J Urol Vol.161, 443-446, February 1999

DOV PODE, AMOS SHAPIRO, MOSHE WALD, OFER NATIV, MENACHEM LAUFER and ISSAC KAVER

From the Departments of Urology, Hadassah Medical Center, Hebrew University, Jerusalem, Bnai Zion Medical Center, Haifa and Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv, Isreal

Purpose: We assess the sensitivity and specificity of the noninvasive BTA stat* urine test for detection of primary and recurrent bladder cancer with special reference to the size, grade and stage of the tumors, and examine the effect of intravesical bacillus Calmette-Guerin treatment on the results.

Materials and Methods: A total of 250 patients recruited from 3 medical centers provided voided urine samples for the BTA stat test and cytopathological study. Of these patients 162 were monitored following resection of bladder tumors and 88 were evaluated for the first time for hematuria or irritative voiding symptoms. Each patient underwent cystoscopy. Biopsies were obtained when a bladder tumor was seen or if carcinoma in situ was suspected. The sensitivity, specificity and accuracy of the BTA stat test were compared to standard voided urine cytology.

Results: No tumor was found in 122 patients, primary transitional cell carcinoma was found in 71 and cystoscopy revealed recurrent tumors in 57. Overall sensitivity of the BTA stat test was 82.8% and specificity was 68.9%. Sensitivity of urine cytology was 39.8% and specificity was 95.1%. The BTA stat test detected 90.1% of the primary and 73.7% of the recurrent tumors. All patients with carcinoma in situ, high grade tumors, muscle invasive cancer and tumors larger than 2 cm. were diagnosed by the BTA stat test.
Conclusions: The BTA stat test can be used as a screening test for bladder cancer in patients with hematuria or irritative voiding symptoms and for surveillance of those who have not been treated with intravesical bacillus Calmette-Guerin.

* Bard Diagnostics, Redmond, Washington.