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1.
Arch Esp Urol ; 75(3): 248-255, 2022 Apr.
Artigo em Espanhol | MEDLINE | ID: mdl-35435169

RESUMO

INTRODUCTION: The increased incidenceof diagnosis of kidney tumours has driveninvestigation in the area. It is known that the risk ofmalignancy is correlated with tumour size, but thereare still no specific and objective parameters to characterizethe degree of aggressiveness and to be ableto guide a treatment reliably. OBJECTIVE: To identify the relationship betweenrenal tumour size and the incidence of tumour aggressivecharacteristics. PATIENTS AND METHODS: A retrospective analysisof our series of renal cancers operated between 1998and 2018 was performed. The specific and cumulativeincidence of aggressive characteristics was studied.The following where considered as aggressive characteristics:Presence of sarcomatoid or epidermoiddifferentiation, tumour necrosis, stage pT3-4, histologicalhigh grade (3-4) and the presence of histologicalaggressive variants. RESULTS: A total of 651 patients that had undergonerenal mass surgery were analysed. In tumours below2 cm the appearance of aggressive characteristicsoccurred in less than 5%. For renal masses greaterthan 2 cm, each centimetre increase correlated with arise in cumulative incidence of 2-3% for each characteristicstudied. CONCLUSIONS: In tumours below 2cm and patientswith significant comorbidities active surveillance maybe a reliable alternative to surgery.


INTRODUCCIÓN: El aumento de incidenciade diagnóstico de tumores renales ha conllevadoun mayor estudio y conocimiento de los mismos.Se conoce que el riesgo de malignidad se correlacionacon el tamaño tumoral, pero seguimos sin tener parámetrosespecíficos y objetivos para caracterizar elgrado de agresividad de los mismos y poder orientarun tratamiento de forma fiable. OBJETIVO: Identificar la relación que existe entre eltamaño tumoral y la incidencia de características deagresividad.MATERIAL Y MÉTODOS: Análisis retrospectivo denuestra serie de cáncer renal intervenido quirúrgicamenteen el periodo entre 1998 y 2018. Se estudia laincidencia específica y acumulada de las característicasde agresividad en dichas lesiones y su relación conel tamaño tumoral. Se consideraron característicasde agresividad: la presencia diferenciación sarcomatoiode epidermoide, necrosis tumoral, estadio pT3-4,grado histológico alto (3-4) y la presencia de variantesde histología agresiva. RESULTADOS: Se analizan un total de 651 pacientesintervenidos por cáncer renal. En tumores por debajode 2 cm la aparición de características de agresividadse observó en menos del 5%. A partir de ese tamaño, laincidencia acumulada se incrementa en un 2-3% paracada característica con cada centímetro que aumentael tamaño tumoral. CONCLUSIONES: Este análisis demuestra que conformeaumenta el tamaño de los tumores renales, aumentala incidencia de características de agresividadde los mismos. En tumores por debajo de 2 cm y pacientescon comorbilidades importantes la vigilanciaactiva puede ser una alternativa con cierta seguridad.


Assuntos
Carcinoma de Células Renais , Neoplasias Renais , Carcinoma de Células Renais/cirurgia , Feminino , Humanos , Rim/patologia , Neoplasias Renais/patologia , Neoplasias Renais/cirurgia , Masculino , Nefrectomia , Estudos Retrospectivos
2.
Arch. esp. urol. (Ed. impr.) ; 75(3): 248-255, abr. 28, 2022. tab
Artigo em Espanhol | IBECS | ID: ibc-203687

