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

• Conditions: Non-Invasive Bladder Urothelial Carcinoma; Bladder Cancer Recurrent

• Registration Number: NCT04617743
• Lead Sponsor: Istanbul Medeniyet University

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 Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-05
• Study Start: 2020-11-26
• Primary Completion: 2021-11-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-10
• Last Update Posted: 2022-04-12
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence	1 year	Non-muscle invasive bladder cancer recurrence rate

Secondary Outcome Measures

Name	Time	Method
Progression	1 year	Non-muscle invasive bladder cancer progression rate

Trial Locations

Locations (3)

Health Sciences University, Dıskapi Yildirim Beyazit Training and Research Hospital; 🇹🇷 Ankara, Turkey

Health Sciences University, Tepecik Training and Research Hospital; 🇹🇷 İzmir, Turkey

Istanbul Medeniyet University; 🇹🇷 Istanbul, Turkey