Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	Not specified	Other	URO-DW-1971 NCT00816075

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Bozyaka Training and Research Hospital

Zafer Kozacioglu, MD

Principal Investigator

Murat Arslan, MD

Study Chair

Tansu Degirmenci, MD

Study Chair

Fatih Duz, MD

Study Chair

Ali R Ayder, MD

Study Director

Nukhet Eliyatkin, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00816075
Information obtained from ClinicalTrials.gov on March 18, 2009