials/NCT04617743
NCT04617743CompletedNot Applicable

The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression

Istanbul Medeniyet University6 sites in 2 countries500 target enrollmentStarted: November 26, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
500
Locations
6
Primary Endpoint
Recurrence

Study Overview

Brief Summary

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

Detailed Description

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. Participants who underwent transurethral resection for bladder tumor will be included in the study. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with transitional cell non-muscle invasive bladder cancer (NMIBC) pathology
  • Patients with a diagnosis of Bladder cancer (NMIBC)
  • Patients undergoing transurethral resection for bladder cancer (NMIBC)
  • ≥18 years old patients

Exclusion Criteria

  • Non-transitional cell bladder cancers
  • Patients with muscle-invasive bladder cancer pathology
  • <18 years old patients

Arms & Interventions

Low residual volume

Bladder tumor patients with low residual volume

High residual volume

Bladder tumor patients with high residual volume

Outcomes

Primary Outcomes

Recurrence

Time Frame: 1 year

Non-muscle invasive bladder cancer recurrence rate

Secondary Outcomes

  • Progression(1 year)

Investigators

Sponsor
Istanbul Medeniyet University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Caglar Cakici

Department of Urology

Istanbul Medeniyet University

Study Sites (6)

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