Resultados de la rama española del Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC). Actualización tras 21 años de seguimiento / Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up

INTRODUCCIÓN Y OBJETIVO: El Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC) tiene como objetivo probar si el cribado del cáncer de próstata (CaP) reduce la mortalidad por esta enfermedad. Este estudio multicéntrico (ocho países europeos) ha reclutado más de 180.000 varones asintomáticos. Tras un tiempo de seguimiento de 16 años se ha demostrado que el cribado con PSA reduce la mortalidad por CaP un 20%, sin efecto sobre la mortalidad global (por cualquier causa). En este artículo se ofrece una actualización de los resultados de la rama española del ERSPC tras 21 años de seguimiento. MATERIALES Y MÉTODOS: Como centro participante en el ERSPC se invitó a participar en el estudio a 18.612 varones entre los 45 y 70 años de edad de los municipios de Getafe y Parla (Madrid). Randomización en brazo intervención (determinación de PSA sérico), y en brazo control (seguimiento sin realizar pruebas). Se registraron los diagnósticos de CaP, así como la mortalidad por CaP y por todas las causas, realizando comparación entre ambos brazos del estudio de las curvas de supervivencia, y análisis pormenorizado de las causas de muerte. RESULTADOS: El estudio se llevó a cabo finalmente con 4.276 varones (2.415 brazo intervención, 1.861 brazo control). Las medianas de edad, PSA sérico y tiempo de seguimiento fueron 57 años, 0,9 ng/ml y 21,1 años respectivamente. Se diagnosticaron 285 CaP, 188 (7,8%) brazo intervención, 97 (5,2%) brazo control (p < 0,001). Un total de 216 (75,8%) debutaron en estadio clínico organoconfinado. Se registraron 994 fallecimientos, 544 (22,5%) en el brazo intervención y 450 (24,2%) en el brazo control. No se detectaron diferencias significativas entre los brazos del estudio en términos de mortalidad cáncer-específica (p = 0,768) o por todas las causas (p = 0,192). La principal causa de muerte fueron los tumores malignos (492 pacientes, 49,5% del total de muertes), siendo los sitios primarios más frecuentes pulmón y bronquios (29,5%), colon y recto (14,8%), y hematológicos (9,8%). Solo 20 pacientes (0,4% de los varones reclutados) fallecieron por CaP, sin diferencia significativa entre brazos del estudio. CONCLUSIONES: En esta actualización de los resultados de la rama española del estudio ERSPC tras 21 años de seguimiento, no hemos detectado un beneficio del cribado del CaP en términos de supervivencia global, ni cáncer específica

INTRODUCTION AND OBJECTIVE: The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up. MATERIALS AND METHODS: The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed. RESULTS: The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p < ,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p = .768) or all-cause (p = .192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms. CONCLUSIONS: In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival

Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up. / Resultados de la rama española del Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC). Actualización tras 21 años de seguimiento.

INTRODUCTION AND OBJECTIVE: The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up. MATERIALS AND METHODS: The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed. RESULTS: The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p<,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms. CONCLUSIONS: In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival.

Factores predictivos de recidiva de estenosis uretral tras uretrotomía endoscópica / Predictors of urethral stricture recurrence after endoscopic urethrotomy

Objetivo: El objetivo del trabajo fue analizar las variables clínico-demográficas de la serie y los factores predictores de recidiva de estenosis uretral tras uretrotomía endoscópica. Material y métodos: Se analizó retrospectivamente a 67 pacientes tratados mediante uretrotomía endoscópica tipo Sachse entre junio de 2006 y septiembre de 2014. Se excluyó a los intervenidos previamente de uretrotomía endoscópica o uretroplastia y se incluyó al resto de los pacientes que presentaban estenosis uretral. Se analizó edad, peso, hábito tabáquico, factores de riesgo cardiovascular, número, localización, longitud y etiología de la estenosis, uretrotomía previa, tiempo de sonda vesical y dilataciones posquirúrgicas. Se realizó un análisis univariado y multivariado mediante el test de chi-cuadrado o de Fisher y regresión logística para identificar las variables relacionadas con la recidiva. Resultados: El 37% recidivaron. La mayoría eran > 60 años (56,7%), obesos (74,6%), no fumadores (88%) y sin factores cardiovasculares (56,7%). La mayoría de las estenosis fueron únicas (94%), < 1 cm (82%), de uretra bulbar (64,2%), iatrogénicas (67,2%) y sin uretrotomía previa (89,6%). La mayoría llevaron sonda vesical durante < 15 días (85,1%) y no realizaron dilataciones posquirúrgicas (65,7%). Solamente la longitud de la estenosis resultó factor de riesgo independiente de recidiva (p = 0,025) con un riesgo relativo de 5,7 para un IC 95% (1,21-26,41). Conclusiones: En el tratamiento de la estenosis uretral mediante uretrotomía endoscópica, la longitud de la estenosis > 1 cm es el único factor que predice un incremento del riesgo de recidiva. No se encontró factores clínicos ni demográficos que condicionaran un incremento en la incidencia de recidiva. Del mismo modo, factores técnicos como incrementar el tiempo de sondaje vesical o las dilataciones uretrales no alteran el curso de la enfermedad, por lo que su uso rutinario es innecesario

Objective: The aim of the study was to analyse the clinical-demographic variables of the series and the predictors of urethral stricture recurrence after endoscopic urethrotomy. Material and methods: We retrospectively analysed 67 patients who underwent Sachse endoscopic urethrotomy between June 2006 and September 2014. Those patients who had previously undergone endoscopic urethrotomy or urethroplasty were excluded. The other patients who presented urethral stricture were included. We analysed age, weight, smoking habit, and cardiovascular risk factors, as well as the number, location, length and aetiology of the strictures, previous urethrotomies, vesical catheter duration and postsurgical dilatations. A univariate and multivariate analysis was conducted using the chi-squared test or Fisher's test and logistic regression to identify the variables related to recurrence. Results: Thirty-seven percent of the patients had a relapse. The majority of the patients were older than 60 years (56.7%), obese (74.6%), nonsmokers (88%) and had no cardiovascular factors (56.7%). The majority of the strictures were single (94%), < 1 cm (82%), bulbar urethral (64.2%), iatrogenic (67.2%) and with no prior urethrotomy (89.6%). The majority of the patients carried a vesical catheter for < 15 days (85.1%) and did not undergo postsurgical dilatation (65.7%). Only the length of the stricture was an independent risk factor for recurrence (P = .025; relative risk, 5.7; 95% CI 1.21-26.41). Conclusions: In the treatment of urethral strictures through endoscopic urethrotomy, a stricture length > 1 cm is the only factor that predicts an increase in the risk of recurrence. We found no clinical or demographic factors that caused an increase in the incidence of recurrence. Similarly, technical factors such as increasing the bladder catheterisation time and urethral dilatations did not change the course of the disease. Their routine use is therefore unnecessary

