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

Bozyaka Training and Research Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Recurrent Superficial Bladder Cancer; Distilled Water

Treatments: Drug: distilled water

Study type: Interventional

Funder types: Other

Identifiers

NCT00816075

URO-DW-1971

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 1 patient group

1, Distilled water

Experimental group

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

Treatment:

Drug: distilled water