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

• Sponsor: Istanbul Medeniyet University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04617743
• Collaborator: (none)
• Enrollment: 500
• Locations: 3
• Anticipated Duration (Months): 23.2
• Patients Per Site: 166.7
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Recurrent; Non-Invasive Bladder Urothelial Carcinoma

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 [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression
• Actual Study Start Date: Nov 26, 2020
• Actual Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
High residual volume Bladder tumor patients with high residual volume
Low residual volume Bladder tumor patients with low residual volume

Outcome Measures

Primary Outcome Measures

1. Recurrence [1 year]

   Non-muscle invasive bladder cancer recurrence rate

Secondary Outcome Measures

1. Progression [1 year]

   Non-muscle invasive bladder cancer progression rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Sciences University, Dıskapi Yildirim Beyazit Training and Research Hospital	Ankara		Turkey
2	Istanbul Medeniyet University	Istanbul		Turkey
3	Health Sciences University, Tepecik Training and Research Hospital	İzmir		Turkey

Sponsors and Collaborators

• Istanbul Medeniyet University

Investigators

• Principal Investigator: Mehmet Caglar Cakici, M.D., Istanbul Medeniyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mehmet Caglar Cakici, Department of Urology, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT04617743
• Other Study ID Numbers: IMU Urology
• First Posted: Nov 5, 2020
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mehmet Caglar Cakici, Department of Urology, Istanbul Medeniyet University: bladder cancer; post voiding residual urine; recurrence; non-muscle invasive bladder cancer; progression
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Disease Progression; Recurrence

Study Results

No Results Posted as of Apr 12, 2022