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Sun, 20 May 2012 04:17:41 -0500
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UROLOGY jobs in "San Francisco Bay Area, California - Urology" - CA
Fri, 18 May 2012 12:15:44 -0600
An excellent, urology opportunity has become available in the San Francisco Bay area to join a very established 30 physician, multispecialty group. The incoming candidate will be associating with one
UROLOGY jobs in "Upper Eastern Shore of Maryland - Urologist" - MD
Fri, 18 May 2012 12:15:44 -0600
Office Based Urology Opportunity in Maryland Board Certified Urologist is sought to assist with the medical and administrative management and development of a urology practice. Ideal candidate would
Urology / Nephrology News From Medical News Today
Renal Denervation Lowers Blood Pressure In Kidney Disease Patients
Sat, 19 May 2012 00:00:00 -0700
Disrupting certain nerves in the kidneys can safely and effectively lower blood pressure in patients with chronic kidney disease (CKD) and hypertension, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN). The findings indicate that the procedure might improve CKD patients' heart health...
For Chronic Kidney Disease Patients, One Type Of Open Heart Surgery Is Safer Than The Other
Sat, 19 May 2012 00:00:00 -0700
One type of open heart surgery is likely safer than the other for chronic kidney disease (CKD) patients, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN). Open heart, or coronary artery bypass, surgery can be done two ways: on-pump or off-pump, depending on whether the patient is put on a heart-lung machine...
Molecule That Prevents Heart Damage is Also Proving Its Worth In Diabetic Patients
Fri, 18 May 2012 01:00:00 -0700
ACE2, a molecule that has been shown to prevent damage in the heart, is now proving to be protective of the major organs that are often damaged in diabetic patients. Gavin Oudit, a researcher with the Faculty of Medicine & Dentistry, and his colleagues at the University of Florida, found that lab models that lacked ACE2 had worse cardiovascular complications related to diabetes...
BMC Urology - Latest Articles
Effectiveness of intravenous lidocaine versus intravenous morphine for patients with renal colic in the emergency department
Hassan SoleimanpourKamaleddin HassanzadehHassan VaeziSamad GolzariRobab Mehdizadeh EsfanjaniMaryam Soleimanpour Fri, 04 May 2012 00:00:00 -0000
Background: Despite the fact that numerous medications have been introduced to treat renal colic, nonehas been proven to relieve the pain rapidly and thoroughly. In this study, we aimed atcomparing the effects of intravenous lidocaine versus intravenous morphine in patientssuffering from renal colic. Methods: In a prospective randomized double-blind clinical trial performed in the emergencydepartment of Imam Reza educational hospital of Tabriz, Iran, we studied 240 patients, 18-65 years old, who were referred due to renal colic. Patients were divided into two groups. Ingroup I (120 people) single-dose intravenous lidocaine (1.5 mg/kg) was administered and ingroup II (120 people) single-dose intravenous morphine (0.1 mg/kg) was administeredslowly. Visual Analogue Pain Scale (VAS) was recorded while admission, 5, 10, 15 and 30minutes after injection. Statistical data and results were studied using descriptive statistics aspercentage and Mean +/- SD. To compare the response to treatment, Mann-Whitney U-test wasused in two groups. Consequently, the data were analyzed using the SPSS16 software. Results: Pain score measured in two groups five minutes after the injection of lidocaine and morphinewere 65 % and 53 % respectively (95% CI 0.60 - 0.69, CI 0.48 - 0.57, p = 0.0002).108 (90 %)patients (95 % CI 0.84 - 0.95) from group I and 84 (70%) patients (95 % CI 0.62 - 0.78) fromgroup II responded appropriately at the end of the complete treatment. The difference wasstatistically significant (p = 0.0001). Conclusions: Changing the smooth muscle tone and reducing the transmission of afferent sensorypathways, lidocaine causes a significant reduction in pain.Trial registrationClinical Trials IRCT138901042496N3
IL-8 as a urinary biomarker for the detection of bladder cancer
Virginia UrquidiMyron ChangYunfeng DaiJeongsoon KimEdward WolfsonSteve GoodisonCharles Rosser Fri, 04 May 2012 00:00:00 -0000
Background: Current urine-based assays for bladder cancer (BCa) diagnosis lack accuracy, so the search for improved biomarkers continues. Through genomic and proteomic profiling of urine, we have identified a panel of biomarkers associated with the presence of BCa. In this study, we evaluated the utility of three of these biomarkers, interleukin 8 (IL-8), Matrix metallopeptidase 9 (MMP-9) and Syndecan in the diagnosis of BCa through urinalysis. Methods: Voided urines from 127 subjects, cancer subjects (n = 64), non-cancer subjects (n = 63) were analyzed. The protein concentrations of IL-8, MMP-9, and Syndecan were assessed by enzyme-linked immunosorbent assay (ELISA). Data were also compared to a commercial ELISA-based BCa detection assay (BTA-Trak(c)) and urinary cytology. We used the area under the curve of a receiver operating characteristic (AUROC) to compare the performance of each biomarker. Results: Urinary protein concentrations of IL-8, MMP-9 and BTA were significantly elevated in BCa subjects. Of the experimental markers compared to BTA-Trak(c), IL-8 was the most prominent marker (AUC; 0.79; 95% confidence interval [CI], 0.72-0.86). Multivariate regression analysis revealed that only IL-8 (OR; 1.51; 95% CI, 1.16-1.97, p = 0.002) was an independent factor for the detection of BCa. Conclusions: These results suggest that the measurement of IL-8 in voided urinary samples may have utility for urine-based detection of BCa. These findings need to be confirmed in a larger, prospective cohort.