RESUMO

INTRODUCCIÓN: El aumento de incidencia de diagnóstico de tumores renales ha conllevado un mayor estudio y conocimiento de los mismos.Se conoce que el riesgo de malignidad se correlacionacon el tamaño tumoral, pero seguimos sin tener parámetros específicos y objetivos para caracterizar elgrado de agresividad de los mismos y poder orientarun tratamiento de forma fiable.OBJETIVO: Identificar la relación que existe entre eltamaño tumoral y la incidencia de características deagresividad.MATERIAL Y MÉTODOS: Análisis retrospectivo denuestra serie de cáncer renal intervenido quirúrgicamente en el periodo entre 1998 y 2018. Se estudia laincidencia específica y acumulada de las características de agresividad en dichas lesiones y su relación conel tamaño tumoral. Se consideraron característicasde agresividad: la presencia diferenciación sarcomatoiode, epidermoide, necrosis tumoral, estadio pT3-4,grado histológico alto (3-4) y la presencia de variantesde histología agresiva.RESULTADOS: Se analizan un total de 651 pacientesintervenidos por cáncer renal. En tumores por debajode 2 cm la aparición de características de agresividadse observó en menos del 5%. A partir de ese tamaño, laincidencia acumulada se incrementa en un 2-3% paracada característica con cada centímetro que aumentael tamaño tumoral.CONCLUSIONES: Este análisis demuestra que conforme aumenta el tamaño de los tumores renales, aumenta la incidencia de características de agresividadde los mismos. En tumores por debajo de 2 cm y pacientes con comorbilidades importantes la vigilanciaactiva puede ser una alternativa con cierta seguridad. (AU)


INTRODUCTION: The increased incidence of diagnosis of kidney tumours has driveninvestigation in the area. It is known that the risk ofmalignancy is correlated with tumour size, but thereare still no specific and objective parameters to characterize the degree of aggressiveness and to be ableto guide a treatment reliably. OBJECTIVE: To identify the relationship betweenrenal tumour size and the incidence of tumour aggressive characteristics.PATIENTS AND METHODS: A retrospective analysisof our series of renal cancers operated between 1998and 2018 was performed. The specific and cumulativeincidence of aggressive characteristics was studied.The following where considered as aggressive characteristics: Presence of sarcomatoid or epidermoiddifferentiation, tumour necrosis, stage pT3-4, histological high grade (3-4) and the presence of histologicalaggressive variants.RESULTS: A total of 651 patients that had undergone renal mass surgery were analysed. In tumours below 2 cm the appearance of aggressive characteristicsoccurred in less than 5%. For renal masses greaterthan 2 cm, each centimetre increase correlated with arise in cumulative incidence of 2-3% for each characteristic studied.CONCLUSIONS: In tumours below 2cm and patientswith significant comorbidities active surveillance maybe a reliable alternative to surgery. (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Neoplasias Renais/patologia , Estudos Retrospectivos , Estadiamento de Neoplasias , Neoplasias Renais/cirurgia , Invasividade Neoplásica
3.
Int Urol Nephrol ; 54(5): 1039-1045, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35249203

RESUMO

BACKGROUND: Non-traumatic obliterative bulbar urethral stricture with residual urethral lumen below 3 Fr is a challenging surgical scenario for reconstructive surgeons, because either anastomotic or single augmentation urethroplasty is not an option. OBJECTIVES: To describe our double-face buccal mucosa graft (BMG) urethroplasty with dorsal onlay and ventral inlay relying on the vessels and nerve-sparing technique of Kulkarni's one-side dissection. METHODS: We retrospectively reviewed a prospectively maintained database of patients with non-traumatic obliterative bulbar urethral strictures who underwent double-face bulbar urethroplasty with one-side dissection and dorsal onlay plus ventral inlay BMG. Patient demographics, clinical data, and follow-up were analyzed. RESULTS: A total of 59 patients underwent double-face urethroplasty with dorsal approach. The median age was 37 years (IQR 27-49) and the median stricture length was 5 cm (IQR 3.75-6). No patients had immediate post-operative complications. The overall success rate was 88% with a median follow-up of 30.9 months (IQR 16.9-44.2). Two patients were treated with DVIU, and two patients with open urethral surgery. One patient developed erectile dysfunction after surgery. Age, etiology, stenosis length and previous treatment were not factors related to surgical failure. CONCLUSION: Our preliminary albeit encouraging results showed that this approach was feasible in all patients and with negligible perioperative complications. Success rate was 88%. We did not find any factors related to surgical failure. Our dorsal double-face augmented urethroplasty may be a valid alternative to the Palminteri's ventral double-face urethroplasty, especially in those patients with mid-distal bulbar or peno-bulbar urethral strictures.


