Bladder Cancer RecurrentNCT04617743
The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression
An observational study of Bladder Cancer Recurrent and Non-Invasive Bladder Urothelial Carcinoma, run by Istanbul Medeniyet University at 3 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer Recurrent, Non-Invasive Bladder Urothelial Carcinoma
- How many people
- 500 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 26 Nov 2020to 1 Nov 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with transitional cell non-muscle invasive bladder cancer pathology and patients with follow-up data
Who may be able to join
- 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
Who cannot join
- Non-transitional cell bladder cancers
- Patients with muscle-invasive bladder cancer pathology
- <18 years old patients
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Health Sciences University, Dıskapi Yildirim Beyazit Training and Research Hospital
Ankara
Istanbul Medeniyet University
Istanbul
Health Sciences University, Tepecik Training and Research Hospital
Izmir
About this study
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.
Read the 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.
- Keywords
- bladder cancer, post voiding residual urine, recurrence, non-muscle invasive bladder cancer, progression
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence, Non-Muscle Invasive Bladder Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High residual volume | Bladder tumor patients with high residual volume | |
| Low residual volume | Bladder tumor patients with low residual volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Non-muscle invasive bladder cancer recurrence rate
Measured: 1 year
Secondary outcomes (1)
Progression
Non-muscle invasive bladder cancer progression rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start26 Nov 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Caglar Cakici, Istanbul Medeniyet University
- Investigators
- Mehmet Caglar Cakici, M.D., Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617743
- Sponsor's protocol ID
- IMU Urology
- Status last verified
- Jul 2026
- First submitted
- 2 Nov 2020
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31522458Sazuka 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.
PubMed 32875619
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression
- ClinicalTrials.gov ID
- NCT04617743
- Acronym / sponsor ID
- IMU Urology
- Keywords
- bladder cancer, post voiding residual urine, recurrence, non-muscle invasive bladder cancer, progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High residual volume | – | –Bladder tumor patients with high residual volume |
| Low residual volume | – | –Bladder tumor patients with low residual volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with transitional cell non-muscle invasive bladder cancer pathology and patients with follow-up data
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Non-transitional cell bladder cancers
- Patients with muscle-invasive bladder cancer pathology
- <18 years old patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence
Time frame: 1 year
Non-muscle invasive bladder cancer recurrence rate
1 secondary outcome
Progression
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 31522458Sazuka 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.
- Results publication: PubMed 32875619Sazuka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Caglar Cakici, M.D. principal investigator
Istanbul Medeniyet University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer Recurrent and Non-Invasive Bladder Urothelial Carcinoma, run by Istanbul Medeniyet University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.