Prospective Multi-Center Study of Oncologic Outcomes of Robot-Assisted Partial Nephrectomy for pT1 Renal Cell Carcinoma
Rachel KylloYoussef TanaghoJihad KaoukMichael StifelmanCraig RogersShahab HillyerShyam SukumarKenneth NeppleSam Bhayani Mon, 30 Apr 2012 00:00:00 -0000
Background: Partial nephrectomy has been increasingly recommended over radical nephrectomy for the management of small renal masses based on improved renal functional outcomes without sacrifice of oncologic effectiveness. Robot-assisted partial nephrectomy (RAPN) has been introduced in an effort to offer another minimally invasive option for nephron-sparing surgery. However, reports of RAPN have been limited to short-term perioperative outcomes. The goal of this study is to report and evaluate the initial oncologic outcomes of RAPN. Utilizing prospectively obtained data on RAPN performed by four surgeons at four separate tertiary care centers, we selected patients with unilateral, localized, non-familial, pathologically-confirmed pT1 renal cell carcinoma and a minimum post-operative follow-up of 12 months. Results: RAPN was performed in 124 patients with a median tumor size of 3.0 cm (IQR 2.2-4.2 cm). Median follow-up was 29 months (range 12-46 months). Positive parenchymal surgical margins occurred in two patients (1.6%), both of whom were recurrence-free at 30 and 34 months after surgery. The three-year Kaplan-Meier estimated disease-free survival was 94.9%, cancer-specific survival was 99.1%, and overall survival was 97.3%. Conclusions: In our cohort of patients with small renal carcinomas who were followed for a median of 29 months, recurrence and survival outcomes were similar to those reported for open and laparoscopic partial nephrectomy. Further long-term outcomes will be needed to definitively claim that RAPN is oncologically equivalent to other surgical approaches.
Stage I seminoma: Treatment outcomes at King Hussein Cancer Center in Jordan
Jamal KhaderAhmed SalemYazan AbuodehAbdelatief AlmousaNaim FarahFadwa Abdelrahman Tue, 24 Apr 2012 00:00:00 -0000
Background: The aim of this report is to address treatment outcomes of patients with early-stage seminoma in a single institution with special reference to patients with history of surgical violation of the scrotum. Methods: Seventy four patients with pure seminoma were treated at King Hussein Cancer Center (Amman, Jordan) between 2003 and 2010. All patients underwent orchiectomy. All but 3 patients received adjuvant radiotherapy. Patients who underwent surgical violation of the scrotum prior to referral were managed by further excision or irradiation of the scrotal scar. The follow-up ranged from 1 to 200 months (mean, 33 months). Results: At the time of follow-up; all but one patient remain alive. The 3-year relapse-free survival for the entire cohort was 95.9%. Three patients developed relapse, all of whom received adjuvant irradiation following inguinal orchiectomy and initially harbored tumors larger than 4cm upon pathological examination. Median time to relapse was 14 months (range, 8-25 months). None were associated with elevated tumor markers prior to detection of relapse. All but one patient were successfully salvaged by chemotherapy. Conclusions: Our results confirm the excellent prognosis for patients with early-stage seminoma treated by orchiectomy and adjuvant radiotherapy in a developing country. Although all patients who developed relapse demonstrated adverse pathological findings upon initial assessment, no consistent predictor of relapse was found. Scrotal scar re-excision or irradiation in patients with prior history of surgical violation of the scrotum are effective in preventing local failure.