Cavernoplastia con injerto de mucosa oral para el tratamiento quirúrgico de la enfermedad de La Peyronie / Cavernoplasty with oral mucosa graft for the surgical treatment of Peyronie's disease

Introducción: La enfermedad de La Peyronie es un trastorno de la albugínea que condiciona incurvación peneana, y que precisa corrección quirúrgica cuando la deformidad dificulta la penetración. Material y métodos: Análisis retrospectivo de los resultados a corto plazo (longitud del pene, ángulo de incurvación y función eréctil) del tratamiento de la enfermedad de La Peyronie en 10 pacientes mediante cavernoplastia con injerto de mucosa oral. En esencia, el tratamiento incluyó la incisión de la placa fibrótica con bisturí eléctrico y el posterior recubrimiento del defecto cavernoso mediante un parche de mucosa oral. Al sexto mes medimos la longitud e incurvación peneanas, y recogimos la función eréctil mediante el cuestionario IIEF-5. Finalmente, se planteó a los pacientes la pregunta «¿volvería a repetir la misma intervención?». Resultados: La edad media fue de 53,4 años. El seguimiento promedio fue de 22,7 meses y la mediana de 24. La incurvación media preoperatoria fue de 68,5° (50-90°); la longitud media del pene de 11,2 cm (9-15) y el IIEF-5 medio de 16,1 (8-25). La longitud peneana media postoperatoria fue de 10,7 cm y el IIEF-5 medio de 18,9. Las diferencias entre los registros pre- y postoperatorios no alcanzaron significación estadística (p = ns). Un paciente desarrolló disfunción eréctil. En todos los casos la incurvación residual fue < 20°. Nueve pacientes (90%) aseguraron que repetirían la misma intervención. Conclusiones: Los resultados a corto plazo señalan que la cavernoplastia con injerto de mucosa oral puede ser una alternativa a los injertos tradicionales para la corrección quirúrgica de la enfermedad de La Peyronie

Background: Peyronie's disease is a disorder of the tunica albuginea and causes penile curvature, requiring surgical correction when the deformity impedes penetration. Material and methods: Retrospective analysis of the short-term results (penile length, angle of curvature and erectile function) of treating Peyronie's disease in 10 patients through cavernoplasty with oral mucosa graft. Essentially, the treatment included the incision of the fibrotic plaque with electrical scalpel and the subsequent coating of the cavernous defect using a patch of oral mucosa. At month 6, we measured the penile length and curvature and recorded the erectile function using the International Index of Erectile Function-5 (IIEF-5) questionnaire. Finally, the patients were asked 'Would you undergo the same operation again?'. Results: The mean age was 53.4 years. The average and median follow-up was 22.7 months and 24 months, respectively. The mean preoperative curvature was 68.5° (50°-90°), the mean penile length was 11.2 cm (9-15) and the mean IIEF-5 score was 16.1 (8-25). The mean postoperative penile length was 10.7 cm, and the mean IIEF-5 score was 18.9. The differences between the preoperative and postoperative values were not statistically significant (P=ns). One patient developed erectile dysfunction. In all cases, the residual curvature was <20°. Nine patients (90%) stated that they would undergo the same operation. Conclusions: The short-term results suggest that cavernoplasty with oral mucosa graft can be an alternative to traditional grafts for surgically correcting Peyronie's disease

Predictors of urethral stricture recurrence after endoscopic urethrotomy. / Factores predictivos de recidiva de estenosis uretral tras uretrotomía endoscópica.

OBJECTIVE: The aim of the study was to analyse the clinical-demographic variables of the series and the predictors of urethral stricture recurrence after endoscopic urethrotomy. MATERIAL AND METHODS: We retrospectively analysed 67 patients who underwent Sachse endoscopic urethrotomy between June 2006 and September 2014. Those patients who had previously undergone endoscopic urethrotomy or urethroplasty were excluded. The other patients who presented urethral stricture were included. We analysed age, weight, smoking habit, and cardiovascular risk factors, as well as the number, location, length and aetiology of the strictures, previous urethrotomies, vesical catheter duration and postsurgical dilatations. A univariate and multivariate analysis was conducted using the chi-squared test or Fisher's test and logistic regression to identify the variables related to recurrence. RESULTS: Thirty-seven percent of the patients had a relapse. The majority of the patients were older than 60 years (56.7%), obese (74.6%), nonsmokers (88%) and had no cardiovascular factors (56.7%). The majority of the strictures were single (94%), <1cm (82%), bulbar urethral (64.2%), iatrogenic (67.2%) and with no prior urethrotomy (89.6%). The majority of the patients carried a vesical catheter for <15 days (85.1%) and did not undergo postsurgical dilatation (65.7%). Only the length of the stricture was an independent risk factor for recurrence (P=.025; relative risk, 5.7; 95% CI 1.21-26.41). CONCLUSIONS: In the treatment of urethral strictures through endoscopic urethrotomy, a stricture length >1cm is the only factor that predicts an increase in the risk of recurrence. We found no clinical or demographic factors that caused an increase in the incidence of recurrence. Similarly, technical factors such as increasing the bladder catheterisation time and urethral dilatations did not change the course of the disease. Their routine use is therefore unnecessary.

Cavernoplasty with oral mucosa graft for the surgical treatment of Peyronie's disease. / Cavernoplastia con injerto de mucosa oral para el tratamiento quirúrgico de la enfermedad de La Peyronie.

