Bladder Tumor Biopsy Study to Improve Preoperative Determination of Stage and Grade

Inclusion Criteria:

• Male or females, age 21 or older;
• Clinical evidence of urothelial carcinoma of the bladder;
• Clinically (endoscopic, by physical examination, and/or axial-imaging) deemed non-muscle-invasive tumor of the bladder (cTis-Ta-T1), of any grade, single or multiple, at initial occurrence or recurrent with >12 months interval free of disease;
• Surgically eligible for the TUR;
• Patient or authorized proxy needs to have signed the informed consent form.

Exclusion Criteria:

• History of any muscle-invasive or non-organ confined bladder tumors (T2 or higher);
• Patients with sessile appearing bladder tumors, which may be T2 or higher stage;
• Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract;
• Concurrent use of anticoagulation medication or chronic use of NSAIDs, including aspirin (other than cardio protective doses of 80mg daily) that has not been appropriately interrupted before the office cystoscopic evaluation;
• Patient deemed medically or psychologically unfit for the surgical procedure;
• Subject has received any investigational medication within 30 days prior to the registration or is scheduled to receive an investigational drug during the course of the study;

Women Exclusion

• Pregnant or lactating women.