Intravesical Adjuvant Electromotive Mitomycin-C

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

331

Participants

Timeline

Start Date

January 31, 1994

Primary Completion Date

December 31, 2004

Study Completion Date

June 30, 2013

Conditions
Bladder Cancer TNM Staging Primary Tumor (T) TaBladder Cancer TNM Staging Primary Tumor (T) T1Bladder Cancer Transitional Cell Grade
Interventions
PROCEDURE

Trans-urethral resection

Patients underwent urinary cytology of the bladder and upper urinary tract; random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples.

DRUG

intravesical passive diffusion mitomycin

A dose of 40 mg mitomycin dissolved in 50 ml sterile water is infused intravesically through a Foley catheter, retained in the bladder for 60 min with catheter clamping, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations, with the same dose and methods of infusion as initial assigned treatment.

DEVICE

intravesical electromotive mitomycin

A dose of 40 mg mitomycin dissolved in 100 ml water is instilled and retained in the bladder for 30 minutes with 20 mA pulsed electric current, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations with the same dose and methods of infusion as initial assigned treatment. Intravesical electromotive drug administration is given by a battery-powered generator delivering a controlled electric current that passes between the active intravesical electrode (integrated into a specific transurethral catheter) and dispersive ground electrodes (on skin of the lower abdomen). Operators set active electrode polarity and current intensity on the generator.

Trial Locations (1)

00133

Tor Vergata University, Department of experimental Medicine and Surgery/Urology, Rome

All Listed Sponsors
collaborator

University of L'Aquila

OTHER

collaborator

University Of Perugia

OTHER

lead

University of Rome Tor Vergata

OTHER