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

Non-Invasive Bladder Urothelial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617743
• Other study ID #: IMU Urology
• Status: Recruiting
• Start date: November 26, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2022
• Source: Istanbul Medeniyet University
• Contact: Mehmet Caglar Cakici, M.D.
• Phone: +90 5376102438
• Email: mcaglarcakici[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer Recurrent
• Disease Progression
• Non-Invasive Bladder Urothelial Carcinoma
• Recurrence
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Turkey	Health Sciences University, Diskapi Yildirim Beyazit Training and Research Hospital	Ankara
Turkey	Istanbul Medeniyet University	Istanbul
Turkey	Health Sciences University, Tepecik Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Sazuka T, Sakamoto S, Imamura Y, Nakamura K, Yamamoto S, Arai T, Takeuchi N, Komiya A, Teishima J, Ichikawa T. Relationship between post-void residual urine volume, preoperative pyuria and intravesical recurrence after transurethral resection of bladder c — View Citation

Sazuka T, Sakamoto S, Nakamura K, Imamura Y, Yamamoto S, Komiya A, Ichikawa T. Impact of post-void residual urine volume on intravesical recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma. Int J Urol. 2019 Dec;26(12):1106-111 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Non-muscle invasive bladder cancer recurrence rate	1 year
Secondary	Progression	Non-muscle invasive bladder cancer progression rate	1 year