BACKGROUND: Peyronie's disease is a disorder of the tunica albuginea and causes penile curvature, requiring surgical correction when the deformity impedes penetration. MATERIAL AND METHODS: Retrospective analysis of the short-term results (penile length, angle of curvature and erectile function) of treating Peyronie's disease in 10 patients through cavernoplasty with oral mucosa graft. Essentially, the treatment included the incision of the fibrotic plaque with electrical scalpel and the subsequent coating of the cavernous defect using a patch of oral mucosa. At month 6, we measured the penile length and curvature and recorded the erectile function using the International Index of Erectile Function-5 (IIEF-5) questionnaire. Finally, the patients were asked "Would you undergo the same operation again?". RESULTS: The mean age was 53.4 years. The average and median follow-up was 22.7 months and 24 months, respectively. The mean preoperative curvature was 68.5° (50°-90°), the mean penile length was 11.2cm (9-15) and the mean IIEF-5 score was 16.1 (8-25). The mean postoperative penile length was 10.7cm, and the mean IIEF-5 score was 18.9. The differences between the preoperative and postoperative values were not statistically significant (P=ns). One patient developed erectile dysfunction. In all cases, the residual curvature was <20°. Nine patients (90%) stated that they would undergo the same operation. CONCLUSIONS: The short-term results suggest that cavernoplasty with oral mucosa graft can be an alternative to traditional grafts for surgically correcting Peyronie's disease.

Rotación de los cuerpos cavernosos para el tratamiento de la incurvación peneana congénita / Rotation of the corpora cavernosa for the treatment of congenital penile curvature

Introducción: La incurvación peneana congénita (IPC) está originada por una alteración en el desarrollo embrionario de la uretra y los cuerpos cavernosos. Condiciona dificultad para la penetración, precisando corrección quirúrgica cuando imposibilita el coito. Material y métodos: Presentamos 2 varones en la 4.ª década de la vida que presentan incurvación ventral superior a 60° de 2 años de evolución con erecciones mantenidas. Los pacientes fueron sometidos a cirugía de rotación de los cuerpos cavernosos. Tras la denudación completa del pene se realiza la liberación atérmica del paquete vasculonorvioso del pene desde la cara ventral hasta la dorsal. Una vez evidenciada la incurvación mediante una erección artificial se realiza una incisión en la albugínea de ambos cuerpos cavernosos, suturando de forma continua con monofilamento reabsorbible ambos bordes internos y externos. Posteriormente se comprueba la rectificación de la incurvación y se reconstruye el plano mucocutáneo. Resultados: El tiempo quirúrgico fue de 120 min, no existiendo complicaciones intraoperatorias. Ambos pacientes fueron dados de alta a las 24 h de la intervención. A la semana presentaban erecciones nocturnas espontáneas, pudiendo mantener relaciones sexuales al mes de la intervención. A los 6 meses la incurvación residual era inferior a 20°, el acortamiento peneano inferior al centímetro y el IIEF-5 de 25 en ambos casos. Conclusiones: La cirugía de rotación de los cuerpos cavernosos permite corregir la IPC sin acortamiento peneano significativo ni disfunción eréctil. En nuestra opinión constituye un tratamiento adecuado en pacientes con IPC, necesitándose estudios con seguimientos a largo plazo para considerarla la técnica de elección

Introduction: Congenital penile curvature (CPC) is caused by a disorder in the embryonic development of the urethra and corpora cavernosa. The condition causes difficulty for penetration, requiring surgical correction when it prevents intercourse. Material and methods: We present the cases of 2 men in their 40s who had ventral curvature greater than 60° of 2 years of evolution, with maintained erections. The patients underwent surgery for rotation of the corpora cavernosa. After the complete denudation of the penis, athermal release of the neurovascular bundle of the penis from the ventral side to the dorsal was performed. Once the curvature was verified using artificial erection, an incision was performed in the tunica albuginea of both corpora cavernosa, continuously suturing both internal and external margins with resorbable monofilament. The rectification of the curvature was then checked, and the mucocutaneous plane was reconstructed. Results: The surgical time was 120 minutes and there were no intraoperative complications. Both patients were discharged 24 h after the surgery. At 1 week, the patients experienced spontaneous night-time erections and were able to maintain sexual relations 1 month after the surgery. At 6 months, the residual curvature was less than 20°, the penile shortening was less than 1 centimeter and the International Index of Erectile Function-5 was 25 for both cases. Conclusions: Surgery for rotation of the corpora cavernosa helps correct CPC without significant penile shortening or erectile dysfunction. In our opinion, the procedure is an appropriate treatment for patients with CPC but requires studies with long-term follow-up in order to consider it the technique of choice

Rotation of the corpora cavernosa for the treatment of congenital penile curvature.

INTRODUCTION: Congenital penile curvature (CPC) is caused by a disorder in the embryonic development of the urethra and corpora cavernosa. The condition causes difficulty for penetration, requiring surgical correction when it prevents intercourse. MATERIAL AND METHODS: We present the cases of 2 men in their 40s who had ventral curvature greater than 60° of 2 years of evolution, with maintained erections. The patients underwent surgery for rotation of the corpora cavernosa. After the complete denudation of the penis, athermal release of the neurovascular bundle of the penis from the ventral side to the dorsal was performed. Once the curvature was verified using artificial erection, an incision was performed in the tunica albuginea of both corpora cavernosa, continuously suturing both internal and external margins with resorbable monofilament. The rectification of the curvature was then checked, and the mucocutaneous plane was reconstructed. RESULTS: The surgical time was 120minutes and there were no intraoperative complications. Both patients were discharged 24h after the surgery. At 1 week, the patients experienced spontaneous night-time erections and were able to maintain sexual relations 1 month after the surgery. At 6 months, the residual curvature was less than 20°, the penile shortening was less than 1 centimeter and the International Index of Erectile Function-5 was 25 for both cases. CONCLUSIONS: Surgery for rotation of the corpora cavernosa helps correct CPC without significant penile shortening or erectile dysfunction. In our opinion, the procedure is an appropriate treatment for patients with CPC but requires studies with long-term follow-up in order to consider it the technique of choice.

Reanastomosis uretro vesical por extraccion accidental de sonda vesical tras prostatectomia radical / Urethrovesical redo anastomosis after accidental removal of the urethral catheter after radical prostatectomy

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Predicting factors for recurrence in low-grade Ta primary bladder tumours.

