Recurrent Superficial Bladder CancerPhase 2/3NCT00816075
Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection
A Phase 2/3 study testing distilled water in people with Recurrent Superficial Bladder Cancer and Distilled Water, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare and evaluate the efficacy of distilled water vs Mitomycin C on preventing the recurrences of intermediate risk group recurrent superficial bladder cancer administered as a single dose immediate instillation after complete Transurethral Resection(TUR) of the tumor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Superficial Bladder Cancer, Distilled Water
- What is being tested?
- distilled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2009to Apr 2011
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pathologic finding of superficial bladder cancer within the intermediate risk group
- recurred after 6 months from the primary tumor
- those patients who were included in our follow-up program since 2002 and whose records could be obtained.
Who cannot join
- carcinoma in situ
- any form of intracavitary maintenance therapy
- any form of bladder cancer other than transitional cell type
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bozyaka Training and Research Hospital Urology Clinic
Izmir
About this study
Official title: The Efficacy of Distilled Water vs Mitomycin C as a Single Dose Immediate Instillation After Transurethral Resection of Intermediate Risk, Recurrent Superficial Bladder Cancer
The purpose of this study is to compare and evaluate the efficacy of distilled water vs Mitomycin C on preventing the recurrences of intermediate risk group recurrent superficial bladder cancer administered as a single dose immediate instillation after complete Transurethral Resection(TUR) of the tumor.
Read the detailed description
We plan to administer 200ml of distilled water as a single peroperative instillation and block the catheter for 2 hours to our eligible recurrent superficial bladder cancer patients who were in our follow-up schedule since 2002.
We plan to look over the histories of the same patients in terms of the pathologies, recurrence patterns, the presence of peroperative intracavitary therapy after their previous TURs for recurrences.
So we shall compare the effectiveness of MMC and distilled water on reducing the recurrences over the same patient pool.
The patients will be scheduled for a follow-up program after TUR as;
- cystoscopy
- urine cytology
- bladder wash cytology for the probability of recurrence for 2 years to see if there is any difference in the recurrence patterns after instillation with distilled water vs MMC.
- Being tested
- distilled water
- Keywords
- distilled water, recurrent, bladder, mitomycin
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distilled waterDrug
we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| 1, Distilled water | Experimental | the group of patients with superficial bladder cancer in the intermediate risk group who had their first recurrence after 6 months from the initial TUR. We plan to administer 200 ml of distilled water as immediate instillation for 2 hours Receives: Drug: distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor recurrence by cystoscopic examination, urine and bladder wash cytology
Measured: within two years after instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Superficial Bladder CancerStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Zafer Kozacioglu, MD, Principal investigator, Bozyaka Trainig and Research Hospital Urology ClinicMurat Arslan, MD, Study chair, Bozyaka Training and Research Hospital Urology ClinicTansu Degirmenci, MD, Study chair, Bozyaka Training and Research Hospital Urology ClinicFatih Duz, MD, Study chair, Bozyaka Training and Research Hospital Urology ClinicAli R Ayder, MD, Study director, Bozyaka Training and Research Hospital Urology ClinicNukhet Eliyatkin, MD, Study chair, Bozyaka Training and Research Hospital Pathology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816075
- Sponsor's protocol ID
- URO-DW-1971
- Status last verified
- Feb 2009
- First submitted
- 30 Dec 2008
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Distilled Water vs Mitomycin C as a Single Dose Immediate Instillation After Transurethral Resection of Intermediate Risk, Recurrent Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT00816075
- Acronym / sponsor ID
- URO-DW-1971
- Keywords
- distilled water, recurrent, bladder, mitomycin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 31 Dec 2008 (estimated)
- 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.
The purpose of this study is to compare and evaluate the efficacy of distilled water vs Mitomycin C on preventing the recurrences of intermediate risk group recurrent superficial bladder cancer administered as a single dose immediate instillation after complete Transurethral Resection(TUR) of the tumor.
Detailed description
We plan to administer 200ml of distilled water as a single peroperative instillation and block the catheter for 2 hours to our eligible recurrent superficial bladder cancer patients who were in our follow-up schedule since 2002.
We plan to look over the histories of the same patients in terms of the pathologies, recurrence patterns, the presence of peroperative intracavitary therapy after their previous TURs for recurrences.
So we shall compare the effectiveness of MMC and distilled water on reducing the recurrences over the same patient pool.
The patients will be scheduled for a follow-up program after TUR as;
- cystoscopy
- urine cytology
- bladder wash cytology for the probability of recurrence for 2 years to see if there is any difference in the recurrence patterns after instillation with distilled water vs MMC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, Distilled water | Experimental | Drug: distilled waterthe group of patients with superficial bladder cancer in the intermediate risk group who had their first recurrence after 6 months from the initial TUR. We plan to administer 200 ml of distilled water as immediate instillation for 2 hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- pathologic finding of superficial bladder cancer within the intermediate risk group
- recurred after 6 months from the primary tumor
- those patients who were included in our follow-up program since 2002 and whose records could be obtained.
Key exclusion criteria (3 listed)
- carcinoma in situ
- any form of intracavitary maintenance therapy
- any form of bladder cancer other than transitional cell type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distilled waterwe plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours | Drug | 1, Distilled water |
Primary outcome
tumor recurrence by cystoscopic examination, urine and bladder wash cytology
Time frame: within two years after instillation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2009.
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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.
Zafer Kozacioglu, MD principal investigator
Bozyaka Trainig and Research Hospital Urology Clinic
Murat Arslan, MD study chair
Bozyaka Training and Research Hospital Urology Clinic
Tansu Degirmenci, MD study chair
Bozyaka Training and Research Hospital Urology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing distilled water in people with Recurrent Superficial Bladder Cancer and Distilled Water, run by Bozyaka Training and Research Hospital at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
tumor recurrence by cystoscopic examination, urine and bladder wash cytology (time frame: within two years after instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2009.