Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection

February 16, 2009 updated by: Bozyaka Training and Research Hospital

The Efficacy of Distilled Water vs Mitomycin C as a Single Dose Immediate Instillation After Transurethral Resection of Intermediate Risk, Recurrent Superficial Bladder Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey
        • Bozyaka Training and Research Hospital Urology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1, Distilled water
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
Drug: distilled water
we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tumor recurrence by cystoscopic examination, urine and bladder wash cytology
Time Frame: within two years after instillation
within two years after instillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozyaka Training and Research Hospital

Investigators

  • Principal Investigator: Zafer Kozacioglu, MD, Bozyaka Trainig and Research Hospital Urology Clinic
  • Study Chair: Murat Arslan, MD, Bozyaka Training and Research Hospital Urology Clinic
  • Study Chair: Tansu Degirmenci, MD, Bozyaka Training and Research Hospital Urology Clinic
  • Study Chair: Fatih Duz, MD, Bozyaka Training and Research Hospital Urology Clinic
  • Study Director: Ali R Ayder, MD, Bozyaka Training and Research Hospital Urology Clinic
  • Study Chair: Nukhet Eliyatkin, MD, Bozyaka Training and Research Hospital Pathology Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

April 1, 2011

Study Registration Dates

First Submitted

December 30, 2008

First Submitted That Met QC Criteria

December 30, 2008

First Posted (ESTIMATE)

December 31, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2009

Last Update Submitted That Met QC Criteria

February 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO-DW-1971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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