200
Participants
Start Date
December 20, 2024
Primary Completion Date
December 31, 2026
Study Completion Date
June 30, 2027
Hydeal Cyst®
"BCG or MMC will be started within 1-2 weeks from randomization (within 4-6 weeks after TURB).~BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.~IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment.~48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation.~BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation."
RECRUITING
Humanitas Gavezzeni-Bergamo, Bergamo
RECRUITING
Istituto Oncologico Veneto IRCCS, Padua
RECRUITING
Policlinico Paolo Giaccone, Palermo
NOT_YET_RECRUITING
Ospedale Sant'Orsola - Malpighi, Bologna
RECRUITING
Policlinico Ospedali Riuniti - Foggia, Foggia
RECRUITING
Azienda Ospedale Università Padova, Padua
RECRUITING
Ospedali Riuniti Padova Sud, Padua
RECRUITING
Ospedale Santa Maria della Misericordia - ASU FC, Udine
RECRUITING
Azienda Ospedaliera Universitaria Integrata - Verona, Verona
Collaborators (1)
Fidia Farmaceutici s.p.a.
INDUSTRY
Istituto Oncologico Veneto IRCCS
OTHER