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

NCT ID: NCT00816075

Last Updated: 2009-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-04-30

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.

Conditions

Recurrent Superficial Bladder Cancer; Distilled Water

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

distilled water

Intervention Type: DRUG

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

Interventions

distilled water

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

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bozyaka Training and Research Hospital Urology Clinic

Principal Investigators

Zafer Kozacioglu, MD

Role: PRINCIPAL_INVESTIGATOR

Bozyaka Trainig and Research Hospital Urology Clinic

Murat Arslan, MD

Role: STUDY_CHAIR

Bozyaka Training and Research Hospital Urology Clinic

Tansu Degirmenci, MD

Role: STUDY_CHAIR

Bozyaka Training and Research Hospital Urology Clinic

Fatih Duz, MD

Role: STUDY_CHAIR

Bozyaka Training and Research Hospital Urology Clinic

Ali R Ayder, MD

Role: STUDY_DIRECTOR

Bozyaka Training and Research Hospital Urology Clinic

Nukhet Eliyatkin, MD

Role: STUDY_CHAIR

Bozyaka Training and Research Hospital Pathology Clinic

Locations

Bozyaka Training and Research Hospital Urology Clinic

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

URO-DW-1971

Identifier Type: -

Identifier Source: org_study_id