Intravesical instillation therapy with bacillus Calmette-Guérin (BCG) and sequential BCG and electromotive mitomycin-C (EMDA-MMC) in patients with high-risk non-muscle-invasive bladder carcinoma (FINNBLADDER 10)

Prior treatment

• Prior BCG failure (If patient has previously been successfully treated with BCG, and duration from the last instillation is >12 months, participation may be considered, if bladder preserving is chosen)
• Prior or concurrent immunotherapy

Other illness

• Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
• Cardiac pacemaker
• Urothelial cancer involving the prostatic urethra or upper urinary tract
• Non‐urothelial bladder cancer
• Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)
• Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)
• Known allergy to MMC or BCG

Age

• Age < 18 years

Other

• Ta low grade tumour(s)
• Pregnancy or lactating patient
• Expected survival time less than one year
• Expected poor compliance
• Muscle invasive (pT≥2) tumors

• Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
• 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