BACKGROUND:Bladder cancer (BC) currently accounts for 5% of all malignancies and the most common tumor of the urinary tract. Diagnosis of bladder cancer is based on urine cytology and white-light cystoscopy (WLC) performed for patients with suspected bladder mass and÷or hematuria. Recent studies suggest that using the fluorescence photodynamic diagnosis (PDD) significantly improves diagnostic sensitivity with a positive influence upon the recurrence rate of bladder cancer. OBJECTIVE: To evaluate the diagnostic efficiency and long-term influence upon the tumor recurrence rate for patients with non-muscle-invasive bladder cancer (NMIBC) undergoing hexaminolevulinate PDD compared to standard WLC. PATIENTS, MATERIALS AND METHODS:Between 2009 and 2011, 113 primary NMIBC patients were enrolled in our prospective study and randomized in two parallel groups: 57 patients in the study group (PDD) and 56 patients in the control group (WLC). All patients had primary Ta÷T1 NMIBC with good life expectancy and no significant bladder outlet obstruction [postvoid residual urine volume (PVR) <100 mL]. RESULTS:Fluorescence cystoscopy examination identified 26.3% more tumors than the conventional examination (p=0.034) in the PDD group. Tumor recurrence rate analysis proved a significant reduction by up to 20% after five years of follow-up by using PDD [hazard ratio (HR) 0.566, 95% confidence interval (CI) 0.343-0.936; p=0.0267]. CONCLUSIONS: The use of PDD for patients with NMIBC results in a significant 26% diagnostic sensitivity improvement as well as superior patient prognosis and quality of life following conservative treatment by reducing the tumor recurrence rate with up to 20% after five years of follow-up.
RCT Entities:
BACKGROUND:Bladder cancer (BC) currently accounts for 5% of all malignancies and the most common tumor of the urinary tract. Diagnosis of bladder cancer is based on urine cytology and white-light cystoscopy (WLC) performed for patients with suspected bladder mass and÷or hematuria. Recent studies suggest that using the fluorescence photodynamic diagnosis (PDD) significantly improves diagnostic sensitivity with a positive influence upon the recurrence rate of bladder cancer. OBJECTIVE: To evaluate the diagnostic efficiency and long-term influence upon the tumor recurrence rate for patients with non-muscle-invasive bladder cancer (NMIBC) undergoing hexaminolevulinate PDD compared to standard WLC. PATIENTS, MATERIALS AND METHODS: Between 2009 and 2011, 113 primary NMIBC patients were enrolled in our prospective study and randomized in two parallel groups: 57 patients in the study group (PDD) and 56 patients in the control group (WLC). All patients had primary Ta÷T1 NMIBC with good life expectancy and no significant bladder outlet obstruction [postvoid residual urine volume (PVR) <100 mL]. RESULTS: Fluorescence cystoscopy examination identified 26.3% more tumors than the conventional examination (p=0.034) in the PDD group. Tumor recurrence rate analysis proved a significant reduction by up to 20% after five years of follow-up by using PDD [hazard ratio (HR) 0.566, 95% confidence interval (CI) 0.343-0.936; p=0.0267]. CONCLUSIONS: The use of PDD for patients with NMIBC results in a significant 26% diagnostic sensitivity improvement as well as superior patient prognosis and quality of life following conservative treatment by reducing the tumor recurrence rate with up to 20% after five years of follow-up.