Objective: A single immediate instillation of Mitomycin C is recommended after a complete transurethral resection of the bladder (TURB) in low- and intermediate- risk patients with NMBIC. Actually, post-TURB instillation is not universally used due to logistical difficulties and surgical contraindications. Our aim was to compare patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of Mitomycin C.
Methods: We performed a multicentre randomized trial between Nov 1, 2013 and Nov 1,2015 (Accord CPP Ouest III 2012-004341-32) providing for inclusion 54 patients with: Unifocal or multifocal, primary or recurrence, endoscopic papillary bladder tumors with a negative urinary cytology. Cystoscopy were 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 who didn’t benefit from the instillation and tolerance 1 month after TURB using BCI-Fr score.
Results: Among 35 eligible participants, 20 were randomly assigned in the pre-TURB instillation group and 15 in the post-TURB instillation group. Follow-Up was comparable: 12,3 ± 1,6 months in the SI group and 10,2 ± 4,5 months in the pre-TURB instillation group. In the post-TURB instillation group, 2 patients didn’t have any instillation. We did not identify significant differences in disease-free interval (Table 1). Tolerance at 1 month after TURB was similar in both groups (Table2).
Conclusion: Tolerance and efficacy were comparable. As expected, feasibility (logisitic, contraindications) was better in the pre-TURB instillation group. These results suggest that single immediate pre-TURB instillation could be an option, a phase III randomized trial is needed to confirm it.
Table1: Recurrence rate: follow-up at 3, 6 and 12 months.
Table 2: Tolerance at 1 month.
