Multidisciplinary consensus document on the current treatment of bacille Calmette-Guérin-unresponsive non-muscle invasive bladder tumor.

Radical cystectomy is the current treatment of choice for patients with BCG-unresponsive non-muscle invasive bladder tumor (NMIBC). However, the high comorbidity of this surgery and its effects on the quality of life of patients require the investigation and implementation of bladder-sparing treatment options. These must be evaluated individually by the uro-oncology committee based on the characteristics of the BCG failure, type of tumor, patient preferences and treatment options available in each center. Based on FDA-required oncologic outcomes (6-month complete response rate for CIS: 50%; duration of response in responders for CIS and papillary: 30% at 12 months and 25% at 18 months), there is not currently a strong preference for one treatment over another, although the intravesical route seems to offer less toxicity. This work summarizes the evidence on the management of BCG-unresponsive NMIBC based on current scientific evidence and provides consensus recommendations on the most appropriate treatment.

Clinical Usefulness of Prostate-specific Membrane Antigen-ligand Positron Emission Tomography/Computed Tomography for the Detection of Prostate Cancer Biochemical Recurrence after Primary Radiation Therapy in Patients with Prostate-specific Antigen Below the Phoenix Threshold: Systematic Review and Meta-analysis.

AIMS: After primary radiotherapy, biochemical recurrence is defined according to the Phoenix criteria as a prostate-specific antigen (PSA) value >2 ng/ml relative to the nadir. Several studies have shown that prostate-specific membrane antigen (PSMA)-ligand positron emission tomography/computed tomography (PET/CT) can help in detecting recurrence in patients with low PSA values. This study aimed to assess the detection rate and patterns of PSMA-ligand PET/CT uptake in patients with suspected biochemical recurrence after primary radiotherapy and with PSA levels below the Phoenix threshold. MATERIALS AND METHODS: The meta-analysis was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Articles providing data on patients with suspected prostate cancer recurrence after primary radiotherapy with a PSA value below the Phoenix threshold and who underwent PSMA-ligand PET/CT were included. Quality assessment was carried out using the Quality Assessment of Diagnostic Accuracy Studies-2 tool (QUADAS-2). RESULTS: In total, five studies were included, recruiting 909 patients (202 with PSA ≤2 ng/ml). The PSMA-ligand detection rate in the patients with ≤2 ng/ml ranged from 66 to 83%. The most frequent source of PSMA-ligand PET/CT uptake was local recurrence, followed by lymph node metastasis and bone metastasis. PSMA-ligand PET/CT uptake due to local-only recurrence was more likely in patients with PSA ≤2 ng/ml compared with PSA > 2 ng/ml: risk ratio 0.72 (95% confidence interval 0.58-0.89), P = 0.003. No significant differences were observed in the detection of PSMA-ligand uptake in other areas. Limitations include a lack of biopsy confirmation, cohort reports with small sample sizes and a potentially high risk of bias. CONCLUSION: A significant detection of PSMA-ligand-avid disease was observed in patients with PSA levels below the Phoenix threshold. There was a higher likelihood of detecting local-only uptake when the PSA value was ≤2 ng/ml. The findings suggest that a critical review of the Phoenix criteria may be warranted in the era of PSMA-ligand PET/CT and highlight the need for further prospective trials.

Tratamientos actuales tras fracaso a BCG en cáncer de vejiga no músculo-invasivo / Current treatments for BCG failure in non-muscle invasive bladder cancer (NMIBC)

INTRODUCCIÓN: El tratamiento de elección para el cáncer vesical no músculo infiltrante (CVNMI) de alto riesgo es el bacilo de Calmette-Guérin (BCG). Sin embargo, cuando éste falla, el tratamiento indicado es la cistectomía radical. En los últimos años se están desarrollando ensayos con diversos fármacos para evitar esta cirugía en pacientes con fracaso a BCG. El objetivo de este artículo es llevar a cabo una puesta al día de los tratamientos en estudio para la preservación vesical en esta población de pacientes. Material y MÉTODOS: Revisión no sistemática, realizando una búsqueda en PubMed con los términos "Bladder cancer", "Non-muscle invasive bladder cancer", "NMIBC", "BCG", "BCG-refractory", "Mitomycin C", "MMC", "Hyperthermia", "Electromotive Drug Administration", "EMDA" Empleamos los buscadores clinicaltrials.gov y clinicaltrialsregister.eu para localizar ensayos clínicos. RESULTADOS: El único fármaco intravesical aprobado por la Food and Drug Administration (FDA) para carcinoma in situ (CIS) tras fracaso a BCG es la valrubicina. Recientemente la FDA ha aprobado pembrolizumab intravenoso, tras la publicación de los datos preliminares del estudio KEYNOTE-057. Atezolizumab ha demostrado unos resultados preliminares similares de eficacia. En las guías europeas se reconoce como alternativa únicamente la quimiohipertermia inducida por microondas y EMDA-MMC (electromotive drug administration). Otras alternativas en investigación son los taxanos y la gemcitabina, solos o en combinación, los virus recombinantes y la quimiohipertermia intravesical asistida por dispositivos. CONCLUSIONES: Los resultados de los nuevos fármacos son prometedores, con gran número de ensayos en marcha. Conocer los mecanismos de resistencia a BCG es imprescindible para la exploración de nuevas alternativas terapéuticas

