Intravesical Instillation Therapy With Bacillus Calmette-Guérin (BCG) and Sequential BCG and Electromotive Mitomycin-C (EMDA-MCC) in Patients With High-risk Non-muscle-invasive Bladder Carcinoma
Disease recurrence and progression is a major issue in high risk non-muscle-invasive bladder cancer (NMIBC). The current study compares two adjuvant instillation therapies in the treatment of high risk NMIBC. After resection of the tumour(s), patients will receive either traditional regimen of Bacillus Calmette-Guérin (BCG) instillations or combination treatment consisting of sequential BCG-instillations and mitomycin C instillations administered with electromotive drug administration (EMDA) device.
• Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
• Carcinoma in situ with or without a papillary tumour(s)
• Ta tumour(s) of high-grade
• Any T1 tumour(s)
• Written informed consent is required from every eligible patient
• Second resection performed in case of T1 tumour
• Adequate physical and mental condition to participate in the study (as judged by treating physician