Overview

This trial is active, not recruiting.

Conditions recurrent superficial bladder cancer, distilled water
Treatment 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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (caregiver)
Primary purpose prevention
Arm
(Experimental)
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
distilled water
we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours

Primary Outcomes

Measure
tumor recurrence by cystoscopic examination, urine and bladder wash cytology
time frame: within two years after instillation

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Bozyaka Training and Research Hospital.