INTRODUCTION: The treatment of choice for high-risk non-muscle invasive bladder cancer (NMIBC) is bacillus Calmette-Guérin (BCG). However, when this fails, the indicated treatment is radical cystectomy. In recent years, trials are being developed with various drugs to avoid this surgery in patients with BCG failure. The aim of this article is to update the treatments under study for bladder preservation in this patient population. MATERIAL AND METHODS: Non-systematic review, searching PubMed with the terms "Bladder cancer", "Non-muscle invasive bladder cancer", "NMIBC", "BCG", "BCG-refractory", "Mitomycin C", "MMC", "Hyperthermia", "Electromotive Drug Administration", "EMDA" We used the search engines clinicaltrials.gov and clinicaltrialsregister.eu to find clinical trials. RESULTS: The only intravesical drug approved by the Food and Drug Administration (FDA) for carcinoma in situ (CIS) after failure to BCG is valrubicin. Recently, the FDA has approved intravenous pembrolizumab, following the publication of preliminary data from the KEYNOTE-057 study. Atezolizumab has demonstrated similar preliminary efficacy results. Only microwave-induced chemohyperthermia and EMDA-MMC (electromotive drug administration) are recognized as alternatives in European guidelines. Other options under investigation are taxanes and gemcitabine, alone or in combination, recombinant viruses and device-assisted intravesical chemohyperthermia. CONCLUSIONS: The results of new drugs are promising, with a large number of trials underway. Knowing the mechanisms of resistance to BCG is essential to explore new therapeutic options

Estudio de las infecciones relacionadas con la asistencia sanitaria tras la realización de cistectomía radical / Evaluation of health care-associated infections following radical cystectomy

INTRODUCCIÓN Y OBJETIVO: La cistectomía radical es una cirugía compleja con una alta tasa de complicaciones, entre ellas las infecciones, conllevando un aumento de la morbimortalidad, estancia hospitalaria y costes. El objetivo de este trabajo es estudiar las infecciones relacionadas con la asistencia sanitaria (IRAS) en estos pacientes, así como de los microorganismos asociados, perfiles de resistencia antibiótica y factores de riesgo. MATERIAL Y MÉTODOS: Estudio prospectivo del 2012 al 2017. Se recogen variables epidemiológicas, comorbilidades y variables quirúrgicas. Se analizan los microorganismos implicados y patrones de susceptibilidad antibiótica. RESULTADOS: Estudio de 122 pacientes. Edad media 67 años (DE:18,42). Estancia hospitalaria media 23,5 días (18,42). Tasa de IRAS del 45%, predominando las infecciones del tracto urinario (43%) y de la herida quirúrgica (31%). Cultivos positivos en el 78,6% de los casos. Mayor aislamiento de Enterococcus (18%) y Escherichia coli (13%). El 43% de los microorganismos presentaban resistencia a la amoxicilina/ampicilina, 23% a las betalactamasas y 36% a las quinolonas. El tratamiento empírico fue adecuado en el 87,5%. Se observa un aumento en la estancia hospitalaria (17 días, p < 0,05) por padecer una IRAS. Menor tasa de complicaciones infecciosas en el abordaje laparoscópico frente al abierto (p < 0,001) y en las derivaciones ortotópicas frente al conducto ileal (p = 0,04). CONCLUSIONES: Encontramos una elevada tasa de IRAS en nuestra serie de cistectomías radicales, con un predominio de infecciones del tracto urinario y de la herida quirúrgica. E. coli y Enterococcus spp. son los microorganismos más frecuentemente aislados, con altas tasas de resistencia a algunos antibióticos de uso común

INTRODUCTION AND OBJECTIVE: Radical cystectomy is a complex surgery with a high rate of complications including infections, which lead to increased morbidity and mortality, longer hospital stay and higher costs. The aim of this work is to evaluate health care-associated infections (HAIs) in these patients, as well as associated microorganisms, antibiotic resistance profiles and risk factors. MATERIAL AND METHODS: Prospective study from 2012 to 2017. Epidemiologic variables, comorbidities and surgical variables are collected. The microorganisms involved and antibiotic susceptibility patterns are analyzed. RESULTS: 122 patients. Mean age 67 (SD:18,42). Mean hospital stay 23.5 days (18.42). HAIs rate of 45%, with predominant urinary tract infections (43%) and surgical wound infections (31%). Positive cultures in 78.6% of cases. Increased isolation of Enterococcus (18%) and Escherichia coli (13%). Forty-three percent of microorganisms were resistant to amoxicillin/ampicillin, 23% to beta-lactamases and 36% to quinolones. Empirical treatment was adequate in 87.5%. Hospital stay is increased (17 days, p < 0.05) due to HAIs. Lower rate of infectious complications in the laparoscopic vs. open approach (p < 0.001) and in orthotopic vs. ileal conduit diversion (p = 0.04) CONCLUSIONS: We found a high rate of HAIs in our radical cystectomy series, with predominant urinary tract and surgical wound infections. E.coli and Enterococcus spp. are the most frequently isolated microorganisms, with high rates of resistance to some commonly used antibiotics

Recent advances in neoadjuvant immunotherapy for urothelial bladder cancer: What to expect in the near future.