Assuntos
Estreitamento Uretral , Adulto , Constrição Patológica/cirurgia , Humanos , Masculino , Mucosa Bucal/transplante , Estudos Retrospectivos , Resultado do Tratamento , Uretra/cirurgia , Estreitamento Uretral/etiologia , Estreitamento Uretral/cirurgia , Procedimentos Cirúrgicos Urológicos Masculinos/métodos
4.
Arch Esp Urol ; 75(2): 165-172, 2022 Mar.
Artigo em Espanhol | MEDLINE | ID: mdl-35332886

RESUMO

INTRODUCTION: The use of prostatespecific antigen (PSA) is useful for the diagnosis ofprostate cancer. Its main limitation is its low specificity,which has led to the search for new biomarkersin order to identify clinically significant prostatecancer and to reduce overdiagnosis and overtreatment.The aim of this article is to summarize the currentliterature on urinary biomarkers used in thediagnosis of prostate cancer.A PubMed-based literature search was conductedup to December 2020. We selected the most recentand relevant original articles, clinical trials and reviewsthat have provided relevant information onthe use of biomarkers.In this review, we have discussed four importanturinary biomarkers useful for prostate cancer diagnosis:PCA3, Select MDX, ExoDX, TMPRSS2:ERG. CONCLUSION: The use of urinary biomarkers hasimproved of clinically significant prostate cancerdiagnosis. Their use reduces the number of unnecessarybiopsies and avoids overtreatment of indolentprostate cancer.


INTRODUCCIÓN: El uso del antígenoprostático específico (PSA) es útil para el diagnósticodel cáncer de próstata. Su principal limitación es labaja especificidad, esto ha llevado a la búsqueda denuevos biomarcadores con el fin de identificar el cáncerde próstata clínicamente significativo y poder disminuirel sobrediagnóstico y sobretratamiento.El objetivo de este artículo es resumir la literaturaactual sobre los biomarcadores urinarios utilizados enel diagnóstico de cáncer de próstata.Se llevó a cabo una búsqueda bibliográfica en Pub-Med hasta diciembre del 2020. Hemos seleccionadolos artículos originales, ensayos clínicos y revisionesmás recientes que proporcionan información sobre eluso de biomarcadores.En esta revisión, hemos discutido cuatro importantesbiomarcadores urinarios útiles para el diagnósticodel cáncer de próstata: PCA3, Select MDX, ExoDX, TMPRSS2:ERG.CONCLUSIÓN: El uso de biomarcadores urinariosha mejorado del diagnóstico de cáncer de próstata clínicamentesignificativo. Su uso reduce el número debiopsias innecesarias y evita el sobretratamiento delcáncer de próstata indolente.


Assuntos
Biomarcadores Tumorais , Neoplasias da Próstata , Antígenos de Neoplasias , Biópsia , Humanos , Masculino , Próstata/patologia , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia
5.
Arch. esp. urol. (Ed. impr.) ; 75(2): 165-172, mar. 28, 2022.
Artigo em Espanhol | IBECS | ID: ibc-203678

