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

NCT00816075 | Unknown Phase 2

• 1 other identifier: URO-DW-1971
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Superficial Bladder Cancer; Distilled Water

Keywords

distilled water; recurrent; bladder; mitomycin

Outcome Measures

Primary Outcomes (1)

• tumor recurrence by cystoscopic examination, urine and bladder wash cytology

  within two years after instillation

Study Arms (1)

1, Distilled water

EXPERIMENTAL

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

Interventions

distilled water DRUG

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

1, Distilled water

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• carcinoma in situ
• any form of intracavitary maintenance therapy
• any form of bladder cancer other than transitional cell type

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Bozyaka Training and Research Hospital Urology Clinic

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zafer Kozacioglu, MD

  Bozyaka Trainig and Research Hospital Urology Clinic

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Ali R Ayder, MD

  Bozyaka Training and Research Hospital Urology Clinic

  STUDY DIRECTOR

• Nukhet Eliyatkin, MD

  Bozyaka Training and Research Hospital Pathology Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: December 31, 2008
• Study Start: February 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 17, 2009

Record last verified: 2009-02

Locations

TU (1)