Urothelial bladder cancer (UC) is the most common malignancy involving the urinary system and represents a significant health problem. Immunotherapy has been used for decades for UC with intravesical bacillus Calmette-Guérin (BCG) set as the standard of care for non-muscle-invasive bladder cancer (NMIBC). The advent of immune checkpoint inhibitors (ICIs) has completely transformed the treatment landscape of bladder cancer enabling to expand the treatment strategies. Novel ICIs have successfully shown improved outcomes on metastatic disease to such an extent that the standard of care paradigm has changed leading to the development of different trials with the aim of determining whether ICIs may have a role in early disease. The localized muscle-invasive bladder cancer (MIBC) scenario remains challenging since the recurrence rate continues to be high despite all therapeutic efforts. This article will review the current experience of ICIs in the neoadjuvant setting of UC, the clinical trials landscape and finally, an insight of what to expect in the immediate and mid-term future.

Current treatments for BCG failure in non-muscle invasive bladder cancer (NMIBC). / Tratamientos actuales tras fracaso a BCG en cáncer de vejiga no músculo-invasivo.

The treatment of choice for high-risk non-muscle invasive bladder cancer (NMIBC) is bacillus Calmette-Guérin (BCG). However, when this fails, the indicated treatment is radical cystectomy. In recent years, trials are being developed with various drugs to avoid this surgery in patients with BCG failure. The aim of this article is to update the treatments under study for bladder preservation in this patient population. Non-systematic review, searching PubMed with the terms "Bladder cancer", "Non-muscle invasive bladder cancer", "NMIBC", "BCG", "BCG-refractory", "Mitomycin C", "MMC", "Hyperthermia", "Electromotive Drug Administration", "EMDA". We used the search engines clinicaltrials.gov and clinicaltrialsregister.eu to find clinical trials. The only intravesical drug approved by the Food and Drug Administration (FDA) for carcinoma in situ (CIS) after failure to BCG is Valrubicin. Recently, the FDA has approved intravenous Pembrolizumab, following the publication of preliminary data from the KEYNOTE-057 study. Atezolizumab has demonstrated similar preliminary efficacy results. Only microwave-induced chemohyperthermia and EMDA-MMC (Electromotive Drug Administration) are recognized as alternatives in European guidelines. Other options under investigation are taxanes and gemcitabine, alone or in combination, recombinant viruses and device-assisted intravesical chemohyperthermia. The results of new drugs are promising, with a large number of trials underway. Knowing the mechanisms of resistance to BCG is essential to explore new therapeutic options.

Evaluation of health care-associated infections following radical cystectomy. / Estudio de las infecciones relacionadas con la asistencia sanitaria tras la realización de cistectomía radical.

INTRODUCTION AND OBJECTIVE: Radical cystectomy is a complex surgery with a high rate of complications including infections, which lead to increased morbidity and mortality, longer hospital stay and higher costs. The aim of this work is to evaluate health care-associated infections (HAIs) in these patients, as well as associated microorganisms, antibiotic resistance profiles and risk factors. MATERIAL AND METHODS: Prospective study from 2012 to 2017. Epidemiologic variables, comorbidities and surgical variables are collected. The microorganisms involved and antibiotic susceptibility patterns are analyzed. RESULTS: 122 patients. Mean age 67 (SD:18,42). Mean hospital stay 23.5 days (18.42). HAIs rate of 45%, with predominant urinary tract infections (43%) and surgical wound infections (31%). Positive cultures in 78.6% of cases. Increased isolation of Enterococcus (18%) and Escherichia coli (13%). Forty-three percent of microorganisms were resistant to amoxicillin/ampicillin, 23% to beta-lactamases and 36% to quinolones. Empirical treatment was adequate in 87.5%. Hospital stay is increased (17 days, p< 0.05) due to HAIs. Lower rate of infectious complications in the laparoscopic vs. open approach (p< 0.001) and in orthotopic vs. ileal conduit diversion (p = 0.04) CONCLUSIONS: We found a high rate of HAIs in our radical cystectomy series, with predominant urinary tract and surgical wound infections. E.coli and Enterococcus spp. are the most frequently isolated microorganisms, with high rates of resistance to some commonly used antibiotics.

Nuevas inmunoterapias en el cáncer de vejiga no músculo-invasivo de alto riesgo: estado actual y perspectivas de futuro / New immunotherapies for high-risk non-muscle invasive bladder cancer: Current state and future perspectives

CONTEXTO: El tratamiento estándar de los tumores de vejiga no músculo-invasivos (TVNMI) de alto riesgo es la resección transuretral de vejiga e instilaciones de bacilo de Calmette-Guérin (BCG). Sin embargo, las respuestas son limitadas. Es necesario buscar nuevas alternativas terapéuticas para estos pacientes. Los resultados en tumores avanzados de los inhibidores de puntos de control han dado lugar al interés en el uso de estas moléculas en TVNMI. MÉTODOS: Hemos realizado una búsqueda en PubMed utilizando los términos «bladder cancer» y «check point inhibitors». Para la búsqueda de ensayos clínicos, hemos utilizado los buscadores clinicaltrials.gov y clinicaltrialsregister.eu RESULTADOS: Actualmente hay 5 ensayos en marcha de pacientes no tratados con BCG. No hay resultados disponibles. En cuanto a los pacientes no respondedores a BCG, existen 15 ensayos en marcha, 2 de ellos con resultados preliminares: el Keynote 057, con resultados prometedores con pembrolizumab y que ha llevado a la FDA a aprobar su uso en enero de 2020 y el SWOG S1605, que ha mostrado resultados similares con atezolizumab. Otros ensayos administran estos fármacos intravesicalmente, una opción atractiva si resulta efectiva para el control oncológico. CONCLUSIONES: Los inhibidores de puntos de control ofrecen una nueva posibilidad para los pacientes no respondedores al BCG. Probablemente en el futuro se podrán usar en pacientes no tratados previamente con BCG. Los datos preliminares de ensayos clínicos muestran resultados prometedores. Es importante un buen conocimiento de estas moléculas por los urólogos y la formación de equipos multidisciplinares para ofrecer las mejores alternativas terapéuticas a estos pacientes

