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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Bozyaka Training and Research Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT00816075
First received: December 30, 2008
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Recurrent Superficial Bladder Cancer
Distilled Water
Drug: distilled water
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bozyaka Training and Research Hospital:

Primary Outcome Measures:
  • tumor recurrence by cystoscopic examination, urine and bladder wash cytology [ Time Frame: within two years after instillation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: distilled water
we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816075

Locations
Turkey
Bozyaka Training and Research Hospital Urology Clinic
Izmir, Turkey
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
Principal Investigator: Zafer Kozacioglu, MD Bozyaka Trainig and Research Hospital Urology Clinic
Study Chair: Murat Arslan, MD Bozyaka Training and Research Hospital Urology Clinic
Study Chair: Tansu Degirmenci, MD Bozyaka Training and Research Hospital Urology Clinic
Study Chair: Fatih Duz, MD Bozyaka Training and Research Hospital Urology Clinic
Study Director: Ali R Ayder, MD Bozyaka Training and Research Hospital Urology Clinic
Study Chair: Nukhet Eliyatkin, MD Bozyaka Training and Research Hospital Pathology Clinic
  More Information

No publications provided

Responsible Party: Zafer Kozacioglu, Bozyaka Training and Research Hospital Urology Clinic
ClinicalTrials.gov Identifier: NCT00816075     History of Changes
Other Study ID Numbers: URO-DW-1971
Study First Received: December 30, 2008
Last Updated: February 16, 2009
Health Authority: Turkey: Ministry of Health

Keywords provided by Bozyaka Training and Research Hospital:
distilled water
recurrent
bladder
mitomycin

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on April 15, 2014