Superficial Bladder Cancer Clinical Trial
Official title:
Single Preoperative Intravesical Instillation of Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer: a Prospective Randomized Trial.
Early single instillation of chemotherapy after TUR is recommended in the European
Association of Urology Guidelines. Nevertheless, the procedure is suboptimal for patients
with multiple tumors, sometimes is not tolerated and it can results in severe complications.
In both laboratory and clinical studies, intravesical electromotive drug administration
(EMDA) increases mitomycin-C (MMC) bladder uptake, resulting in an improved clinical
efficacy in non-muscle invasive bladder cancer (NMIBC). The investigators will compare the
effects of one immediate pre-TUR intravesical EMDA/MMC instillation with one immediate
post-TUR intravesical passive diffusion MMC (PD/MMC) instillation and TUR alone in patients
with NMIBC.
All eligible patients with primary NMIBC will be randomized into 3 groups who will undergo
transurethral resection alone (TUR/alone); TUR plus single immediate postoperative
instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes; or
single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with
20 mA electric current for 30 minutes. Patients with intermediate and high risk NMIBC will
undergo adjuvant intravesical therapy. The primary end points will be the recurrence rate
and disease-free interval. All clinical analyses will be performed on an intent to treat
basis.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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