Optimal Timing of Intravesical GAG Restoration Therapy for BCG-Induced Bladder Toxicity in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Randomized Study

What this Trial Is About

Researchers are evaluating the timing of intravesical Blad-Care therapy alongside Bacillus Calmette-Guérin (BCG) treatment in patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC). BCG therapy is standard for reducing tumor recurrence but often causes bladder irritation symptoms like urinary frequency, urgency, dysuria, hematuria, and suprapubic pain, which can affect quality of life and treatment adherence. Blad-Care contains hyaluronic acid and chondroitin sulfate, which may help restore the protective bladder lining and reduce these symptoms. The study compares early versus delayed administration of Blad-Care during BCG induction therapy. All participants receive intravesical BCG once weekly for six weeks. In the early Blad-Care group, the therapy starts immediately after the fourth BCG instillation and continues weekly for three weeks. In the delayed group, Blad-Care is given after completing the full six-week BCG treatment, once a week for three weeks. This approach aims to identify the best timing to reduce BCG-induced bladder toxicity. Participants undergo symptom assessments using the combined Interstitial Cystitis Symptom Index and Problem Index at multiple points: before treatment, after the third and sixth BCG treatments, and two months post-therapy. Additional measures include pain scores, incidence of hematuria, adverse events, treatment completion rates, use of other urinary symptom medications, and cancer recurrence rates. The study follows participants for approximately 15 months to evaluate these outcomes and monitor treatment safety and effectiveness.

Early vs Delayed Intravesical Blad-Care During BCG Therapy