Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer

January 10, 2023 updated by: Bellos Themistoklis, National and Kapodistrian University of Athens
The study compares the complications caused after the BCG intravesical instillation in patients treated for non invasive bladder cancer.The patients are divided into two groups one receiving IVI (intravesical Instillations) with the use of latex catheter while in the other silicone catheter is used.The two groups are compared in terms of fever, hematuria, LUTS and other complications following IVI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bladder cancer is the 9th most common diagnosed cancer according to 2021 statistics (4). It can be divided into muscle invasive (MIBC) and non muscle invasive bladder cancer (NMIBC) , based on the biopsy result after transurethral resection of the bladder tumor.In this research we will abide ourselves to the non muscle invasive bladder cancer.After the transurethral resection of bladder cancer, further management of this disease includes the intravesical instillation of chemotherapy or immunotherapeutic drugs.

The most commonly used drugs in our clinic is epirubicin and Bacillus Calmette Guerrin (BCG) for intravesical instillations.This research will focus on the use of intravesical instillations of BCG .Intravesical instillations of BCG are performed in patients with pTa/High Grade (HG), pT1/Low Grade(LG), pT1/HG and Carcinoma in Situ(CIS) tumors , while epirubicin is used in tumors pTa/LG.

The most common complications after intravesical instillation of BCG are either systemic (mycotic aneyrysms , tuberculosis, hepatitis, arthritis , spondylitis or ev enencephalitis) or are related to the urogenital system (cystitis, prostatitis which can be either tuberculous or bacterial, balanitis or tuberculous epididymitis) (3). The most common complications of the urinary system after the intravesical BCG instillation can appear as a combination of the lower urinary tract symptoms (LUTS) , macroscopic hematuria and fever (4).

There are researches that prove the superiority of silicon catheters for long term catheterization in terms of reduced urethral inflammation and consequently reduced LUTS (1,2). However, there is also an article that claims that latex urinary catheters that are coated with noble metals cause minimal LUTS compared with silicone catheters when used for short term catheterization (3). Nevertheless, there is not a comparative antegrade study for the use of different type of catheters for the intravesical instillation of BCG that proves the superiority of one catheter type over the other.

Purpose of this study The purpose of this study is the comparison of the symptoms arising from the use of two different types of urinary catheters (latex or silicon tiemann) during the intravesical instillation of BCG and the possible display of superiority of one of those catheter types.

Material and Methods This study is an antegrade comparative cohort study. In this are included patients of all age and genders. The patients were diagnosed with non muscle invasive bladder cancer after the transurethral resection of the bladder tumor and are undergoing intravesical BCG instillations after they get their biopsy results.They undergo either 6 weekly intravesical instillations in de novo diagnosed cancer or in 3 weekly instillations during the follow-up based on our clinic's protocol. The intravesical therapy begins 2-4 weeks after the surgery , since the patients has a negative urine culture. Another important condition is that the patient does not have macroscopic hematuria ,does not have fever or does not bleed during the catheter insertion.

The intravesical instillation is performed in the outpatient department of the 2nd University Urology Clinic in Sismanogleio Hospital ,Athens, Greece by three urologist J.M. ,T.B. and S.K.. Those three physicians use aseptic and non traumatic technique during the intravesical instillations (IVIs). For the IVIs either self lubricated silicon tiemann 10 fr urinary catheter or straight tipped latex foley 14 fr urinary catheter was used. The catheterization was done with the use of 2% xylocaine jelly in the urethra.The catheter was advanced slowly while the intravesical instillation was done slowly in a rate so that it was completed in 20-30 s.This technique was used by all the physicians.

The preparation and dilution of the drug used for the IVIs was done by the same trained nurses, under the same conditions for each case and is instilled as soon as it is ready.Before every insillation the physician asks the patient if he has symptoms since the previous instillation such as macroscopic hematuria, fever or LUTS. In case that one of those symptoms exists then the instillation is not performed.In case of hematuria ,instillation is postponed until this symptom disappears.In case of persisting LUTS until the the next instillation the patient receives antibiotic regimen based on urinary culture and continues with the instillation when the culture is negative. In case of fever above 38 celsius the patient undergoes an empiric antibiotic regimen with quinolones. If fever persists over 48 hours then the patient is reffered to an internist with subspecialisation in infectious medicine to exlude the possibility of systemic or urogenital tuberculous complication. The intravesical instillation regimen continues when the patient has no longer fever.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Marathon, Attica, Greece, 19007
        • Themistoklis Bellos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with BCG.

Description

Inclusion Criteria:

  • BCG intravesical instillation for non muscle invasive bladder cancer

Exclusion Criteria:

  • Positive culture
  • Preexisting LUTS
  • Muscle invasive bladder cancer

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of self lubricated silicon tiemann 10 fr urinary catheter.
Drug: BCG
Intravesical Instillation
Other Names:
  • Intravesical Instillation
Group 2
Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of straight tipped latex foley 14 fr urinary catheter
Drug: BCG
Intravesical Instillation
Other Names:
  • Intravesical Instillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 1.5 year
Complications in both groups- hematuria, fever, LUTS , systemic symptoms
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2020

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15306/26-7-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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