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Details for trial 4B-01-2
Description:
A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients.
Status:
Open
Randomized?
Yes
Researchers
Principal Investigator
Title
Eila Skinner
M.D.
Data Management
Name
Title
You may participate in this study if:
Requirement
1
Diagnosed with primary bladder cancer (any histology) who are undergoing radical cystectomy (cystoprostatectomy in men and anterior exenteration in women).
2
Felt by the treating MD to be a candidate for an orthotopic neobladder urinary diversion.
3
May have received previous RT or intravesical or systemic chemotherapy. If the treatment was for another malignancy, then at least 5 years must have elapsed since the last evidence of disease. Patients with documented metastatic disease are not excluded as long as they are felt to be candidates for a continent neobladder urinary diversion.
4
Signed informed consent.
You may not participate in this study if:
1
Undergoing radical cystectomy for any malignancy other than primary bladder cancer (e.g., prostate or colon cancer invading the bladder, or a gynecologic malignancy), or non-malignant disease (i.e., neurogenic bladder or radiation cystitis).
2
Not eligible for an orthotopic neobladder re-construction.
3
History of other malignancy (except skin cancer) within the previous 5 years.
For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.