BACKGROUND: The standard treatment for high-risk non-muscle invasive bladder tumors (NMIBT) is transurethral resection of the bladder and BCG instillations. However, responses are limited, and new therapeutic alternatives for these patients are required. The results of checkpoint inhibitors in advanced tumors have led to interest in the use of these molecules in NMIBT. METHODS: We conducted a search on PubMed using the terms «bladder cancer» and «check point inhibitors». We have used the search engines clinicaltrials.gov and clinicaltrialsregister.eu for the search of clinical trials. RESULTS: There are currently 5 trials in progress on BCG untreated patients. There are no results available. As for BCG non-responders, there are 15 ongoing trials, two of them with preliminary results: Keynote 057, with promising results with pembrolizumab, which has led the FDA to approve its use in January 2020, and SWOG S1605, which has shown similar results with atezolizumab. Other trials are using intravesical administration of these drugs, which is an attractive option if it is effective for cancer control. CONCLUSIONS: Checkpoint inhibitors offer a new possibility for patients who do not respond to BCG. These will probably be used in the future for previously BCG untreated patients. Preliminary data from clinical trials show promising results. A good understanding of these molecules by urologists and the creation of multidisciplinary teams are crucial in order to offer the best therapeutic alternatives to these patients

New immunotherapies for high-risk non-muscle invasive bladder cancer: Current state and future perspectives. / Nuevas inmunoterapias en el cáncer de vejiga no músculo-invasivo de alto riesgo: estado actual y perspectivas de futuro.

BACKGROUND: The standard treatment for high-risk non-muscle invasive bladder tumors (NMIBT) is transurethral resection of the bladder and BCG instillations. However, responses are limited, and new therapeutic alternatives for these patients are required. The results of checkpoint inhibitors in advanced tumors have led to interest in the use of these molecules in NMIBT. METHODS: We conducted a search on PubMed using the terms «bladder cancer¼ and «check point inhibitors¼. We have used the search engines clinicaltrials.gov and clinicaltrialsregister.eu for the search of clinical trials. RESULTS: There are currently 5 trials in progress on BCG untreated patients. There are no results available. As for BCG non-responders, there are 15 ongoing trials, two of them with preliminary results: Keynote 057, with promising results with pembrolizumab, which has led the FDA to approve its use in January 2020, and SWOG S1605, which has shown similar results with atezolizumab. Other trials are using intravesical administration of these drugs, which is an attractive option if it is effective for cancer control. CONCLUSIONS: Checkpoint inhibitors offer a new possibility for patients who do not respond to BCG. These will probably be used in the future for previously BCG untreated patients. Preliminary data from clinical trials show promising results. A good understanding of these molecules by urologists and the creation of multidisciplinary teams are crucial in order to offer the best therapeutic alternatives to these patients.

Evolución de las derivaciones desde Atención Primaria a Urología tras la creación de un grupo de trabajo y la instauración de protocolos y cursos de formación continuada / Analysis of referrals after a synergic work between primary care and urology. Impact of joint protocol implementation and a continuing education program in our healthcare area

Objetivo: Analizar la evolución y adecuación de las derivaciones de Atención Primaria a Urología tras la implantación de protocolos sobre las enfermedades urológicas más frecuentes y la instauración de un programa de formación continuada. Material y métodos: En el 2011 se creó un grupo de trabajo Atención Primaria-Urología. Se instauraron inicialmente protocolos de actuación y práctica clínica en enfermedad prostática (HBP y PSA), que se apoyaron con sesiones formativas a los médicos de Atención Primaria. Tras analizar su efecto, en el 2015 se añadieron otros 3(enfermedad escrotal, infecciones urinarias e incontinencia urinaria). Analizamos y comparamos las derivaciones y su adecuación antes y después de la instauración. Resultados: El motivo más frecuente de derivación son los síntomas del tracto urinario inferior (STUI) por HBP que, inicialmente, suponían un 22,8% del total, y que han disminuido al 16,9%. Tras la introducción de los demás algoritmos, observamos una disminución de las derivaciones sobre enfermedad escrotal (del 13-14 al 7,8%), que permanecen estables (en torno al 10%) las relacionadas con infecciones urinarias y que aumentan las derivaciones por incontinencia urinaria (del 3 al 10,3%). La adecuación a los protocolos fue mejorando progresivamente en las relacionadas con STUI (del 46 al 65,3%); en PSA (del 55 al 84,4%) y en incontinencia urinaria (del 66,2 al 73,1%). Descendió la adecuación en cuanto a enfermedad escrotal (del 67,1 al 63,3%) y se mantuvo similar en ITU (en torno al 76%). Conclusiones: El trabajo conjunto entre Urología y Atención Primaria consigue mejorar la adecuación de las derivaciones en las enfermedades urológicas más frecuentes

