About this trial
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 criteria
Qualifiers
Adults aged ≥19 years
Histologically confirmed non-muscle-invasive bladder cancer
Candidates for intravesical BCG therapy
Negative urine culture prior to BCG therapy
Disqualifiers
Hypersensitivity to components of Blad-Care
Contraindication to BCG therapy
Neurogenic bladder or significant urinary tract abnormalities
Severe renal dysfunction
Trial design
Treatments tested in this trial
- Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)
Treatment groups
Sponsors and collaborators
BLAD-HYA Group
Lead sponsor
Kyung Hee University Hospital
Sponsor institution
Eulji University
Collaborator