Early vs Delayed Intravesical Blad-Care During BCG Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™): Intravesical instillation of a sterile solution containing sodium hyaluronate and chondroitin sulfate designed to restore the urothelial glycosaminoglycan (GAG) layer.

Study 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

Primary outcome measure(s)

• Change from baseline in the combined Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI) score — 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).
  The ICSI and ICPI are validated scales to assess bladder symptoms and related problems. The combined score ranges from 0 to 31, where higher scores indicate worse symptoms and greater impact on quality of life.

Trial sites (1)

Other trials for the same condition