Bladder Cancer Clinical Trial
Official title:
Intravesical Mitomycin-C With Bladder Wall Hyperthermia in Intermediate and High Risk Non-muscle Invasive Bladder Cancer
To investigate effect of intravesical mitomycin-C(MMC) applied with bladder wall thermotherapy system on reccurrence and progression status of intermediate and high risk non muscle invasive bladder cancer
Before the application of TCT, complete transurethral bladder tumour resection (TURBT) was
performed. RE-TURBT was conducted within 4 weeks for patients with initial T1 pathology. The
first TCT instillation was applied at 1mo following the TURBT or the RE-TURBT.
Thermochemotherapy application and treatment schedule:
The bladder wall TCT (BWT) system (Elmedical Ltd, Hod-Hasharon, Israel) was used as a
conductive heating modality. MMC (40 mg; MMC Kyowa Hakko Kogyo Co., Ltd., Tokyo, Japan) was
mixed with 50 mL of 0.9% saline solution and applied using a disposable silicone 20Fr 3-way
TCT catheter (UniThermia catheter; Elmedical Ltd). In each session, the bladder was irrigated
with MMC solution at 42°C-45°C for 45 min via the BWT system. The treatment schedule
consisted of an initial 6-week instillation, followed by control cystoscopy and urine
cytology in the 3rd month and monthly instillations up to 1 yr. Urine cytology and cystoscopy
were performed every three months. The samples were collected from the suspected areas during
cystoscopy. At the end of the first year, control cystoscopy with random bladder biopsies was
conducted. During the second year, routine controls were conducted every three months.
Subsequently, follow-ups were performed every six months. In case of development of any
complication in a patient, TCT was discontinued. Before each instillation of TCT, clear urine
cultures were obtained from all patients. No prophylactic anticholinergic was administered
prior to intravesical TCT. If TUR BT pathology was Ta or T1 during the follow-up, it was
accepted as a recurrence. If it was CIS or T2, it was accepted as a progression. All adverse
events observed during the study were recorded according to the Common Terminology Criteria
for Adverse Events (CTCAE) Version 4.0 [9. All study protocols were approved by the local
ethical committee at our institution. An informed consent was obtained from all patients.
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