NCT04617743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

November 26, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

November 2, 2020

Last Update Submit

April 10, 2022

Conditions

Bladder Cancer RecurrentNon-Invasive Bladder Urothelial Carcinoma

Keywords

bladder cancerpost voiding residual urinerecurrencenon-muscle invasive bladder cancerprogression

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Non-muscle invasive bladder cancer recurrence rate

    1 year

Secondary Outcomes (1)

  • Progression

    1 year

Study Arms (2)

High residual volume

Bladder tumor patients with high residual volume

Low residual volume

Bladder tumor patients with low residual volume

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with transitional cell non-muscle invasive bladder cancer pathology and patients with follow-up data

You may qualify if:

  • 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

You may not qualify if:

  • Non-transitional cell bladder cancers
  • Patients with muscle-invasive bladder cancer pathology
  • \<18 years old patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Health Sciences University, Dıskapi Yildirim Beyazit Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

RECRUITING

Health Sciences University, Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31522458RESULT

  • 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.

    PMID: 32875619RESULT

MeSH Terms

Conditions

Urinary Bladder NeoplasmsRecurrenceNon-Muscle Invasive Bladder NeoplasmsDisease Progression

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Mehmet Caglar Cakici, M.D.

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Caglar Cakici, M.D.

CONTACT

+90 5376102438mcaglarcakici@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Urology

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 5, 2020

Study Start

November 26, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(3)