Status:
COMPLETED
Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Poisoning by BCG Vaccine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial cell carcinoma.
Detailed Description
Bacillus Calmette-Guérin (BCG) is considered the most effective treatment to increase disease-free interval and reduce progression of non-muscle invasive bladder cancer (NMIBC) \[1\]. Although conside...
Eligibility Criteria
Inclusion
- Histologically proven non-muscle invasive bladder cancer;
- Indication to intravesical instillation of BCG according to EAU guidelines;
- Age \> 18 years;
- Willingness, to participate to the study;
- Written informed consent.
Exclusion
- Previous or ongoing BCG or different intravesical instillations;
- Urinary tract infections (UTI) or other known pathologies of the lower urinary tract;
- Indication for a radical cystectomy;
- Severe systemic disorders, including neurological pathologies, kidney, liver or heart failure;
- Contraindications to BCG use.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02207608
Start Date
September 1 2011
End Date
August 1 2012
Last Update
May 28 2015
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