Clinical trial · Interventional
Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects
Pilot Study of Influence of Hyaluronic Acid (HA) on Bacillus Calmette-Guérin (BCG) Local Side Effects
NCT02207608CI-TRIAL-00018057completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Poisoning by BCG Vaccine | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG (Immucist®) | Drug | — | UNRESOLVED |
| Hyaluronic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BCG alone (Immucist®)
- description
- Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
- interventionNames
- Drug: BCG (Immucist®)
- type
- EXPERIMENTAL
- label
- Hyaluronic acid
- description
- Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
- interventionNames
- Drug: Hyaluronic Acid
- Drug: BCG (Immucist®)
Primary outcomes (1)
- measure
- Visual Analogue Scale for Pain
- timeFrame
- Before and after six weeks of treatment (end of induction course)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDTopazio L, Miano R, Maurelli V, Gaziev G, Gacci M, Iacovelli V, Finazzi-Agro E. Could hyaluronic acid (HA) reduce Bacillus Calmette-Guerin (BCG) local side effects? Results of a pilot study. BMC Urol. 2014 Aug 13;14:64. doi: 10.1186/1471-2490-14-64. PMID 25123116