Potential relevance of pre-operative quality of life questionnaires to identify candidates for surgical treatment of genital prolapse: a pilot study
Christian ChauvinElisabeth ChereauMarcos BallesterEmile Darai Tue, 27 Mar 2012 00:00:00 -0000
Background: To evaluate prolapse-related symptoms, quality of life and sexuality of patients with validated questionnaires before and after surgery for genital prolapse and assess relevance of such an evaluation to select women for surgery. Methods: From November 2009 to April 2010, 16 patients operated on for genital prolapse of grade greater than or equal to 2 (POP-Q classification) were evaluated prospectively by three questionnaires of quality of life Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Organ Prolaps/Urinary Incontinence Sexual Questionnaire (PISQ-12). Data were collected the day before surgery and 6 weeks postoperatively. Results: Eleven patients had laparoscopic surgery and five vaginal surgery. There was a significant decrease in pelvic heaviness, vaginal discomfort and urinary symptoms after surgery. The score of symptoms of prolapse, the PFDI-20 score was 98.5 preoperatively and 31.8 postoperatively (p < 0.0001). The score for quality of life, the PFIQ-7 score was 54.5 preoperatively and 7.4 postoperatively (p = 0.001). The score of sexuality, the PISQ-12 score was 35.3 preoperatively and 37.5 postoperatively (p = 0.1). Two of the 3 patients with a PFIQ 7 under or equal to 20 were not improved while all the women with a preoperative PFIQ-7 over 20 were improved after surgery. Conclusions: This study suggests that surgery improves quality of life of patients with genital prolapse. Quality of life questionnaires could help select good candidates for surgery. Further studies are required to determine threshold to standardize indications of surgery.
Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium
Maria GoossensFrank BuntinxSteven JoniauKoen AckaertFilip AmeyeIgnace BillietJohan BraeckmanAlex BreugelmansJochen DarrasKurt DilenLieven GoemanEliane KellenBertrand TombalSiska Van BruwaeneBen Van CleyenbreugelFrank Van der AaKris VekemansHendrik van PoppelMaurice Zeegers Wed, 21 Mar 2012 00:00:00 -0000
Background: In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence.MethodThe SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at http://www.seleblat.org. Patients are randomly assigned to selenium yeast (200 μg/day) supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study.DesignThe SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.DiscussionThis is the first report on a selenium randomized trial in bladder cancer patients.Trial registrationClinicalTrials.gov identifier: NCT00729287
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Urology jobs
Sun, 20 May 2012 04:17:41 -0500
All Urology jobs for Sun May 20 2012
UROLOGY jobs in "San Francisco Bay Area, California - Urology" - CA
Fri, 18 May 2012 12:15:44 -0600
An excellent, urology opportunity has become available in the San Francisco Bay area to join a very established 30 physician, multispecialty group. The incoming candidate will be associating with one
UROLOGY jobs in "Upper Eastern Shore of Maryland - Urologist" - MD
Fri, 18 May 2012 12:15:44 -0600
Office Based Urology Opportunity in Maryland Board Certified Urologist is sought to assist with the medical and administrative management and development of a urology practice. Ideal candidate would
Urology / Nephrology News From Medical News Today
Renal Denervation Lowers Blood Pressure In Kidney Disease Patients
Sat, 19 May 2012 00:00:00 -0700
Disrupting certain nerves in the kidneys can safely and effectively lower blood pressure in patients with chronic kidney disease (CKD) and hypertension, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN). The findings indicate that the procedure might improve CKD patients' heart health...
For Chronic Kidney Disease Patients, One Type Of Open Heart Surgery Is Safer Than The Other
Sat, 19 May 2012 00:00:00 -0700
One type of open heart surgery is likely safer than the other for chronic kidney disease (CKD) patients, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN). Open heart, or coronary artery bypass, surgery can be done two ways: on-pump or off-pump, depending on whether the patient is put on a heart-lung machine...
Molecule That Prevents Heart Damage is Also Proving Its Worth In Diabetic Patients
Fri, 18 May 2012 01:00:00 -0700
ACE2, a molecule that has been shown to prevent damage in the heart, is now proving to be protective of the major organs that are often damaged in diabetic patients. Gavin Oudit, a researcher with the Faculty of Medicine & Dentistry, and his colleagues at the University of Florida, found that lab models that lacked ACE2 had worse cardiovascular complications related to diabetes...
