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

NCT ID: NCT04617743

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-26

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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Bladder Cancer Recurrent Non-Invasive Bladder Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High residual volume

Bladder tumor patients with high residual volume

No interventions assigned to this group

Low residual volume

Bladder tumor patients with low residual volume

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Caglar Cakici

Department of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Caglar Cakici, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University

Locations

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Health Sciences University, Dıskapi Yildirim Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Medeniyet University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Health Sciences University, Tepecik Training and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Caglar Cakici, M.D.

Role: CONTACT

+90 5376102438

Facility Contacts

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Nihat Karakoyunlu, Assoc.Prof.

Role: primary

+90 5324747134

Mehmet Caglar Cakici, M.D.

Role: primary

+90 5376102438

Erdem Kısa, Assoc.Prof

Role: primary

+90 5052234221

References

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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):1106-1112. doi: 10.1111/iju.14103. Epub 2019 Sep 14.

Reference Type RESULT
PMID: 31522458 (View on PubMed)

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 carcinoma. Int J Urol. 2020 Nov;27(11):1024-1030. doi: 10.1111/iju.14352. Epub 2020 Sep 1.

Reference Type RESULT
PMID: 32875619 (View on PubMed)

Other Identifiers

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IMU Urology

Identifier Type: -

Identifier Source: org_study_id

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