Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection
Information source: Bozyaka Training and Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Superficial Bladder Cancer; Distilled Water
Intervention: distilled water (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Bozyaka Training and Research Hospital Official(s) and/or principal investigator(s): Zafer Kozacioglu, MD, Principal Investigator, Affiliation: Bozyaka Trainig and Research Hospital Urology Clinic Murat Arslan, MD, Study Chair, Affiliation: Bozyaka Training and Research Hospital Urology Clinic Tansu Degirmenci, MD, Study Chair, Affiliation: Bozyaka Training and Research Hospital Urology Clinic Fatih Duz, MD, Study Chair, Affiliation: Bozyaka Training and Research Hospital Urology Clinic Ali R Ayder, MD, Study Director, Affiliation: Bozyaka Training and Research Hospital Urology Clinic Nukhet Eliyatkin, MD, Study Chair, Affiliation: Bozyaka Training and Research Hospital Pathology Clinic
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
Primary outcome: tumor recurrence by cystoscopic examination, urine and bladder wash cytology
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bozyaka Training and Research Hospital Urology Clinic, Izmir, Turkey
Additional Information
Starting date: February 2009
Last updated: February 16, 2009
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