300
Participants
Start Date
October 26, 2018
Primary Completion Date
November 1, 2025
Study Completion Date
November 1, 2025
BCG instillation therapy
Induction period of six weekly instillations of BCG followed by maintenance period of ten monthly instillations of BCG
Sequential BCG and EMDA mitomycin C
"Induction period includes nine weekly instillations of sequential BCG and EMDA-MMC instillations applied as three cycles of BCG, BCG and EMDA-MMC. Induction period is followed by maintenance period of nine monthly instillations of sequential EMDA-MMC and BCG applied with three cycles of EMDA-MMC, EMDA-MMC and BCG.~BCG instillation is performed as a standard instillation.~Mitomycin C is administered with electromotive drug administration (EMDA) device (Instillation: 40 mg mitomycin C with 960 mg of excipient sodium chloride dissolved in 100 ml sterile water, EMDA settings: current rise rate 30-50 microamperes per second, max 25 milliamperes, treatment duration 30 min)"
RECRUITING
Päijät-Häme Central hospital, Lahti
RECRUITING
Turku University Hospital, Turku
RECRUITING
Tampere University Hospital, Tampere
RECRUITING
Jyväskylä Central Hospital, Jyväskylä
RECRUITING
Mikkeli Central Hospital, Mikkeli
RECRUITING
Seinäjoki Central Hospital, Seinäjoki
RECRUITING
HYKS Peijas Hospital, Helsinki
Finnbladder
OTHER
Turku University Hospital
OTHER_GOV