Contraindications

The Synergo system should not be used in patients with:

• Tumor stage T>T1 (Muscle invasive);

• UCC outside the urinary bladder (urethra, ureters, kidneys, distant organs);

• Any concurrent tumor that requires active or concurrent treatment;

• Non transitional cell carcinoma of the bladder;

• Intramural tumors (eg, in ostium);

• Urinary bladder diverticulum/diverticula with a cumulative diameter larger than 1cm;

• Abnormal bladder contour;

• Bladder volume < 150cc (mL);

• Contracted bladder;

• Significant urinary incontinence (spontaneous, requiring use of > 1 pad/day (PPD);

• Gross hematuria;

• Pregnancy, nursing mothers,

• UTI (urinary tract infection),

• Inability to pass an 18-F catheter (until stricture/stenosis treated);

• Urethral stricture;

• Fistula;

• Significant residual bladder volume;

• Partial cystectomy,

• Previous pelvic irradiation therapy;

• Known allergy to chemotherapy;

• Inflammation of the bladder;

• Low blood count;

• Severe liver function disorder;

• History of pelvic irradiation;

• Artificial penile implant;

• Patients with any type of electronic devices implanted in abdominal cavity;

• Cardiac disease unless authorized by cardiologist.