Suspended

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

What is being tested

distilled water

Drug

Who is being recruted

Urogenital Diseases+16

+ Non-Muscle Invasive Bladder Neoplasms

+ Urinary Bladder Diseases

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 2 & 3

Interventional

Study Start: February 2009

See protocol details

Summary

Principal SponsorBozyaka Training and Research Hospital

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2009

Actual date on which the first participant was enrolled.

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.

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

NCT00816075

Principal SponsorBozyaka Training and Research Hospital

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesNon-Muscle Invasive Bladder NeoplasmsUrinary Bladder DiseasesUrinary Bladder NeoplasmsCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPathologic ProcessesRecurrencePathological Conditions, Signs and SymptomsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsDisease AttributesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

3 inclusion criteria required to participate

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.

3 exclusion criteria prevent from participating

carcinoma in situ

any form of intracavitary maintenance therapy

any form of bladder cancer other than transitional cell type

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Bozyaka Training and Research Hospital Urology Clinic

Izmir, Turkey (Türkiye)Open Bozyaka Training and Research Hospital Urology Clinic in Google Maps

SuspendedOne Study Center