Clinical trial NCT04617743: The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression
Official title: The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer Recurrent
Non-Invasive Bladder Urothelial Carcinoma
Keywords: bladder cancer
post voiding residual urine
recurrence
non-muscle invasive bladder cancer
progression
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with transitional cell non-muscle invasive bladder cancer pathology and patients with follow-up data

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Progression
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Sciences University, Dıskapi Yildirim Beyazit Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
city: İzmir
country: Turkey
facility: Health Sciences University, Tepecik Training and Research Hospital
Study officials:
affiliation: Istanbul Medeniyet University
name: Mehmet Caglar Cakici, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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):1106-1112. doi: 10.1111/iju.14103. Epub 2019 Sep 14.
citation: 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.