Objective: To analyse the evolution and adequacy of referrals from Primary Care to Urology, after the implementation of referral protocols on the most frequent urological diseases and the establishment of a continuing education program. Material and methods: A Primary Care-Urology work group was created in 2011. Initially, performance and clinical practice protocols in prostatic pathology (BPH and PSA) were established. These were supported by training sessions for primary care physicians. After analysing the effect of the mentioned joint work, 3more (scrotal pathology, urinary tract infections and urinary incontinence) were included. We analysed and compared the referrals and their adequacy before and after the establishment of the protocols. Results: The most common referral causes were symptoms of the lower urinary tract due to BPH, which initially represented 22.8% of the total, and decreased to 16.9%. After the introduction of the new algorithms, we observed a decrease in referrals for scrotal pathology (13-14% to 7.8%), an increase in urinary incontinence referrals (3% al 10.3%) and those related to urinary tract infections remained stable. The adequacy to the protocols improved progressively: LUTS from 46% to 65.3%; PSA from 55% to 84.4% and urinary incontinence from 66.2% to 73.1%. Adequacy in scrotal pathology decreased (de 67.1% a 63.3%), while in UTI it stayed much the same (around 76%). Conclusions: The joint work between Urology and Primary Care achieves an improvement in referrals adequacy regarding the most frequent urological pathologies

Analysis of referrals after a synergic work between Primary Care and Urology. Impact of joint protocol implementation and a continuing education program in our healthcare area. / Evolución de las derivaciones desde Atención Primaria a Urología tras la creación de un grupo de trabajo y la instauración de protocolos y cursos de formación continuada.

OBJECTIVE: To analyse the evolution and adequacy of referrals from Primary Care to Urology, after the implementation of referral protocols on the most frequent urological diseases and the establishment of a continuing education program. MATERIAL AND METHODS: A Primary Care-Urology work group was created in 2011. Initially, performance and clinical practice protocols in prostatic pathology (BPH and PSA) were established. These were supported by training sessions for primary care physicians. After analysing the effect of the mentioned joint work, 3more (scrotal pathology, urinary tract infections and urinary incontinence) were included. We analysed and compared the referrals and their adequacy before and after the establishment of the protocols. RESULTS: The most common referral causes were symptoms of the lower urinary tract due to BPH, which initially represented 22.8% of the total, and decreased to 16.9%. After the introduction of the new algorithms, we observed a decrease in referrals for scrotal pathology (13-14% to 7.8%), an increase in urinary incontinence referrals (3% al 10.3%) and those related to urinary tract infections remained stable. The adequacy to the protocols improved progressively: LUTS from 46% to 65.3%; PSA from 55% to 84.4% and urinary incontinence from 66.2% to 73.1%. Adequacy in scrotal pathology decreased (de 67.1% a 63.3%), while in UTI it stayed much the same (around 76%). CONCLUSIONS: The joint work between Urology and Primary Care achieves an improvement in referrals adequacy regarding the most frequent urological pathologies.

Tratamiento adyuvante intravesical en cáncer de vejiga no músculo invasivo: importancia de la cepa y el mantenimiento / Adjuvant intravesical treatment for nonmuscle invasive bladder cancer: The importance of the strain and maintenance

Introducción y objetivo: El bacilo de Calmette-Guérin (BCG) intravesical es clave en la prevención de recurrencia y progresión de tumor vesical superficial. El objetivo de nuestro trabajo es evaluar comparativamente la eficacia y toxicidad entre Connaught y Tice, así como la importancia del esquema de mantenimiento. Material y métodos: Revisamos retrospectivamente a 110 pacientes con tumor vesical superficial con tratamiento endovesical adyuvante, distribuidos en 3 grupos, según el tratamiento fuese con Connaught, Tice, o ambos secuencialmente. Se ha calculado la supervivencia libre de recidiva en cada grupo y también de los pacientes que completaron el mantenimiento frente a los que no lo hicieron. Para identificar factores predictores de recidiva se llevó a cabo un análisis multivariante. Además, se ha valorado la toxicidad analizando la aparición de becegeítis, urgencia miccional, fiebre, infección urinaria y abandono del tratamiento por los efectos secundarios. Resultados: No hallamos diferencias en los parámetros de eficacia. Los pacientes del grupo Connaught completaron en menor medida el mantenimiento (38,4 frente a 72% del grupo Tice y frente a 76,3% del grupo ambas; p = 0,010). Los pacientes que completaron el mantenimiento tuvieron mejor supervivencia libre de recidiva a 60 meses (88,5 vs. 74,2%; p = 0,036), independientemente de la cepa empleada. El análisis multivariante identificó como factores de riesgo de recidiva el tamaño mayor de 3 cm, más de 3 implantes y no completar el mantenimiento. Los pacientes de Connaught experimentan mayor tasa de becegeítis, sin diferencias en el resto de los eventos estudiados. Conclusión: Completar la fase de mantenimiento es esencial, independientemente de la cepa empleada. Connaught tiene más riesgo de becegeítis y un esquema secuencial puede ser útil en ciertos escenarios