RESUMO

INTRODUCCIÓN: El uso del antígenoprostático específico (PSA) es útil para el diagnósticodel cáncer de próstata. Su principal limitación es labaja especificidad, esto ha llevado a la búsqueda denuevos biomarcadores con el fin de identificar el cáncer de próstata clínicamente significativo y poder disminuir el sobrediagnóstico y sobretratamiento.El objetivo de este artículo es resumir la literaturaactual sobre los biomarcadores urinarios utilizados enel diagnóstico de cáncer de próstata.Se llevó a cabo una búsqueda bibliográfica en PubMed hasta diciembre del 2020. Hemos seleccionadolos artículos originales, ensayos clínicos y revisionesmás recientes que proporcionan información sobre eluso de biomarcadores.En esta revisión, hemos discutido cuatro importantes biomarcadores urinarios útiles para el diagnósticodel cáncer de próstata: PCA3, Select MDX, ExoDX, TMPRSS2:ERG.CONCLUSIÓN: El uso de biomarcadores urinariosha mejorado del diagnóstico de cáncer de próstata clínicamente significativo. Su uso reduce el número debiopsias innecesarias y evita el sobretratamiento delcáncer de próstata indolente. (AU)


INTRODUCTION: The use of prostatespecific antigen (PSA) is useful for the diagnosis ofprostate cancer. Its main limitation is its low specificity, which has led to the search for new biomarkersin order to identify clinically significant prostatecancer and to reduce overdiagnosis and overtreatment.The aim of this article is to summarize the current literature on urinary biomarkers used in thediagnosis of prostate cáncer.A PubMed-based literature search was conductedup to December 2020. We selected the most recentand relevant original articles, clinical trials and reviews that have provided relevant information onthe use of biomarkers.In this review, we have discussed four importanturinary biomarkers useful for prostate cancer diagnosis: PCA3, Select MDX, ExoDX, TMPRSS2:ERG.CONCLUSION: The use of urinary biomarkers hasimproved of clinically significant prostate cancerdiagnosis. Their use reduces the number of unnecessary biopsies and avoids overtreatment of indolent prostate cancer. (AU)


Assuntos
Humanos , Masculino , Neoplasias da Próstata/diagnóstico , Biomarcadores Tumorais/urina , Antígeno Prostático Específico/urina , Sensibilidade e Especificidade
6.
Minerva Urol Nephrol ; 74(2): 194-202, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34308610

RESUMO

BACKGROUND: The impact of warm ischemia time (WIT) on renal functional recovery remains controversial. We examined the length of WIT>30 min on the long-term renal function following on-clamp partial nephrectomy (PN). METHODS: Data from 23 centers for patients undergoing on-clamp PN between 2000 and 2018 were analyzed. We included patients with two kidneys, single tumor, cT1, minimum 1-year follow-up, and preoperative eGFR≥60 mL/min/1.73m2. Patients were divided into two groups according to WIT length: group I "WIT≤30 min" and group II "WIT>30 min." A propensity-score matched analysis (1:1 match) was performed to eliminate potential confounding factors between groups. We compared eGFR values, eGFR (%) preservation, eGFR decline, events of chronic kidney disease (CKD) upgrading, and CKD-free progression rates between both groups. Cox regression analysis evaluated WIT impact on upgrading of CKD stages. RESULTS: The primary cohort consisted of 3526 patients: group I (N.=2868) and group II (N.=658). After matching the final cohort consisted of 344 patients in each group. At last follow-up, there were no significant differences in median eGFR values at 1, 3, 5, and 10 years (P>0.05) between the matched groups. In addition, the median eGFR (%) preservation and absolute eGFR change were similar (89% in group I vs. 87% in group II, P=0.638) and (-10 in group I vs. -11 in group II, P=0.577), respectively. The 5 years new-onset CKD-free progression rates were comparable in the non-matched groups (79% in group I vs. 81% in group II, log-rank, P=0.763) and the matched groups (78.8% in group I vs. 76.3% in group II, log-rank, P=0.905). Univariable Cox regression analysis showed that WIT>30 min was not a predictor of overall CKD upgrading (HR:0.953, 95%CI 0.829-1.094, P=0.764) nor upgrading into CKD stage ≥III (HR:0.972, 95%CI 0.805-1.173, P=0.764). Retrospective design is a limitation of our study. CONCLUSIONS: Our analysis based on a large multicenter international cohort study suggests that WIT length during PN has no effect on the long-term renal function outcomes in patients having two kidneys and preoperative eGFR≥60 mL/min/1.73m2.