OBJECTIVES: Ta bladder tumors constitute 53% of primary bladder neoplasms, 70% of them being low-grade (G1). These tumors present a 15- 38% chance of recurrence during the first year. The aim of this paper is to identify the predicting factors of the first recurrence in a series of TaG1 primary bladder tumors. METHODS: We have retrospectively analyzed patients who were diagnosed with TaG1 primary bladder tumor by transurethral resection between 2004 and 2012. We established their tumor grade and pathological stage according to the WHO's classification guides for 1973 and 2004 as well as 2009's TNM. Those patients who were diagnosed before 2009 did not receive any adjuvant treatment. Those who were diagnosed later on received 40 mg of endovesical Mitomycin C during their immediate post operative period as their only treatment. We define recurrence as the presence of tumor after the first cystoscopy and relapse-free survival (RFS) as the period of time (in months) until the first recurrence appeared. Follow up constitutes the period of time (in months) until the last check-up or first recurrence. We also analyzed different variables: age, gender, smoking habits, muscular representation in the sample, size of the tumor (> or < 1 cm), multiple or single tumors and adjuvant treatment. The survival analysis was performed by the Kaplan-Meier method, using the long-rank test to evaluate the differences between groups. RESULTS: 68 patients were included in the study (73.5% men, 75% smokers). The average age was 61.9 years (the median being 58.5). Average follow up was 33.2 months (median 28.4). 35.3% of patients experienced recurrence. Average RFS was 19.2 ± 12.7 months (median 13.5). The majority of tumors were of a single nature (77.9%), with a size of less than 1 cm (55.9%) and with muscle representation (52.9%). 57.4% of patients did not receive adjuvant treatment. Only the absence of adjuvant treatment was associated with recurrence in uni and multivariate analysis (p<0,001), with a relative risk of 17,5 IC95% (7,6-30,2). CONCLUSION: The absence of adjuvant therapy with Mitomycin C is the only factor that, in a statistically significant way, increases the risk of recurrence, regardless of demographic factors and the characteristics of the tumor.

Factores predictores de recidiva en el tumor vesical primario Ta de bajo grado / Predicting factors for recurrence in low-grade Ta primary bladder tumours

OBJETIVO: Los tumores vesicales Ta constituyen el 53% de las neoplasias primarias de la vejiga, siendo el 70% de bajo grado (G1), presentando una probabilidad de recurrencia al primer año del 15-38%. El objetivo de nuestro trabajo es identificar los factores predictivos de primera recidiva de nuestra serie de tumores vesicales primarios TaG1. MÉTODOS: Analizamos retrospectivamente los pacientes diagnosticados mediante RTU de tumor vesical primario TaG1 entre 2004 y 2012. Los pacientes diagnosticados antes de 2009 no recibieron tratamiento adyuvante. Los diagnosticados posteriormente recibieron 40 mg de Mitomicina C endovesical en el postoperatorio inmediato como único tratamiento. Definimos como recidiva la presencia de tumor después de la primera cistoscopia. Definimos como supervivencia libre de recidiva (SLR) el tiempo en meses hasta la primera recidiva y como tiempo de seguimiento el tiempo en meses hasta la última revisión o primera recidiva. Analizamos las variables: edad, sexo, tabaquismo, representación muscular en la muestra, tamaño tumoral (> o < 1 cm), tumor único o múltiple y tratamiento adyuvante. Realizamos un análisis univariado y multivariado mediante chi-cuadrado y regresión logística para identificar las variables relacionadas con la recidiva. Realizamos un análisis de supervivencia mediante el método de Kaplan-Meier, utilizando el test Log-Rank para evaluar las diferencias entre los grupos. RESULTADOS: Incluimos 68 pacientes (73,5% varones, 75% fumadores). La edad media fue 61,9 años (mediana 58,5). El seguimiento medio fue 33,2 meses (mediana 28,4). El 35,3% de los pacientes recidivaron. La SLR media fue 19,2±12,7 meses (mediana 13,5). La densidad de incidencia de recidiva fue 13,5 recidivas /100 casos/año. Mayoritariamente los tumores fueron únicos (77,9%), <1 cm (55,9%) y con representación muscular (52,9%). El 57,4% de los pacientes no recibieron adyuvancia. Solamente la ausencia de tratamiento adyuvante se asoció con la recidiva en los análisis uni y multivariado (p<0,001), con un riesgo relativo de 17,5 IC95% (7,6-30,2). CONCLUSIONES: La ausencia de adyuvancia con Mitomicina C es el único factor que incrementa de forma estadísticamente significativa el riesgo de recidiva, independientemente de los factores demográficos y características tumorales

OBJECTIVES: Ta bladder tumors constitute 53% of primary bladder neoplasms, 70% of them being low-grade (G1). These tumors present a 15-38% chance of recurrence during the first year. The aim of this paper is to identify the predicting factors of the first recurrence in a series of TaG1 primary bladder tumors. METHODS: We have retrospectively analyzed patients who were diagnosed with TaG1 primary bladder tumor by transurethral resection between 2004 and 2012. We established their tumor grade and pathological stage according to the WHO’s classification guides for 1973 and 2004 as well as 2009’s TNM. Those patients who were diagnosed before 2009 did not receive any adjuvant treatment. Those who were diagnosed later on received 40 mg of endovesical Mitomycin C during their immediate post operative period as their only treatment. We define recurrence as the presence of tumor after the first cystoscopy and relapse-free survival (RFS) as the period of time (in months) until the first recurrence appeared. Follow up constitutes the period of time (in months) until the last check-up or first recurrence. We also analyzed different variables: age, gender, smoking habits, muscular representation in the sample, size of the tumor (> or < 1 cm), multiple or single tumors and adjuvant treatment. The survival analysis was performed by the Kaplan-Meier method, using the long-rank test to evaluate the differences between groups. RESULTS: 68 patients were included in the study (73.5 % men, 75% smokers). The average age was 61.9 years (the median being 58.5). Average follow up was 33.2 months (median 28.4). 35.3% of patients experienced recurrence. Average RFS was 19.2 ± 12.7 months (median 13.5). The majority of tumors were of a single nature (77.9%), with a size of less than 1 cm (55.9%) and with muscle representation (52.9%). 57.4% of patients did not receive adjuvant treatment. Only the absence of adjuvant treatment was associated with recurrence in uni and multivariate analysis (p<0,001), with a relative risk of 17,5 IC95% (7,6-30,2). CONCLUSION: The absence of adjuvant therapy with Mitomycin C is the only factor that, in a statistically significant way, increases the risk of recurrence, regardless of demographic factors and the characteristics of the tumor

Predictive postoperative model for biochemical recurrence in patients with localized prostate cancer treated with radical prostatectomy as monotherapy.