BMC Urology - Latest Articles
Effectiveness of intravenous lidocaine versus intravenous morphine for patients with renal colic in the emergency department
Hassan SoleimanpourKamaleddin HassanzadehHassan VaeziSamad GolzariRobab Mehdizadeh EsfanjaniMaryam Soleimanpour Fri, 04 May 2012 00:00:00 -0000
Background: Despite the fact that numerous medications have been introduced to treat renal colic, nonehas been proven to relieve the pain rapidly and thoroughly. In this study, we aimed atcomparing the effects of intravenous lidocaine versus intravenous morphine in patientssuffering from renal colic. Methods: In a prospective randomized double-blind clinical trial performed in the emergencydepartment of Imam Reza educational hospital of Tabriz, Iran, we studied 240 patients, 18-65 years old, who were referred due to renal colic. Patients were divided into two groups. Ingroup I (120 people) single-dose intravenous lidocaine (1.5 mg/kg) was administered and ingroup II (120 people) single-dose intravenous morphine (0.1 mg/kg) was administeredslowly. Visual Analogue Pain Scale (VAS) was recorded while admission, 5, 10, 15 and 30minutes after injection. Statistical data and results were studied using descriptive statistics aspercentage and Mean +/- SD. To compare the response to treatment, Mann-Whitney U-test wasused in two groups. Consequently, the data were analyzed using the SPSS16 software. Results: Pain score measured in two groups five minutes after the injection of lidocaine and morphinewere 65 % and 53 % respectively (95% CI 0.60 - 0.69, CI 0.48 - 0.57, p = 0.0002).108 (90 %)patients (95 % CI 0.84 - 0.95) from group I and 84 (70%) patients (95 % CI 0.62 - 0.78) fromgroup II responded appropriately at the end of the complete treatment. The difference wasstatistically significant (p = 0.0001). Conclusions: Changing the smooth muscle tone and reducing the transmission of afferent sensorypathways, lidocaine causes a significant reduction in pain.Trial registrationClinical Trials IRCT138901042496N3
IL-8 as a urinary biomarker for the detection of bladder cancer
Virginia UrquidiMyron ChangYunfeng DaiJeongsoon KimEdward WolfsonSteve GoodisonCharles Rosser Fri, 04 May 2012 00:00:00 -0000
Background: Current urine-based assays for bladder cancer (BCa) diagnosis lack accuracy, so the search for improved biomarkers continues. Through genomic and proteomic profiling of urine, we have identified a panel of biomarkers associated with the presence of BCa. In this study, we evaluated the utility of three of these biomarkers, interleukin 8 (IL-8), Matrix metallopeptidase 9 (MMP-9) and Syndecan in the diagnosis of BCa through urinalysis. Methods: Voided urines from 127 subjects, cancer subjects (n = 64), non-cancer subjects (n = 63) were analyzed. The protein concentrations of IL-8, MMP-9, and Syndecan were assessed by enzyme-linked immunosorbent assay (ELISA). Data were also compared to a commercial ELISA-based BCa detection assay (BTA-Trak(c)) and urinary cytology. We used the area under the curve of a receiver operating characteristic (AUROC) to compare the performance of each biomarker. Results: Urinary protein concentrations of IL-8, MMP-9 and BTA were significantly elevated in BCa subjects. Of the experimental markers compared to BTA-Trak(c), IL-8 was the most prominent marker (AUC; 0.79; 95% confidence interval [CI], 0.72-0.86). Multivariate regression analysis revealed that only IL-8 (OR; 1.51; 95% CI, 1.16-1.97, p = 0.002) was an independent factor for the detection of BCa. Conclusions: These results suggest that the measurement of IL-8 in voided urinary samples may have utility for urine-based detection of BCa. These findings need to be confirmed in a larger, prospective cohort.
Prospective Multi-Center Study of Oncologic Outcomes of Robot-Assisted Partial Nephrectomy for pT1 Renal Cell Carcinoma
Rachel KylloYoussef TanaghoJihad KaoukMichael StifelmanCraig RogersShahab HillyerShyam SukumarKenneth NeppleSam Bhayani Mon, 30 Apr 2012 00:00:00 -0000
Background: Partial nephrectomy has been increasingly recommended over radical nephrectomy for the management of small renal masses based on improved renal functional outcomes without sacrifice of oncologic effectiveness. Robot-assisted partial nephrectomy (RAPN) has been introduced in an effort to offer another minimally invasive option for nephron-sparing surgery. However, reports of RAPN have been limited to short-term perioperative outcomes. The goal of this study is to report and evaluate the initial oncologic outcomes of RAPN. Utilizing prospectively obtained data on RAPN performed by four surgeons at four separate tertiary care centers, we selected patients with unilateral, localized, non-familial, pathologically-confirmed pT1 renal cell carcinoma and a minimum post-operative follow-up of 12 months. Results: RAPN was performed in 124 patients with a median tumor size of 3.0 cm (IQR 2.2-4.2 cm). Median follow-up was 29 months (range 12-46 months). Positive parenchymal surgical margins occurred in two patients (1.6%), both of whom were recurrence-free at 30 and 34 months after surgery. The three-year Kaplan-Meier estimated disease-free survival was 94.9%, cancer-specific survival was 99.1%, and overall survival was 97.3%. Conclusions: In our cohort of patients with small renal carcinomas who were followed for a median of 29 months, recurrence and survival outcomes were similar to those reported for open and laparoscopic partial nephrectomy. Further long-term outcomes will be needed to definitively claim that RAPN is oncologically equivalent to other surgical approaches.