Background and objective: Intravesical Bacille Calmette-Guérin (BCG) is essential for preventing the recurrence and progression of superficial bladder tumours. The aim of our study was to compare the efficacy and toxicity of the Connaught and Tice strains, as well as the importance of the maintenance regimen. Material and methods: We retrospectively reviewed 110 patients with superficial bladder tumours who underwent adjuvant endovesical treatment. The patients were distributed into 3 groups, based on whether the treatment was with the Connaught strain, the Tice strain or both sequentially. We calculated the relapse-free survival rate in each group and compared the patients who completed the maintenance treatments against those who did not. To identify the predictors of relapse, we performed a multivariate analysis. We also assessed the toxicity by analysing the onset of BCGitis, urinary urgency, fever, urinary tract infection and treatment withdrawing due to adverse effects. Results: We found no differences in the efficacy parameters. The patients in the Connaught group completed the maintenance to a lesser extent (38.4 vs. 72% for the Tice group and 76.3% for both groups; P=.010). The patients who completed the maintenance had better relapse-free survival at 60 months (88.5 vs. 74.2%; P=.036), regardless of the strain employed. The multivariate analysis identified a size larger than 3 cm, more than 3 implants and not completing the maintenance as risk factors of relapse. The patients with the Connaught strain had higher rates of BCGitis, with no differences in the other events studied. Conclusion: Completing the maintenance phase is essential, regardless of the strain employed. The Connaught strain has a greater risk of BCGitis, and a sequential regimen could be useful in certain scenarios

Adjuvant intravesical treatment for nonmuscle invasive bladder cancer: The importance of the strain and maintenance. / Tratamiento adyuvante intravesical en cáncer de vejiga no músculo invasivo: importancia de la cepa y el mantenimiento.

BACKGROUND AND OBJECTIVE: Intravesical Bacille Calmette-Guérin (BCG) is essential for preventing the recurrence and progression of superficial bladder tumours. The aim of our study was to compare the efficacy and toxicity of the Connaught and Tice strains, as well as the importance of the maintenance regimen. MATERIAL AND METHODS: We retrospectively reviewed 110 patients with superficial bladder tumours who underwent adjuvant endovesical treatment. The patients were distributed into 3 groups, based on whether the treatment was with the Connaught strain, the Tice strain or both sequentially. We calculated the relapse-free survival rate in each group and compared the patients who completed the maintenance treatments against those who did not. To identify the predictors of relapse, we performed a multivariate analysis. We also assessed the toxicity by analysing the onset of BCGitis, urinary urgency, fever, urinary tract infection and treatment withdrawing due to adverse effects. RESULTS: We found no differences in the efficacy parameters. The patients in the Connaught group completed the maintenance to a lesser extent (38.4 vs. 72% for the Tice group and 76.3% for both groups; P=.010). The patients who completed the maintenance had better relapse-free survival at 60 months (88.5 vs. 74.2%; P=.036), regardless of the strain employed. The multivariate analysis identified a size larger than 3cm, more than 3 implants and not completing the maintenance as risk factors of relapse. The patients with the Connaught strain had higher rates of BCGitis, with no differences in the other events studied. CONCLUSION: Completing the maintenance phase is essential, regardless of the strain employed. The Connaught strain has a greater risk of BCGitis, and a sequential regimen could be useful in certain scenarios.

Evolución de las derivaciones de atención primaria a urología. Impacto de un protocolo en enfermedad prostática y de formación continuada / Evolution of primary care referrals to urology. Impact of a protocol on prostate disease and continuing education

Objetivo: Analizar la evolución de las derivaciones desde atención primaria (AP) a urología tras implantar un protocolo conjunto en enfermedad prostática y un programa de formación continuada en nuestra área sanitaria. Material y métodos: En enero de 2011 iniciamos un protocolo de actuación en enfermedad prostática, que se complementó con sesiones formativas y con un sistema de consultas vía correo electrónico. Analizamos las derivaciones desde AP a urología entre 2011 y 2013, determinando el motivo de consulta y la adecuación a los criterios establecidos en enfermedad prostática. Obtuvimos los datos del programa «Solicitud de cita en atención especializada» de la Comunidad de Madrid. Calculamos el tamaño muestral con un nivel de confianza del 95% y heterogeneidad del 50%. Resultados: Se produjeron 19.048 derivaciones. El motivo de consulta más frecuente fue STUI asociado a HBP, con una reducción del 27% y una adecuación que pasó del 46 al 67%. Las consultas por PSA, aunque aumentaron un 40%, también mejoraron su adecuación (del 55 al 72%), siendo la principal consulta por sospecha de malignidad (30%). Destacan además la incontinencia femenina, que ha duplicado su número, y el descenso del 41% en disfunción eréctil, que pueden justificarse por la formación impartida a AP. Conclusiones: La colaboración entre urología y AP consigue mejorar la adecuación de las derivaciones en enfermedad prostática y modificar la tendencia de derivación del resto de enfermedades incluidas en el proyecto

Objective: To analyze the evolution of primary care referrals to the Urology Department after the implementation of a joint protocol on prostate disease and a continuing education program in our healthcare area. Material and methods: In January 2011, we launched an action protocol on prostate disease, which was complemented by training sessions and an e-mail-based consultation system. We analyzed primary care referrals to the Urology Department between 2011 and 2013 and determined the reasons for the consultations and the compliance with the established criteria on prostate disease. We obtained data from the "Request for Appointment in Specialized Care" program of the Community of Madrid. We calculated the sample size with a 95% confidence level and a 50% heterogeneity. Results: A total of 19,048 referrals were conducted. The most common reason for the referrals was lower urinary tract symptoms associated with benign prostate hyperplasia, with a 27% reduction and a compliance that went from 46% at 67%. Although prostate-specific antigen consultations increased by 40%, they improved their appropriateness (from 55% to 72%). This was the main type of consultation for suspicion of malignancy (30%). Also worth mentioning were female incontinence, which doubled in number, and a 41% reduction in erectile dysfunction, which could be due to the primary care training. Conclusions: The collaboration between the Department of Urology and primary care succeeded in improving the appropriateness of prostate disease referrals and modified the tendency to refer the rest of the diseases included in the project