Assuntos
Neoplasias Renais , Isquemia Quente , Estudos de Coortes , Taxa de Filtração Glomerular , Humanos , Neoplasias Renais/patologia , Neoplasias Renais/cirurgia , Nefrectomia/efeitos adversos , Estudos Retrospectivos , Isquemia Quente/efeitos adversos
7.
J Clin Med ; 12(1)2022 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-36614853

RESUMO

INTRODUCTION: The management of traumatic urethral strictures remains a challenge for urologists. Alteration of the pelvic anatomy and the significant fibrosis generated by the trauma make surgical repair complex. In most cases, the existing defect between the urethral ends is small, and the ideal treatment is end-to-end perineal urethroplasty. Cases of extensive strictures that are left with long gap defects may require the use of different sequential maneuvers to achieve a tension-free anastomosis. OBJECTIVE: To describe the experience at our center with urethral strictures induced by closed perineal trauma. MATERIALS AND METHODS: A retrospective analysis of 116 patients who underwent urethroplasty for urethral stricture after blunt perineal trauma at our center between 1965 and 2020 was conducted. Demographic data, date, mechanism of action of the trauma, emergency management, previous urethral interventions, surgical technique carried out in our center, complications, presence of erectile dysfunction, and urinary incontinence were collected. RESULTS: 82 patients (70.7%) presented with pelvic fractures. The most frequent etiology of trauma was traffic accidents (68%), followed by crushing injuries (24%). Suprapubic cystostomy was placed in 50.2% of patients, and urethral realignment was performed in 25.3%. The mean stricture length was 2.2 cm, affecting mostly the membranous urethra (67%). During surgery, it was necessary to perform crural separation in 61.5% and partial pubectomy in 18.8% of the cases. Erectile dysfunction developed after trauma in 40.5% of cases, while new erectile dysfunction was noted in 4.3% of patients after surgery. Surgery was successful in 91.3% of cases, with a median follow-up of 16 (6-47) months. CONCLUSION: Delayed anastomotic urethroplasty offers a high success rate in traumatic urethral strictures.

8.
Arch Esp Urol ; 74(10): 1029-1039, 2021 12.
Artigo em Espanhol | MEDLINE | ID: mdl-34851317

RESUMO

There are different surgical techniques for reconstruction of the urinary tract in kidney transplant. However, urinary complications are frequent in the postoperative period, being the ureter the frequent location of these complications. This results in high health care costs, increasing patient morbimortality and sometimes graft loss. For this reason, prevention, correct diagnosis and treatment are important. The aim of this review is to describe the surgical techniques most commonly used in kidney transplant for ureteroneocystostomy. To analyze the advantages and disadvantages of each of them and to compare their complications. On the other hand, we summarize the recent literature on the four most frequent urinary complications in the postoperative period after transplantation. The possible causes and treatment of urine leak, ureteri cobstruction, hematuria and vesicoureteral reflux are presented.


Existen diferentes técnicas quirúrgicas para la reconstrucción del tracto urinario en el trasplante renal. Sin embargo es frecuente la aparición de complicaciones urinarias en el postoperatorio, siendo el uréterla localización frecuente de las mismas. Esto implica un alto gasto sanitario, aumentando la morbimortalidad del paciente y pudiendo llegar a desencadenar la pérdida del injerto. Por ello es importante la prevención, el correcto diagnóstico y su tratamiento. El objetivo de esta revisión es describir las técnicas quirúrgicas más usadas en el trasplante renal para la ureteroneocistostomía. Analizar las ventajas y desventajas de cada una de ellas y comparar sus complicaciones. Por otro lado se resume la literatura reciente sobre las cuatro complicaciones urinarias más frecuentes en el postoperatorio del trasplante. Se exponen las posibles causas y tratamiento de la fuga urinaria, la obstrucción ureteral, la hematuria y el reflujo ureterovesical.


