Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection
Recruitment status was Active, not recruiting
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.
Recurrent Superficial Bladder Cancer
Drug: distilled water
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
|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|
- tumor recurrence by cystoscopic examination, urine and bladder wash cytology [ Time Frame: within two years after instillation ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|