Infecciones urinarias adquiridas en la comunidad que requieren hospitalización: factores de riesgo, características microbiológicas y resistencia a antibióticos / Community-associated urinary infections requiring hospitalization: Risk factors, microbiological characteristics and patterns of antibiotic resistance

Objetivo: Las infecciones del tracto urinario (ITU) suelen manejarse ambulatoriamente. Sin embargo, un pequeño porcentaje requiere ingreso hospitalario. Nuestro objetivo fue analizar los factores de riesgo y características microbiológicas de las infecciones urinarias adquiridas en la comunidad (ITU-AC) que requieren hospitalización. Material y métodos: Realizamos un estudio prospectivo desde noviembre de 2011 a diciembre de 2013 evaluando la incidencia, factores de riesgo, patrones microbiológicos y tasas de resistencia en los pacientes con ITU-AC que requieren ingreso. Resultados: Cuatrocientos cincuenta y siete pacientes ingresaron en nuestro servicio con diagnóstico de ITU-AC. La edad media fue 56,2 ± 19,85 años, el 52,1% eran mujeres, el 19,7% portaban catéter urinario y el 11,4% habían presentado ITU en los meses previos. Los microorganismos más frecuentemente aislados fueron Escherichia coli (60,6%), Klebsiella (9,2%), Enterococcus (8,4%) y Pseudomonas (7,2%). Enterobacteriaceae diferentes a E. coli fueron más frecuentes en pacientes de mayor edad. Enterococcus fueron más frecuentemente aislados en pacientes que habían tenido ITU previa y en aquellos portadores de catéter urinario. E. coli mostró unas resistencias del 23,5% para amoxicilina/ácido clavulánico, 16,6% para cefalosporinas de tercera generación, 31,3% para quinolonas y16,7% para aminoglucósidos. Del total de E. coli 11,4% fueron productores de betalactamasas de espectro extendido (BLEE). Los Enterococcus y Pseudomonas mostraron resistencias a quinolonas del 50,0% y 61,5% respectivamente. Conclusiones: ITU-AC que requieren hospitalización se presentan más frecuentemente en varones de mayor edad, portadores de catéter urinario, litiasis urinaria y con episodios previos de ITU. Estos factores también se asocian con infecciones producidas por gérmenes diferentes a E. coli y altas tasas de resistencia

Objective: Although patients with urinary tract infections (UTIs) are usually managed as outpatients, a percentage of them requires hospitalization. To review risk factors and microbiological characteristics of community-associated UTIs (CAUTIs) requiring hospitalization has been our objective. Material and methods: A prospective observational study was carried out from November 2011 to December 2013. Incidence, microbiological characteristics and antibiotic resistance patterns in patients with CAUTIs that required hospitalization were analyzed. Risk factors (including diabetes mellitus, urolithiasis, urinary catheterization) and resistance rates of each pathogen were also analyzed. Results: Four hundred and fifty seven patients were hospitalized in our department with CAUTI. The mean age was 56.2 ± 19.85 years. Of them, 52.1% patients were women, 19.7% had urinary indwelling catheter and 11.4% have had a previous UTI. The most frequently isolated pathogens were Escherichia coli (60.6%), followed by Klebsiella (9.2%), Enterococcus (8.4%) and Pseudomonas (7.2%). Enterobacteriaceae other than E.coli were more prevalent in male and older patients. On the other side the most frequently isolated pathogen in patients with a previous UTI and a urinary catheter was Entercoccus. The resistance rates E. coli against ampicillin/amoxicillin + βlactamase inhibitor was 23.5%, against third-generation cephalosporins 16.6%, against fluoroquinolones 31.3% and 16.7% against aminoglycosides. 11.4% E. coli strains were producers of extended-spectrum Beta-lactamases (ESBL). Finally, the resistance rates of Enterococcus and Pseudomonas against quinolones were of 50.0% and 61.5%, respectively. Conclusions: CAUTIs that require hospitalization are most frequent in older age, male gender, and presence of urinary catheter, with urolithiasis and with previous episodes of UTI. These factors are also related to isolation of pathogens other than E. coli and higher resistance rates

Evolution of primary care referrals to urology. Impact of a protocol on prostate disease and continuing education.

OBJECTIVE: To analyze the evolution of primary care referrals to the Urology Department after the implementation of a joint protocol on prostate disease and a continuing education program in our healthcare area. MATERIAL AND METHODS: In January 2011, we launched an action protocol on prostate disease, which was complemented by training sessions and an e-mail-based consultation system. We analyzed primary care referrals to the Urology Department between 2011 and 2013 and determined the reasons for the consultations and the compliance with the established criteria on prostate disease. We obtained data from the "Request for Appointment in Specialized Care" program of the Community of Madrid. We calculated the sample size with a 95% confidence level and a 50% heterogeneity. RESULTS: A total of 19,048 referrals were conducted. The most common reason for the referrals was lower urinary tract symptoms associated with benign prostate hyperplasia, with a 27% reduction and a compliance that went from 46% at 67%. Although prostate-specific antigen consultations increased by 40%, they improved their appropriateness (from 55% to 72%). This was the main type of consultation for suspicion of malignancy (30%). Also worth mentioning were female incontinence, which doubled in number, and a 41% reduction in erectile dysfunction, which could be due to the primary care training. CONCLUSIONS: The collaboration between the Department of Urology and primary care succeeded in improving the appropriateness of prostate disease referrals and modified the tendency to refer the rest of the diseases included in the project.