OBJECTIVES: To identify the post-prostatectomy prognostic factors of biochemical recurrence (BCR) and develop a predictive model for BCR based on predictive pathological variables after radical prostatectomy (RP). METHODS: We retrospectively analysed patients with clinically localised prostate cancer treated with RP as monotherapy with a minimum follow up period of 12 months. We considered BCR to be the persistence or elevation of PSA levels after RP of> 0,4 ng/ml, and rising in the following determination. We performed uni-and multivariate analysis, using the logistic regression test to determine the variables associated with BCR. We developed a mathematical model to estimate BCR, based on the variables identified, with a logistic function equation and then designed an Excel spreadsheet to apply it. Calibration and discrimination were performed by way of a Hosmer-Lemeshow test and an ROC curve. RESULTS: 693 patients were included. Average age was 63.5 years and average follow up was 88.5 months. BCR was observed in 218 patients. The average time to BCR was 35.5 months, and 90% of the cases occurred in the first 7 years. In the multivariate analysis, the PSA, Gleason Score (GS) = 7(4+3), pathological stage pT3b and affectation of the surgical margin (SM) were identified as independent prognostic pathological variables related to BCR (p〈0,001). The above four variables were included into the equation of the model. Specificity and sensitivity were 90.6% and 50.2%. Its predictive capacity was 80.5% (CI 95% 76,80 -84.3). CONCLUSIONS: PSA, GS = 7(4+3), pathological stage pT3b and PSM were found to be the independent prognostic pathological variables related to BCR-free survival. The predictive model developed permits BCR risk estimation with a reliability of 80.5%

Modelo predictivo postoperatorio para la recidiva bioquímica en pacientes con cáncer de próstata localizado tratados con prostatectomía radical en monoterapia / Predictive postoperative model for biochemical recurrence in patients with localized prostate cancer treated with radical prostatectomy as monotherapy

OBJETIVO: Identificar los factores pronósticos de recidiva bioquímica (RB) post-prostatectomía radical y elaborar un modelo predictivo para la RB basado en las variables obtenidas. MÉTODOS: Analizamos retrospectivamente los pacientes con cáncer de próstata clínicamente localizado tratados con PR en monoterapia con seguimiento mínimo de 12 meses. Consideramos como RB la elevación del PSA después de la PR > 0,4 ng/ml. Realizamos un análisis uni y multivariante mediante regresión logística para determinar las variables asociadas con la RB. Desarrollamos un modelo matemático para estimar probabilidad de RB según la ecuación de función logística y una hoja de cálculo en Excel para su aplicación. La calibración y discriminación se realizaron mediante la prueba de Hosmer-Lemeshow y una curva ROC. RESULTADOS: Incluimos 693 pacientes con una edad media de 63,5 años y un seguimiento medio de 88,5 meses. En 218 pacientes se observó RB. El tiempo medio hasta la RB fue 35,5 meses, aconteciendo el 90% en los 7 primeros años. En el análisis multivariante el PSA, el Score Gleason (SG) ≥ 7(4+3), el estadio pT3b y la afectación del margen quirúrgico (MQP) resultaron variables patológicas independientes relacionadas con la RB. La especificidad, sensibilidad y capacidad predictiva del modelo fueron 90,6%, 50,2% y 80,5%respectivamente (IC95% 76,80 -84,3). CONCLUSIONES: El PSA, el SG ≥ 7(4+3), el estadio patológico pT3b y el MQP son las variables patológicas pronosticas independientes relacionadas con la supervivencia libre de RB. El modelo predictivo desarrollado permite estimar con una fiabilidad del 80,5% el riesgo de RB

OBJECTIVES: To identify the post-prostatectomy prognostic factors of biochemical recurrence (BCR) and develop a predictive model for BCR based on predictive pathological variables after radical prostatectomy (RP). METHODS: We retrospectively analysed patients with clinically localised prostate cancer treated with RP as monotherapy with a minimum follow up period of 12 months. We considered BCR to be the persistence or elevation of PSA levels after RP of > 0,4 ng/ml, and rising in the following determination. We performed uni- and multivariate analysis, using the logistic regression test to determine the variables associated with BCR. We developed a mathematical model to estimate BCR, based on the variables identified, with a logistic function equation and then designed an Excel spreadsheet to apply it. Calibration and discrimination were performed by way of a Hosmer-Lemeshow test and an ROC curve. RESULTS: 693 patients were included. Average age was 63.5 years and average follow up was 88.5 months. BCR was observed in 218 patients. The average time to BCR was 35.5 months, and 90% of the cases occurred in the first 7 years. In the multivariate analysis, the PSA, Gleason Score (GS) . 7(4+3), pathological stage pT3b and affectation of the surgical margin (PSM) were identified as independent prognostic pathological variables related to BCR (p<0,001). The above four variables were included into the equation of the model. Specificity and sensitivity were 90.6% and 50.2%. Its predictive capacity was 80.5% (CI 95% 76,80 . 84.3). CONCLUSIONS: PSA, GS . 7(4+3), pathological stage pT3b and PSM were found to be the independent prognostic pathological variables related to BCR-free survival. The predictive model developed permits BCR risk estimation with a reliability of 80.5%

Utilidad del nomograma del Memorial Sloan Kettering Cancer Center en el pronóstico de los pacientes tratados con cistectomía radical por cáncer vesical infiltrante / Usefulness of the Memorial Sloan Kettering Cancer Center Nomogram in the prognosis of patients treated with radical cystectomy for invasive bladder cancer

