Clinical trial NCT00816075: Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Recurrent Superficial Bladder Cancer
Distilled Water
Keywords: distilled water
recurrent
bladder
mitomycin
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2008-12-31
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: tumor recurrence by cystoscopic examination, urine and bladder wash cytology
timeFrame: within two years after instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Bozyaka Training and Research Hospital Urology Clinic
Study officials:
affiliation: Bozyaka Trainig and Research Hospital Urology Clinic
name: Zafer Kozacioglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bozyaka Training and Research Hospital Urology Clinic
name: Murat Arslan, MD
role: STUDY_CHAIR
affiliation: Bozyaka Training and Research Hospital Urology Clinic
name: Tansu Degirmenci, MD
role: STUDY_CHAIR
affiliation: Bozyaka Training and Research Hospital Urology Clinic
name: Fatih Duz, MD
role: STUDY_CHAIR
affiliation: Bozyaka Training and Research Hospital Urology Clinic
name: Ali R Ayder, MD
role: STUDY_DIRECTOR
affiliation: Bozyaka Training and Research Hospital Pathology Clinic
name: Nukhet Eliyatkin, MD
role: STUDY_CHAIR
References: