Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Distilled Water vs Mitomycin C as a Single Dose Immediate Instillation After Transurethral Resection of Intermediate Risk, Recurrent Superficial Bladder Cancer

Conditions
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Recurrent Superficial Bladder Cancer, Distilled Water

Intervention / Treatment
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* Drug: distilled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: carcinoma in situ any form of intracavitary maintenance therapy any form of bladder cancer other than transitional cell type
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1, Distilled water<br>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<br>* we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor recurrence by cystoscopic examination, urine and bladder wash cytology |  | within two years after instillation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distilled water, recurrent, bladder, mitomycin