Clinical trial · Interventional
Early vs Delayed Intravesical Blad-Care During BCG Therapy
Optimal Timing of Intravesical GAG Restoration Therapy for BCG-Induced Bladder Toxicity in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Randomized Study
- 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)
Intravesical Bacillus Calmette-Guérin (BCG) therapy is the standard adjuvant treatment for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC). However, BCG therapy frequently induces local bladder irritation symptoms including urinary frequency, urgency, dysuria, hematuria, and suprapubic pain, which may reduce quality of life and lead to treatment interruption. Blad-Care™ is an intravesical therapy containing hyaluronic acid and chondroitin sulfate, key components of the urothelial glycosaminoglycan (GAG) layer. Restoration of the GAG layer may protect the bladder mucosa and reduce inflammation-induced bladder irritation symptoms. This prospective randomized study aims to determine whether early administration of intravesical Blad-Care during BCG induction improves BCG-induced bladder toxicity compared with delayed administration after completion of BCG induction therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCG-Induced Cystitis | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (Early Blad-Care Administration)
- description
- Patients receive intravesical BCG once weekly for six weeks. Beginning with the fourth BCG instillation, intravesical Blad-Care is administered immediately after BCG instillation for three consecutive weeks (weeks 4-6).
- interventionNames
- Drug: Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)
- type
- ACTIVE_COMPARATOR
- label
- Group B (Delayed Blad-Care Administration)
- description
- Patients receive intravesical BCG once weekly for six weeks. Blad-Care is administered after completion of the BCG induction course and repeated weekly for three consecutive weeks.
- interventionNames
- Drug: Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged ≥19 years * Histologically confirmed non-muscle-invasive bladder cancer * Candidates for intravesical BCG therapy * Negative urine culture prior to BCG therapy * Ability to provide written informed consent Exclusion Criteria: * Hypersensitivity to components of Blad-Care * Contraindication to BCG therapy * Neurogenic bladder or significant urinary tract abnormalities * Severe renal dysfunction * Any condition considered unsuitable for study participation by the investigator
References
Publications (0)
Data not yet available