Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection
|ClinicalTrials.gov Identifier: NCT00816075|
Recruitment Status : Unknown
Verified February 2009 by Bozyaka Training and Research Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 31, 2008
Last Update Posted : February 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Superficial Bladder Cancer Distilled Water||Drug: distilled water||Phase 2 Phase 3|
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;
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|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|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||April 2011|
Experimental: 1, Distilled water
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
Drug: distilled water
we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours
- tumor recurrence by cystoscopic examination, urine and bladder wash cytology [ Time Frame: within two years after instillation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816075
|Bozyaka Training and Research Hospital Urology Clinic|
|Principal Investigator:||Zafer Kozacioglu, MD||Bozyaka Trainig and Research Hospital Urology Clinic|
|Study Chair:||Murat Arslan, MD||Bozyaka Training and Research Hospital Urology Clinic|
|Study Chair:||Tansu Degirmenci, MD||Bozyaka Training and Research Hospital Urology Clinic|
|Study Chair:||Fatih Duz, MD||Bozyaka Training and Research Hospital Urology Clinic|
|Study Director:||Ali R Ayder, MD||Bozyaka Training and Research Hospital Urology Clinic|
|Study Chair:||Nukhet Eliyatkin, MD||Bozyaka Training and Research Hospital Pathology Clinic|