Intravesical Adjuvant Electromotive Mitomycin-C

Inclusion criteria

• histologically proven primary stage pTa-pT1 urothelial bladder cancer,
• adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 × 10⁶ cells per L; platelet count ≥120 × 10⁹/L),
• normal renal function (ie, serum creatinine ≤123·76 μmol/L),
• normal liver function (ie, serum glutamic-oxaloacetic aminotransferase ≤42 U/L, serum glutamic-pyruvic aminotransferase ≤48 U/L, and total bilirubin ≤22 μmol/L),
• Eastern Cooperative Oncology Group performance status between 0 and 2.

Exclusion criteria

• non-urothelial carcinomas of the bladder;
• previous or concomitant grade G3 urothelial and/or carcinoma in situ of the bladder;
• urothelial carcinoma of the upper urinary tract and urethra, or both;
• previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs;
• known allergy to mitomycin;
• bladder capacity less than 200 mL;
• untreated urinary-tract
• infection; severe systemic infection (ie, sepsis);
• treatment with immunosuppressive drugs;
• urethral strictures that would prevent endoscopic procedures and catheterisation;
• previous radiotherapy to the pelvis;
• other concurrent chemo therapy, radio therapy, and treatment with biological response modifiers;
• other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer);
• pregnancy;
• any factors that would preclude study participation.