Clinical Trial

Early vs Delayed Intravesical Blad-Care During BCG Therapy

Study acronym: PRO-GAG
Recruiting
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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.
Trial Details
NCT Number NCT07495072
Lead Sponsor BLAD-HYA Group
Collaborators: Eulji University
Conditions Urinary Bladder Neoplasms, BCG-Induced Cystitis
Enrollment 56 participants
Start Date 2025-11-03
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-27