Outpatient Photodynamic Diagnosis-guided Laser Destruction of Bladder Tumors Is as Good as Conventional Inpatient Photodynamic Diagnosis-guided Transurethral Tumor Resection in Patients with Recurrent Intermediate-risk Low-grade Ta Bladder Tumors. A Prospective Randomized Noninferiority Clinical Trial.

BACKGROUND: Transurethral resection of recurrent low-grade intermediate-risk Ta bladder tumor (BT) in general anesthesia (GA) is burdensome to patients and health care system. Laser technologies enable treatment in office-based settings, reducing morbidity and costs. OBJECTIVE: To compare 4-mo recurrence-free survival after outpatient department (OPD) diode laser coagulation of BT in local anesthesia and gold standard transurethral resection of BT (TUR-BT) in GA in intermediate-risk Ta low-grade BT, and to evaluate treatment-related morbidity. DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized noninferiority trial with 4-mo follow-up, in the hospital setting, was conducted in Capital Region of Denmark from 2016 to 2020. Participants were patients with histologically verified Ta low-grade BT recurrence. A total of 206 patients were randomized; 176 finished treatment and follow-up as per protocol. INTERVENTION: Laser photocoagulation of bladder tumor (PC-BT) in OPD using a 980 nm diode laser compared with gold standard TUR-BT in GA, both performed with photodynamic diagnosis (PDD) guidance. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Four-month recurrence-free survival was assessed; predefined inferiority criterion was set at 15%. The secondary outcomes were pain during PC-BT, postoperative morbidity, postoperative complications, and patient's preference. RESULTS AND LIMITATIONS: Four-month recurrence-free survival was 8% higher after PC-BT (95% confidence interval [CI]: -8% to 24%). The predefined noninferiority criterion was met. Pain score (1-10) during PC-BT was 2.4 (interquartile range 0.8-3.3). Postoperative lower urinary tract symptom score (0-100) was 13.9 points higher (95% CI: 6.9-21.0, p < 0.001) in the group with transurethral resection of the bladder. The frequency of minor complications was 8.1% higher after TUR-BT (95% CI: 1.0-14.6%, p = 0.026). Of the patients, 98% (95% CI: 92-100%) preferred PC-BT. CONCLUSIONS: PDD-guided PC-BT in OPD is as good as TUR-BT in GA to remove recurrent low-grade Ta BT. Postoperative quality of life is better after PC-BT and the frequency of minor complications was lower. PATIENT SUMMARY: This study evaluates the efficacy of outpatient laser removal of low-grade noninvasive bladder tumor. Outpatient tumor removal with laser was as good as transurethral resection in general anesthesia and less burdensome to patients.

Haematuria and urinary tract cancers in patients with atrial fibrillation treated with oral anticoagulants.

AIMS: Patients with atrial fibrillation (AF) treated with oral anticoagulants (OACs) have an increased risk of bleeding including haematuria. In the general population, gross haematuria is associated with urinary tract cancer. Consequently, we aimed to investigate the potential association between gross haematuria and urinary tract cancer in anticoagulated patients with AF. METHODS AND RESULTS: Using Danish nationwide registers, we included Danish AF patients treated with OACs between 2001 and 2015. Non-parametric estimation and semi-parametric absolute risk regression were used to estimate the absolute risk of urinary tract cancer in patients with and without gross haematuria. We included 125 063 AF patients with a median age of 74 years (interquartile range 65-80) and a majority of males (57%). The absolute risk of gross haematuria 12 months after treatment initiation increased with age ranging from 0.37% [95% confidence interval (CI) 0.31-0.42] to 0.85% (95% CI 0.75-0.96) in the youngest and oldest age groups of ≤70 and >80 years of age, respectively. The 1-year risk of urinary tract cancer after haematuria ranged from 4.2% (95% CI 2.6-6.6) to 6.5% (95% CI 4.6-9.0) for patients in age group >80 and 71-80 years, respectively. Gross haematuria conferred large risk ratios of urinary tract cancer when comparing patients with and without haematuria across all age groups. CONCLUSION: Gross haematuria was associated with clinically relevant risks of urinary tract cancer in anticoagulated patients with AF. These findings underline the importance of meticulously examining anticoagulated patients with haematuria.

Do repeated transurethral procedures under general anesthesia influence mortality in patients with non-invasive urothelial bladder cancer? A Danish national cohort study.

Purpose: To investigate the effect of repeated transurethral procedures under general anesthesia on overall mortality in patients with non-invasive bladder cancer.Materials and methods: All Danish residents with non-invasive papillary urothelial carcinoma or primary urothelial carcinoma in situ diagnosed between 1 January 2000 and 1 January 2011 were included and followed until death or 31 March 2017. All transurethral procedures under general anesthesia, intravesical instillation therapy, recurrences and progression to invasive disease or cystectomy were recorded during follow-up. Associations between treatments and overall mortality were evaluated using multivariable regression analysis adjusted for age, gender, comorbidities and socioeconomic status. The effect of disease progression on mortality was removed by censoring patients at the time of progression or cystectomy.Results: Risk of death increased with the number of transurethral procedures under general anesthesia for Ta low- and high-grade tumors compared to patients who had only one procedure; after eight or more procedures the risk of death increased by 28% and 83%, respectively. There was no similar relationship for carcinomas in situ. In total, 36-52% of procedures under general anesthesia did not identify urothelial neoplasia.Conclusions: Repeated transurethral procedures under general anesthesia appear to be associated with increased risk of death in patients with primary non-invasive papillary urothelial carcinoma. Furthermore, a substantial number of procedures were without findings of neoplasia, indicating that too many patients are admitted for transurethral procedures under GA. Attempts should be taken to reduce unnecessary transurethral procedures under GA, e.g. by improved outpatient diagnosis of urothelial neoplasia.

National incidence and survival of patients with non-invasive papillary urothelial carcinoma: a Danish population study.

OBJECTIVE: To estimate national relative survival of low and high grade non-invasive papillary urothelial carcinoma (Ta LG and Ta HG) and urothelial carcinoma in situ (CIS). MATERIALS AND METHODS: All Danish citizens (17,941 patients) with a primary urothelial bladder tumour diagnosis in the period 2000- 2010 were followed until 1 January 2016 and recorded in the Danish Bladder Cancer Cohort database. Survival was compared to the background population matched on age and gender and adjusted by civil status, income, education, and comorbidity. RESULTS: Patients treated in daily practice with Ta LG have 46% (HR = 1.46 (1.42-1.51) p < 0.001) higher risk of death compared to a background population matched for age and gender. This risk of death ceases to 28% (HR = 1.28 (1.24-1.32) p < 0.001) after adjustment for civil status, income, education, and comorbidity. Relative survival of Ta LG patients is 0.94 (0.93-0.95). These estimates are constant throughout the observation period. Significantly higher mortality is found for patients with Ta HG and CIS, but, in contrast to Ta LG, the relative risk of death of Ta HG (HR = 1.79 (1.69-1.90) p < 0.001) and CIS (HR = 2.02 (1.79-2.26) p < 0.001) decreases considerably after 5 years survival (HR = 1.43 (1.30-1.57) p < 0.001 and HR = 1.64 (1.36-1.98) p < 0.001, respectively). CONCLUSION: Patients with Ta LG have a continuous lower survival and a 28% higher risk of death at any time compared to a matched background population when treated in daily practice.