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

Primary Purpose

Recurrent Superficial Bladder Cancer, Distilled Water

Status

Unknown status

Phase

Phase 2

Locations

Turkey

Study Type

Interventional

Intervention

distilled water

About this trial

This is an interventional prevention trial for Recurrent Superficial Bladder Cancer focused on measuring distilled water, recurrent, bladder, mitomycin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bozyaka Training and Research Hospital Urology Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1, Distilled water

Arm Description

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

Outcomes

Primary Outcome Measures

tumor recurrence by cystoscopic examination, urine and bladder wash cytology

Secondary Outcome Measures

Full Information

NCT ID

NCT00816075

First Posted

December 30, 2008

Last Updated

February 16, 2009

Sponsor

Bozyaka Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00816075

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

January 2011 (Anticipated)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bozyaka Training and Research Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Superficial Bladder Cancer, Distilled Water

Keywords

distilled water, recurrent, bladder, mitomycin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1, Distilled water

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

distilled water

Intervention Description

we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours

Primary Outcome Measure Information:

Title

tumor recurrence by cystoscopic examination, urine and bladder wash cytology

Time Frame

within two years after instillation

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: