This study seeks to optimize the management of TVNIM (reduction of the risk of reccurence of the disease) by comparing in terms of efficacy and tolerance the immediate preoperative administration of mitomycin C (IPOI) to an early postoperative administration (IPOP). It's a national, multicenter, prospective, randomized, comparative study.
Methods. We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Bicêtre Hospital
Le Kremlin-Bicêtre, France
Poitiers University Hospital
Poitiers, France
Rouen University Hospital
Rouen, France
Time to disease recurrence
Time to disease recurrence is defined as the time between resection and the first cystoscopy that detects a recurrence
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.