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

Distilled Water Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00816075
• Other study ID #: URO-DW-1971
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: December 30, 2008
• Last updated: February 16, 2009
• Start date: February 2009
• Est. completion date: April 2011

Study information

• Verified date: February 2009
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Distilled Water
• Recurrent Superficial Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Turkey	Bozyaka Training and Research Hospital Urology Clinic	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor recurrence by cystoscopic examination, urine and bladder wash cytology		within two years after instillation	Yes