Impact of Reducing Irritative Symptoms in Non-Muscle Invasive Bladder Cancer During BCG Instillation: A Pilot Study

Abstract
INTRODUCTION: We evaluated use of anticholinergics, mirabegron, and combination of anticholinergics with mirabegron during Bacillus Calmette-Guérin (BCG) instillation for reducing irritative symptoms in patients with non-muscle invasive bladder cancer (NMIBC). METHODS: Prospectively recorded data of NMIBC patients receiving BCG were retrospectively evaluated between August 2015 and April 2019. Patients with low-grade T1 solitary papillary lesions <4 cm were included in the study. Validated questionnaires (OAB-V8) for irritative symptoms adapted to Turkish language, and QoL index forms were filled out by the study participants. OAB-V8 scores of ≥8 were considered as an indication to start medical treatment for irritative symptoms. Groups were formed according to daily used anticholinergic drugs and combinations as follows: Group 1, tolterodine; Group 2, solifenacin 5mg; Group 3, mirabegron, and Group 4, mirabegron with solifenacin 5 mg. RESULTS: Mean follow- up period was 20.4±6.8 months. There were 132 patients [110 men (83%) and 22 (17%) women] with irritative symptoms and NMIBC. Mean age of the study population was 59.7±12.4 years. The OAB-V8 scores and QoL indexes significantly improved with all drugs. However, in subgroup analyses, Group 4 provided the most dramatic improvement in OAB-V8 and QoL index scores (P=0.02 for both). The longest in time to micturition was recorded in Group 4 (P=0.04). Tumour recurrence was similar for groups 12 months after BCG instillation (P=0.9), however the least recurrence was observed in Group 4. DISCUSSION AND CONCLUSION: Combination of solifecacin and mirabegron can reduce irritative symptoms, improve QoL, and prolong time to micturition, during BCG instillation in selected NMIBC patients. This combination may also decrease recurrence rates in this patient population.