Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.

Inclusion criteria

• ✓. Patients with current CIS of the bladder, with or without coexisting papillary Ta/T1 NMIBC tumor(s), who experienced an occurrence or recurrence of CIS within 12 months of completion of adequate BCG7 therapy. An adequate BCG regimen shall consist of at least 2 courses of BCG where the first course (induction) must have included at least 5 of 6 weekly treatments and the second course may have included a re-induction (at least 2 of 6 treatments) or maintenance, (at least 2 of 3 treatments) administered on a schedule similar to the SWOG 8507 study regimen.
• ✓. All clinical, intra-operative and pathological items for the AUA risk stratification must be documented. This includes bladder mapping, according to the instructions specified in the protocol. With regard to BCG and/or other NMIBC treatments documentation must include:
• ✓. Date of initial treatment,
• ✓. Date of last treatment,
• ✓. The number of courses administered and the number of treatments administered in each course.
• ✓. Patients with concomitant papillary tumor(s) must have undergone a repeat TUR 2-4 weeks prior to the first study treatment:
• ✓. if the previous TUR was incomplete,
• ✓. if there was no muscle in the specimen after the initial TUR (except in TaLG tumors),