Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection
This trial is active, not recruiting.
|Conditions||recurrent superficial bladder cancer, distilled water|
|Phase||phase 2/phase 3|
|Sponsor||Bozyaka Training and Research Hospital|
|Start date||February 2009|
|End date||January 2011|
|Trial size||40 participants|
|Trial identifier||NCT00816075, URO-DW-1971|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (caregiver)|
tumor recurrence by cystoscopic examination, urine and bladder wash cytology
time frame: within two years after instillation
Male or female participants of any age.
- 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.
- carcinoma in situ
- any form of intracavitary maintenance therapy
- any form of bladder cancer other than transitional cell type
|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|
|Principal investigator||Zafer Kozacioglu, MD|
|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.|
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