Early vs Delayed Intravesical Blad-Care During BCG Therapy

Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 70-75% of newly diagnosed bladder cancers. Intravesical BCG therapy after transurethral resection of bladder tumor (TURBT) significantly reduces tumor recurrence and progression in intermediate- and high-risk NMIBC.

Despite its proven oncologic benefit, BCG therapy commonly induces local bladder inflammation resulting in urinary frequency, urgency, dysuria, hematuria, and suprapubic pain. These adverse effects may impair patient quality of life and reduce adherence to BCG therapy.

Experimental evidence suggests that BCG-induced cystitis is associated with damage to the urothelial glycosaminoglycan (GAG) layer, which normally protects the bladder mucosa from urinary irritants. Disruption of this protective barrier may contribute to bladder irritation symptoms.

Blad-Care™ contains hyaluronic acid and chondroitin sulfate, two major components of the GAG layer, and may restore the urothelial protective barrier and reduce bladder inflammation.

Previous studies have suggested that GAG restoration therapy may improve symptoms in patients with chemical cystitis; however, evidence regarding its role during BCG therapy remains limited, and the optimal timing of administration has not been established.

This multicenter prospective randomized study will compare early versus delayed intravesical administration of Blad-Care during BCG induction in patients with NMIBC to determine the optimal timing for reducing BCG-induced bladder toxicity.

• Change from Baseline in Visual Analogue Scale (VAS) Score for Suprapubic Pain [Срок оценки: Baseline (Week 0), after 3rd BCG instillation (Week 3), after 6th BCG instillation (Week 6), and 2 months after completion of BCG therapy (Week 14).]
• Incidence and Severity of Hematuria [Срок оценки: From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).]
• BCG Treatment Completion Rate [Срок оценки: From the date of the first BCG instillation (Week 1) through the date of the sixth BCG instillation (Week 6).]
• Incidence of Initiation of Additional Medications for Lower Urinary Tract Symptoms (LUTS) [Срок оценки: From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).]
• Recurrence-Free Rate of Non-Muscle Invasive Bladder Cancer (NMIBC) [Срок оценки: From the date of randomization until the study completion (June 2027, approximately 15 months).]