Background: Non-muscle invasive bladder cancer (NMIBC) constitutes a significant proportion of urothelial malignancies. The optimal choice between intravesical chemotherapy and immunotherapy remains debatable, particularly regarding efficacy and recurrence rates.

Objective: To prospectively compare the efficacy of intravesical chemotherapy and immunotherapy in NMIBC patients in terms of recurrence, progression, and therapy-related complications.

Methods: A randomized controlled trial was conducted on 56 NMIBC patients from March 2023 to March 2025 at GSVM Medical College, Kanpur. Patients were assigned to either intravesical chemotherapy (Arm A: Gemcitabine/Mitomycin C) or immunotherapy (Arm B: Bacillus Calmette-Guérin – BCG). They were followed for 9 months with regular cystoscopic evaluation. Clinical outcomes including recurrence and complications were analyzed.

Results: Recurrence was significantly lower in the immunotherapy group compared to chemotherapy (p < 0.001). Histological subtype and tumor stage correlated with recurrence. Most recurrences occurred after 9 months. The immunotherapy group also showed a higher rate of bladder irritation and LUTS.

Conclusion: Intravesical BCG immunotherapy is superior in reducing recurrence compared to chemotherapy in NMIBC, although it is associated with increased local side effects. Larger, multicenter studies with extended follow-up are warranted.

Keywords: Non-muscle invasive bladder cancer, BCG, Gemcitabine, Mitomycin C, Intravesical therapy, Recurrence