Phase 2
Completed N=30
Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects
Poisoning by BCG Vaccine
Source: ClinicalTrials.gov NCT02207608 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Visual Analogue Scale for Pain — 4.5; 4.9; 5.8; 4.2 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale for Pain |
4.5; 4.9; 5.8; 4.2 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02207608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.