A randomized controlled study comparing intravesical Synergo® System adjuvant hyperthermia treatment in
conjunction with Mitomycin C (LHT + MMC) versus BCG intravesical immunotherapy (BCG) adjuvant treatment
in patients with Superficial Transitional Cell Carcinoma of the Bladder (STCCB)
Medical Enterprises ongoing clinical study started in 2002. It is a randomized,
multi-center study. Urology departments in Hospitals from Italy, France, The
Netherlands, Belgium and Israel are participating in the study.
The clinical study Chief investigator is:
Prof J.A Witjes, Department of Urology, Radboud University Hospital,
Nijmegen, The Netherlands.
Study Participants:
Patients suffering from Superficial Transitional Cell Carcinoma of the Urinary Bladder (Ta, T1 or CIS) after tumor removal by Surgery (TUR).
Intermediate to high risk for recurrence or progression.
No previous intra vesicle instillations of MMC in last 12 months, or BCG in last 24 months