OBJETIVO: Valorar la utilidad del nomograma del Memorial Sloan Kettering Cancer Center (MSKCC) para predecir la probabilidad de recidiva en nuestra serie de pacientes sometidos a cistectomía radical por cáncer de vejiga. MÉTODOS: Un total de 397 pacientes fueron sometidos a cistectomía radical por carcinoma vesical entre los años 1986 y 2005 ambos inclusive. Excluimos 165 pacientes: 21 por exitus en el postoperatorio inmediato, 32 por radioterapia previa, 6 por quimioterapia neoadyuvante, 5 por imposibilidad de seguimiento, 15 en los que no se realizó linfadenectomía y 86 vivos en el momento de la revisión con un seguimiento inferior a cinco años. Los pacientes fueron clasificados según grupos de riesgo de recidiva en: tumor órganoconfinado (pT0-T2 N0), localmente avanzado (pT3-T4 N0) y afectación ganglionar (pN+). Realizamos un análisis de supervivencia mediante el método Kaplan-Meier y comparamos mediante una curva ROC la supervivencia libre de recidiva a cinco años por grupos de riesgo de nuestra serie, con la estimada mediante el nomograma del MSKCC. RESULTADOS: Analizamos 232 pacientes. El 90% fueron varones y la edad media 62,5 años. El estudio anatomopatológico reveló 99 (42,7%) tumores organoconfinados, 77 (33,2%) con afectación extravesical y 56 (24,1%) con afectación ganglionar. El seguimiento en los pacientes muertos por cáncer fue de 25 ± 25 meses, con una mediana de 17. En los pacientes vivos o muertos por otras causas el seguimiento fue de 120 ± 39 meses, y la mediana 115,5. La mortalidad cáncer especifica fue del 59,5%. La supervivencia libre de recidiva a cinco años estimada y estratificada por grupos de riesgo fue: pT0-2 76%, pT3-4 51%, pN+ 31%. La probabilidad de supervivencia libre de recidiva según el nomograma del MSKCC en los mismos grupos fue: 85% ±5% en tumores organoconfinados, 62% ± 10% en casos de afectación extravesical, y 25% ± 13% en pacientes con metástasis ganglionares. El área bajo la curva ROC obtenida fue 0.795 (IC 95% 0.739-0.852). CONCLUSIÓN: En nuestra serie, el nomograma del MSKCC constituye una herramienta útil para predecir la supervivencia libre de recidiva a 5 años en los pacientes sometidos a cistectomía radical (AU)

OBJECTIVES: To evaluate the usefulness of the Memorial Sloan Kettering Cancer Center (MSKCC) nomogram for prediction of recurrence probability in our series of patients who have undergone radical cystectomy for bladder cancer. METHODS: 397 patients underwent radical cystectomy for bladder cancer between 1986 and 2005. 165 patients were excluded: 21 due to exitus in the immediate postoperative period, 32 due to previous radiation therapy, 6 due to neoadjuvant chemotherapy, 5 due to inability to complete follow-up, 15 that did not undergo lymphadenectomy and 86 who were alive at the time of review with less than 5 years of follow-up. Patients were clasified into recurrence risk groups: organ-confined tumors (pT0-2 pN0), extra-bladder involvement (pT3-4 pN0) and lymph node involvement (pN+). Survival analysis was performed using the Kaplan-Meier method. Five-year recurrence-free survival by risk groups in our series was compared with the one estimated using the MSKCC nomogram using a ROC curve. RESULTS: We analyzed 232 patients. Follow-up in patients who died of cancer was 25 ± 25 months. For alive patients and those who died of other causes, follow-up was 120 ± 39 months. Pathology studies revealed 42.7% organ-confined tumors , 33.2% with extra-bladder involvement and 24.1% with lymph node involvement. The five-year recurrence free survival analysis according to the Kaplan-Meier method stratified by risk groups was: pT0-2 76%, pT3-4 51%, pN+ 31%. The probability of recurrence free survival according to the MSKCC nomogram in the same risk groups was: 85% ± 5%, 62% ± 10% and 25% ± 13%, respectively. The area under the ROC curve was 0.795 (95% CI 0.739-0.852). CONCLUSION: In our series, the MSKCC nomogram constitutes a useful tool for predicting 5-year cancer free survival in patients who undergo radical cystectomy (AU)

Factores predictores de éxito y necesidad de ingreso en la ureteroscopia semirigida en régimen ambulante / Predictors of success and hospitalization in semi-rigid ureteroscopy for lithiasis as an outpatient procedure

OBJETIVO: La ureteroscopia constituye una opción con elevadas tasas de éxito en el tratamiento de los cálculos ureterales, siendo superiores a la litotricia en la mayoría de los casos. El objetivo de nuestro trabajo es analizar las variables clínicas y demográficas, resultados y complicaciones, de nuestra serie de pacientes sometidos a ureteroscopia en régimen de cirugía mayor ambulatoria (CMA) y analizar los factores predictores de éxito del tratamiento y necesidad de ingreso hospitalario. MÉTODOS: Analizamos de forma retrospectiva 402 pacientes sometidos a ureteroscopia semirrígida (URS) por litiasis ureteral en régimen de CMA en nuestro centro entre 2004 y 2012. Excluimos los pacientes con catéter doble jota (CDJ) previo. Clasificamos las litiasis según su localización (lumbar, iliaca, pélvica) tamaño (< o > 1cm) y número (única o múltiple). El tratamiento se realizó mediante extracción con pinzas, LASER Holmium, o fragmentación mecánica. La revisión se realizó mediante radiografía simple de abdomen y ecografía al mes de la intervención. Consideramos éxito del procedimiento los pacientes libres del cálculo tratado o con restos litiásicos ureterales <3 mm al mes de la intervención. Realizamos un análisis univariante y multivariante mediante chi cuadrado y regresión logística para identificar los factores implicados en el éxito y la no necesidad de hospitalización. RESULTADOS: Incluimos 269 pacientes, 59% varones. La mayoría de la litiasis fueron únicas (92,2%), menores de un centímetro (76,6%), de localización pélvica (62,1%) e izquierdas (57,2%). Realizamos dilatación neumática del orificio ureteral en 67,3% de los casos, tratamos la mayoría de las litiasis con LASER (48%) y dejamos CDJ postoperatorio en el 92,2% de los casos. En el 83,3% de los procedimientos no existieron complicaciones intraoperatorias, realizándose el 89,6% en CMA, considerándolo éxito en el 82,2%. En el análisis multivariante, la lateralidad izquierda (p<0,001) y la localización pélvica de la litiasis (p=0,01) resultaron factores predictivos independientes de éxito del procedimiento. Para la necesidad de ingreso hospitalario solo la ausencia de complicaciones intraoperatorias resulto factor predictivo independiente (p=0,006). CONCLUSIONES: La lateralidad izquierda y la localización pélvica constituyen los factores predictores independientes de éxito de la URS. La ausencia de complicaciones intraoperatorias constituye el factor predictor independiente de no precisar hospitalización (AU)

