The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.
Recruitment rate
Proportion of patients who consent to participate in the study after being invited to do so
Time frame: 30 days
Randomization rate
Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Time frame: 30 days
Retention rate
Proportion of randomized patients who complete follow-up
Time frame: 2 years
Adverse events (any)
Cumulative incidence of adverse events
Time frame: 30 days
Adverse events (severe)
Cumulative incidence of grade 3-5 adverse events
Time frame: 30 days
Intravesical recurrence
Cumulative incidence of urothelial carcinoma of the bladder
Time frame: 2 years
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