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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00816075

Enrollment

Registered

2008-12-31

Start date

2009-02-28

Completion date

2011-04-30

Last updated

2009-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distilled Water, Recurrent Superficial Bladder Cancer

Keywords

distilled water, recurrent, bladder, mitomycin

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.

Interventions

DRUGdistilled water

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026