Community-associated urinary infections requiring hospitalization: risk factors, microbiological characteristics and patterns of antibiotic resistance.

OBJECTIVE: Although patients with urinary tract infections (UTIs) are usually managed as outpatients, a percentage of them requires hospitalization. To review risk factors and microbiological characteristics of community-associated UTIs (CAUTIs) requiring hospitalization has been our objective. MATERIAL AND METHODS: A prospective observational study was carried out from November 2011 to December 2013. Incidence, microbiological characteristics and antibiotic resistance patterns in patients with CAUTIs that required hospitalization were analyzed. Risk factors (including diabetes mellitus, urolithiasis, urinary catheterization) and resistance rates of each pathogen were also analyzed. RESULTS: Four hundred and fifty seven patients were hospitalized in our department with CAUTI. The mean age was 56.2±19.85 years. Of them, 52.1% patients were women, 19.7% had urinary indwelling catheter and 11.4% have had a previous UTI. The most frequently isolated pathogens were Escherichia coli (60.6%), followed by Klebsiella (9.2%), Enterococcus (8.4%) and Pseudomonas (7.2%). Enterobacteriaceae other than E.coli were more prevalent in male and older patients. On the other side the most frequently isolated pathogen in patients with a previous UTI and a urinary catheter was Entercoccus. The resistance rates E. coli against ampicillin/amoxicillin + ß lactamase inhibitor was 23.5%, against third-generation cephalosporins 16.6%, against fluoroquinolones 31.3% and 16.7% against aminoglycosides. 11.4% E. coli strains were producers of extended-spectrum Beta-lactamases (ESBL). Finally, the resistance rates of Enterococcus and Pseudomonas against quinolones were of 50.0% and 61.5%, respectively. CONCLUSIONS: CAUTIs that require hospitalization are most frequent in older age, male gender, and presence of urinary catheter, with urolithiasis and with previous episodes of UTI. These factors are also related to isolation of pathogens other than E. coli and higher resistance rates.

Estudio de seguridad de la biopsia renal percutánea con aguja de calibre 16 G / Renal biopsy with 16 G needle: A safety study

Introducción y objetivo: Recientemente se vuelve a discutir sobre la implantación de la biopsia renal percutánea como procedimiento rutinario en el diagnóstico de masas renales. Sin embargo, aunque infrecuentes, esta técnica no está exenta de complicaciones y morbilidad. Nuestro objetivo es realizar un estudio descriptivo de las complicaciones y resultados de las biopsias renales ortotópicas con aguja de 16 G. Material y métodos: Llevamos a cabo una revisión retrospectiva de 180 biopsias renales ortotópicas ecodirigidas realizadas en nuestro servicio entre enero de 2008 y mayo de 2010. La técnica se realiza utilizando una aguja de diámetro 16 G acoplada a una pistola automática. Se recogen múltiples variables clínicas, así como las complicaciones tempranas derivadas del procedimiento y la actitud adoptada respecto a ellas. Se estudió la tasa de complicaciones, así como la relación entre factores de riesgo y aparición de complicaciones. Resultados: La edad media fue de 55,8 años, obteniéndose una media de 2,49 cilindros por intervención. La tasa global de complicaciones fue del 5,6%. Únicamente en 3 (1,67%) pacientes de los 180 fue necesaria una actitud intervencionista derivada de complicación del procedimiento. No hubo necesidad de intervenciones quirúrgicas ni se produjeron fallecimientos derivados del procedimiento. No se demostró relación entre HTA (p = 0,09), anticoagulación previa (p = 0,099) o antiagregación previa (p = 0,603) y complicaciones. El 2,8% de las biopsias presentaron material insuficiente para el diagnóstico. Conclusiones: La biopsia renal percutánea ecodirigida con aguja de 16 G es una técnica segura y con una rentabilidad diagnóstica elevada

Introduction and objective: The development of percutaneous renal biopsy as a routinary diagnostic procedure for renal masses is topic of discussion for the last few years. However, this technique has been associated with some complications, although infrequent, and morbidity. Our objective is to carry out a descriptive study about complications and outcomes of orthotopic kidney biopsies with 16 G needle. Material and methods: A retrospective review of 180 orthotopic ultrasound-guided renal biopsies performed in our service among January 2008 to May 2010 was carried out. The procedure was developed using an automated biopsy gun (16G needle). Multiple clinical variables, early post-procedure complications and its management were collected. Complication rates as well as the relationship between risk factors and occurrence of complications were studied. Results: Mean age was 55.8 years. The average number of biopsy cylinders per intervention was 2.49. The overall complication rate was 5.6%. An interventionist attitude derived from complication of the procedure was necessary in only 3 patients (1.67%). No surgical interventions were required and no death as consequence of procedure was registered. No relationship between hypertension (P = .09) previous anticoagulation (P = .099) or previous antiaggregation (P = .603) and complications were demonstrated. In 2.8% of biopsies the material obtained was insufficient for diagnosing. Conclusions: Percutaneous ultrasound-guided renal biopsy with 16G needle is a safe technique with high diagnostic performance