Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rome Tor Vergata
• Treatments: BCG Vaccine; Hyaluronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.