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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

Page last updated: August 23, 2015

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