OBJECTIVES: To analyze the outcomes, predictors of success and predictors of need for hospital admission in our series of patients who underwent ureteroscopy (URS) as a major outpatient surgery (MOS) procedure. METHODS: We carried out a retrospective analysis of 402 patients who had undergone semi-rigid URS for ureteral calculi as a MOS procedure in our center between 2004 and 2012. Patients with previous DJ catheter were excluded. We classified the calculi according to their location (lumbar, pelvic, iliac), size (< or > 1cm) and number (single or multiple). Follow-up was done by plain X-ray of the abdomen and ultrasound one month after surgery. The procedure was considered successful when patients were free from the treated calculi or had ureteral fragments <3 mm one month after surgery. Univariate and multivariate analyses were carried out to identify the factors involved in success and hospitalization not being required. RESULTS: A total of 269 patients were included. The majority of the stones were single (92.2%), <1 cm in size (76.6%), pelvic (62.1%), and left-sided (57.2%). 89.6% of the procedures were performed as MOS and 82.2% were considered to be successful. In the multivariate analysis, left-sided (p<0.001) and pelvic location of the calculi (p=0,01) were found to be independent predictors for the success of the procedure In terms of hospital admission, the only independent predictor was the presence of intraoperative complications (p=0.006). CONCLUSIONS: Left-sided and pelvic locations were the independent predictors for the success of the URS. A lack of intraoperative complications was the independent predictor for not requiring hospitalisation (AU)

Factores post prostatectomía radical predictores de recidiva bioquímica / Post radical prostatectomy predictive factors for biochemical recurrence

OBJETIVO: Identificar los factores pronósticos post-prostatectomía radical (PR) de recidiva bioquímica (RB). MÉTODOS: Analizamos retrospectivamente los pacientes con cáncer de próstata clínicamente localizado tratados con PR en monoterapia pN0-pNx, con un seguimiento mínimo de 12 meses entre 1996 y 2007. Consideramos como RB la persistencia o elevación del PSA después de la PR > 0,4 ng/ml en ascenso en la siguiente determinación. Las variables analizadas fueron el estadio patológico, el score de Gleason, la afectación tumoral del margen quirúrgico, la invasión capsular y la invasión perineural. Realizamos un análisis uni y multivariante mediante chi cuadrado y modelo de riesgos proporcionales de Cox para determinar las variables asociadas con la RB. RESULTADOS: Incluimos 693 pacientes. La edad media fue 63,5 años con un seguimiento medio de 88,5 meses. La media de PSA fue 9,2 ng/ml. En 218 pacientes se observó RB, debiéndose en 43 a persistencia bioquímica. Los hallazgos patologicos mas frecuentes en la pieza de prostatectomia fueron el score 7 de Gleason (47,1%), el estadio patológico pT2c (60,1%). El tiempo medio hasta la RB fue 35,5 meses, aconteciendo el 91,2% en los 8 primeros años. En el análisis multivariante el Score Gleason (SG) ≥ 7(4+3), el estadio patológico pT3b y la afectación tumoral del margen quirúrgico de resección se identificaron como variables patológicas pronosticas independientes relacionadas con la RB. CONCLUSIONES: El PSA, el SG ≥ 7(4+3), el estadio patológico pT3b y la afectación tumoral del margen quirúrgico son las variables patológicas pronosticas independientes relacionadas con la supervivencia libre de RB (AU)

OBJECTIVES: To identify post-prostatectomy prognostic factors for biochemical recurrence (BR). METHODS: We retrospectively analyze a series of patients with clinically localized prostate cancer who were treated with radical prostatectomy (RP) as monotherapy between 1996 and 2007, pN0-pNx, with a minimum of 12 months of follow-up. BR is considered to be persistence or elevation in PSA after RP greater than 0.4 ng/ml on the subsequent determination. Analyzed variables were Gleason Score, pathological stage, surgical margin involvement, capsular involvement, and perineural involvement. We performed univariate and multivariate analysis using the chi squared test and proportional Cox risk model in order to determine the variables associated with BR. RESULTS: We included 693 patients. Mean age was 63.5 years with a mean follow-up of 88.5 months. Mean PSA was 9.2 ng/ml. BR was observed in 218 patients, 43 due to biochemical persistence. More common pathological findings were Gleason score 7 (47.1%), and pathological stage pT2c (60.1%). Mean time to BR was 35.5 months with 91.2% occurring in the first 8 years. On multivariate analysis, Gleason score ≥ 7(4+3), pathological stage pT3b and positive surgical margin were independent predictors of BR. CONCLUSIONS: Gleason Score ≥ 7(4+3), positive surgical margins and pathological stage pT3 are independent prognostic factors associated with BR-free survival (AU)

[Prognostic factors of spontaneous expulsion in ureteral lithiasis]. / Factores predictivos para la expulsión de la litiasis ureteral.

UNLABELLED: Medical treatment, extracorporeal shock wave lithotripsy (ESWL) and ureteroscopy are therapeutic options for ureteral stones. EWSL and endoscopic treatment of ureteral stones have a high success rate. However it has surgical as well as anaesthetic risks. For many patients, a medicinal treatment without invasive procedures is an option. Watchful waiting does not always result in stone clearance and may be associated with recurrent renal colic. The study of the prognostic factors for expulsion and the medical therapy will help us to select candidates for medical expulsive treatment. OBJECTIVES: To evaluate the characteristics of the stones and the medication administered (alpha blockers, NSAIDs or a combination of both) as predictors of spontaneous passage of the stone. MATERIAL AND METHODS: A retrospective observational study of 260 patients with 278 ureteral stones was conducted. Primary endpoint was stone expulsion. Univariate and multivariate analysis were conducted testing the effect of stone location, size and composition, and medication (alpha-blockers, NSAIDs, or combination) on stone clearance. RESULTS: 34,2% of the stones studied were spontaneously eliminated. Stone location (pelvic ureter, OR=1.823, p=0.013), size (>5 mm, OR=3.37, p>0.02), and medication (combination of alpha blockers and NSAIDs, OR=8.70, >0.001) were predictors of spontaneous clearance. Multivariate analysis confirmed size (p=0.006) and medication (p>0.001) as independent predictive factors.The use of the combination of NSAIDs and alpha-blockers versus observation multiplied times 8.21 (95%CI 3.37-20.01) the possibilities of spontaneous expulsion. CONCLUSIONS: Size of stone and medication were confirmed as independent factors for spontaneous expulsion of ureteral stones.

