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


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Both
Recurrent Superficial Bladder Cancer, Distilled Water

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

tumor recurrence by cystoscopic examination, urine and bladder wash cytology

Outcome Time Frame:

within two years after instillation

Safety Issue:

Yes

Principal Investigator

Zafer Kozacioglu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bozyaka Trainig and Research Hospital Urology Clinic

Authority:

Turkey: Ministry of Health

Study ID:

URO-DW-1971

NCT ID:

NCT00816075

Start Date:

February 2009

Completion Date:

April 2011

Related Keywords:

  • Recurrent Superficial Bladder Cancer
  • Distilled Water
  • distilled water
  • recurrent
  • bladder
  • mitomycin
  • Urinary Bladder Neoplasms

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