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
BLAD-HYA Group
56 participants
Nov 3, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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
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Interventions
Intravesical instillation of a sterile solution containing sodium hyaluronate and chondroitin sulfate designed to restore the urothelial glycosaminoglycan (GAG) layer.
Locations(1)
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NCT07495072