Distilled Water Clinical Trial
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
Verified date | February 2009 |
Source | Bozyaka Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | April 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Bozyaka Training and Research Hospital Urology Clinic | Izmir |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | tumor recurrence by cystoscopic examination, urine and bladder wash cytology | within two years after instillation | Yes |