Stage I seminoma: Treatment outcomes at King Hussein Cancer Center in Jordan
Jamal KhaderAhmed SalemYazan AbuodehAbdelatief AlmousaNaim FarahFadwa Abdelrahman Tue, 24 Apr 2012 00:00:00 -0000
Background: The aim of this report is to address treatment outcomes of patients with early-stage seminoma in a single institution with special reference to patients with history of surgical violation of the scrotum. Methods: Seventy four patients with pure seminoma were treated at King Hussein Cancer Center (Amman, Jordan) between 2003 and 2010. All patients underwent orchiectomy. All but 3 patients received adjuvant radiotherapy. Patients who underwent surgical violation of the scrotum prior to referral were managed by further excision or irradiation of the scrotal scar. The follow-up ranged from 1 to 200 months (mean, 33 months). Results: At the time of follow-up; all but one patient remain alive. The 3-year relapse-free survival for the entire cohort was 95.9%. Three patients developed relapse, all of whom received adjuvant irradiation following inguinal orchiectomy and initially harbored tumors larger than 4cm upon pathological examination. Median time to relapse was 14 months (range, 8-25 months). None were associated with elevated tumor markers prior to detection of relapse. All but one patient were successfully salvaged by chemotherapy. Conclusions: Our results confirm the excellent prognosis for patients with early-stage seminoma treated by orchiectomy and adjuvant radiotherapy in a developing country. Although all patients who developed relapse demonstrated adverse pathological findings upon initial assessment, no consistent predictor of relapse was found. Scrotal scar re-excision or irradiation in patients with prior history of surgical violation of the scrotum are effective in preventing local failure.
Potential relevance of pre-operative quality of life questionnaires to identify candidates for surgical treatment of genital prolapse: a pilot study
Christian ChauvinElisabeth ChereauMarcos BallesterEmile Darai Tue, 27 Mar 2012 00:00:00 -0000
Background: To evaluate prolapse-related symptoms, quality of life and sexuality of patients with validated questionnaires before and after surgery for genital prolapse and assess relevance of such an evaluation to select women for surgery. Methods: From November 2009 to April 2010, 16 patients operated on for genital prolapse of grade greater than or equal to 2 (POP-Q classification) were evaluated prospectively by three questionnaires of quality of life Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Organ Prolaps/Urinary Incontinence Sexual Questionnaire (PISQ-12). Data were collected the day before surgery and 6 weeks postoperatively. Results: Eleven patients had laparoscopic surgery and five vaginal surgery. There was a significant decrease in pelvic heaviness, vaginal discomfort and urinary symptoms after surgery. The score of symptoms of prolapse, the PFDI-20 score was 98.5 preoperatively and 31.8 postoperatively (p < 0.0001). The score for quality of life, the PFIQ-7 score was 54.5 preoperatively and 7.4 postoperatively (p = 0.001). The score of sexuality, the PISQ-12 score was 35.3 preoperatively and 37.5 postoperatively (p = 0.1). Two of the 3 patients with a PFIQ 7 under or equal to 20 were not improved while all the women with a preoperative PFIQ-7 over 20 were improved after surgery. Conclusions: This study suggests that surgery improves quality of life of patients with genital prolapse. Quality of life questionnaires could help select good candidates for surgery. Further studies are required to determine threshold to standardize indications of surgery.
Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium
Maria GoossensFrank BuntinxSteven JoniauKoen AckaertFilip AmeyeIgnace BillietJohan BraeckmanAlex BreugelmansJochen DarrasKurt DilenLieven GoemanEliane KellenBertrand TombalSiska Van BruwaeneBen Van CleyenbreugelFrank Van der AaKris VekemansHendrik van PoppelMaurice Zeegers Wed, 21 Mar 2012 00:00:00 -0000
Background: In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence.MethodThe SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at http://www.seleblat.org. Patients are randomly assigned to selenium yeast (200 μg/day) supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study.DesignThe SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.DiscussionThis is the first report on a selenium randomized trial in bladder cancer patients.Trial registrationClinicalTrials.gov identifier: NCT00729287

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