Factores predictivos para la expulsión de la litiasis ureteral / Prognostic factors of spontaneous expulsion in ureteral lithiasis

El tratamiento médico, la litotricia y la ureteroscopia son opciones terapéuticas para el tratamiento de la litiasis ureteral. La ureteroscopia y la litotricia son altamente resolutivas, si bien no están exentas de riesgos quirúrgicos y anestésicos. El tratamiento médico expulsivo es menos efectivo pero carece de esos riesgos. La selección de enfermos para el tratamiento médico debe ser cuidadosa, atendiendo a factores como el tamaño, la composición y la localización de la litiasis. Objetivos: Analizar retrospectivamente el papel de las características litiásicas y de la medicación (alfabloqueantes, antiinflamatorios no esteroideos [AINE] o la combinación de ambos) como factores predictivos de la expulsión de cálculos ureterales. Material y métodos: Para el estudio se encontraron disponibles 278 litiasis ureterales correspondientes a 260 enfermos. La variable principal del estudio fue el «resultado clínico» (expulsión o persistencia de la litiasis). Se analizaron la influencia de la localización, el tamaño, la composición y la medicación administrada (alfabloqueantes, AINE o la combinación de ambos) con el test de la chi cuadrado. A continuación, se llevó a cabo un análisis multivariante con un modelo de regresión logística para estudiar la influencia de cada una de las variables en presencia del resto de las covariables. Resultados: Se produjo la expulsión del 34,2% de las litiasis. La localización (uréter pelviano, odds ratio [OR]= 1,823; p=0,02), el tamaño (<5mm, OR=3,37; p<0,001) y la medicación administrada (combinación de alfabloqueantes y AINE, OR=8,70; p<0,001) resultaron factores predictivos para la expulsión. El análisis multivariante confirmó al tamaño (p=0,006) y a la medicación (p<0,001) como factores predictivos independientes. El tratamiento con una combinación de AINE y alfabloqueantes multiplica por 8,21 (intervalo de confianza del 95%: 3,37–20,01) las posibilidades de expulsión en comparación con la mera actitud expectante. Conclusiones: El tamaño del cálculo y la medicación son factores predictivos independientes para la expulsión de la litiasis ureteral (AU)

Medical treatment, extracorporeal shock wave lithotripsy (ESWL) and ureteroscopy are therapeutic options for ureteral stones. EWSL and endoscopic treatment of ureteral stones have a high success rate. However it has surgical as well as anaesthetic risks. For many patients, a medicinal treatment without invasive procedures is an option. Watchful waiting does not always result in stone clearance and may be associated with recurrent renal colic. The study of the prognostic factors for expulsion and the medical therapy will help us to select candidates for medical expulsive treatment. Objectives: To evaluate the characteristics of the stones and the medication administered (alpha blockers, NSAIDs or a combination of both) as predictors of spontaneous passage of the stone. Material and methods: A retrospective observational study of 260 patients with 278 ureteral stones was conducted. Primary endpoint was stone expulsion. Univariate and multivariate analysis were conducted testing the effect of stone location, size and composition, and medication (alpha-blockers, NSAIDs, or combination) on stone clearance. Results: 34,2% of the stones studied were spontaneously eliminated. Stone location (pelvic ureter, OR= 1,823, p=0,013), size (<5mm, OR=3,37, p<0,02), and medication (combination of alpha blockers and NSAIDs, OR= 8,70, p<0.001) were predictors of spontaneous clearance. Multivariate analysis confirmed size (p=0,006) and medication (p<0,001) as independent predictive factors. The use of the combination of NSAIDs and alpha-blockers versus observation multiplied times 8,21 (95% CI 3.37–20,01) the possibilities of spontaneous expulsion. Conclusions: Size of stone and medication were confirmed as independent factors for spontaneous expulsion of ureteral stones (AU)

[Relational database for urinary stone ambulatory consultation. Assessment of initial outcomes]. / Una base de datos relacional para consulta de litiasis urinaria. Evaluación inicial de resultados.

OBJECTIVES: To create a relational database for monitoring lithiasic patients. We describe the architectural details and the initial results of the statistical analysis. METHODS AND MATERIALS: Microsoft Access 2002 was used as template. Four different tables were constructed to gather demographic data (table 1), clinical and laboratory findings (table 2), stone features (table 3) and therapeutic approach (table 4). For a reliability analysis of the database the number of correctly stored data was gathered. To evaluate the performance of the database, a prospective analysis was conducted, from May 2004 to August 2009, on 171 stone free patients after treatment (EWSL, surgery or medical) from a total of 511 patients stored in the database. Lithiasic status (stone free or stone relapse) was used as primary end point, while demographic factors (age, gender), lithiasic history, upper urinary tract alterations and characteristics of the stone (side, location, composition and size) were considered as predictive factors. An univariate analysis was conducted initially by chi square test and supplemented by Kaplan Meier estimates for time to stone recurrence. A multiple Cox proportional hazards regression model was generated to jointly assess the prognostic value of the demographic factors and the predictive value of stones characteristics. RESULTS: For the reliability analysis 22,084 data were available corresponding to 702 consultations on 511 patients. Analysis of data showed a recurrence rate of 85.4% (146/171, median time to recurrence 608 days, range 70-1758). In the univariate and multivariate analysis, none of the factors under consideration had a significant effect on recurrence rate (p=ns). CONCLUSIONS: The relational database is useful for monitoring patients with urolithiasis. It allows easy control and update, as well as data storage for later use. The analysis conducted for its evaluation showed no influence of demographic factors and stone features on stone recurrence.