Assuntos
Transplante de Rim , Ureter , Sistema Urinário , Refluxo Vesicoureteral , Cistostomia , Humanos , Transplante de Rim/efeitos adversos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/terapia , Estudos Retrospectivos
9.
Arch Esp Urol ; 74(9): 883-893, 2021 Nov.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-34726625

RESUMO

OBJECTIVE: Although an immediate postoperative instillation of chemotherapy (IPOIC) after transurethral resection of bladder tumors (TURBT) is recommended for the prevention of recurrences of non-muscleinvasive bladder cancer (NMIBC), evidence shows there is an important compliance failure worldwide. We believe that an immediate neoadjuvant instillation of chemotherapy (INAIC) can act similarly, reducing the recurrence risk of NMIBC. Here we present the interim analysis of the PRECAVE clinical trial. MATERIAL AND METHODS: Patients with clinically diagnosed NMIBC were randomized to receive an INAIC with mitomycin C before TURBT (Group A) or to a control group with TURBT only (Group B). Primary end point was to compare the efficacy of an INAIC in the early recurrence-free survival (RFS). Secondary end points were: RFS in patients who did not receive adjuvant treatments, toxicity, and feasibility. RESULTS: A total of 124 patients with Ta/T1 G1-G3NMIBC were included in the initial analysis (Group A:64, Group B: 60). Demographics, risk classification, complications, and adjuvant treatments were balanced between groups. Eighty-four patients (Group A: 45, Group B: 39) who completed a one-year follow-up were included in the efficacy analysis and no difference was observed in the RFS between groups (p=0.3). In the subgroup of patients who did not receive adjuvant treatments, we found a significant difference in favor of an INAIC (p=0.009) and an 80% reduction in the risk of early recurrences (Hazard Ratio: 0.20; 95% confidence interval: 0.05-0.81; p=0.0024). No differences were observed in adverse events. Only 4 patients did not receive an INAIC despite being planned. CONCLUSIONS: In this interim analysis, although we could not demonstrate a reduction in the RFS of all patients, we did find a significant decrease of recurrences in patients who did not receive adjuvant treatments. The administration of an INAIC seems to be safe and our protocol appears feasible and reproductive.


OBJETIVO: Aunque el uso de una instilación postoperatoria inmediata de quimioterapia (IPOIQ) tras una resección transuretral vesical (RTUV) esta recomendada para prevenir recurrencias de carcinoma vesical no músculo invasivo (CVNMI), no se llega a realizar en muchos casos debido a fallos en su cumplimiento. Nosotros creemos que una instilación neoadyuvante inmediata de quimioterapia (INAIQ) puede actuar de manera similar reduciendo el riesgo de recurrencias. Presentamos el análisis intermedio del ensayo clínico PRECAVE.MATERIAL Y MÉTODOS: Se aleatorizó a pacientes diagnosticados de CVNMI a recibir una INAIQ con mitomicina C antes de la RTUV (Grupo A) o a un grupo control con RTUV solamente (Grupo B). El objetivo primario fue comparar la eficacia de una INAIQ en la supervivencia libre de recurrencia (SLR) temprana. Los objetivos secundarios fueron la SLR en pacientes que no recibieron tratamientos adyuvantes, toxicidad y viabilidad. RESULTADOS: Analizamos un total de 124 pacientes con CVNMI Ta/T1G1-G3 fueron analizados (Grupo A:64, Grupo B: 60). No se encontraron diferencias entre datos demográficos, grupos de riesgo, complicaciones o tratamientos adyuvantes. Para el análisis de eficacias e incluyeron 84 pacientes (Grupo A: 45, Grupo B:39) con al menos un año de seguimiento, sin observar diferencias en la SLR (p=0,3). Sin embargo, en el subgrupo que no recibió tratamientos adyuvantes, sí encontramos una diferencia significativa a favor de la INAIQ (p=0,009), y una reducción del riesgo de recurrencias tempranas del 80% (Hazard Ratio: 0,20; intervalo de confianza 95%: 0,05-0,81; p=0,0024). No se observaron diferencias en la aparición de eventos adversos. Solo 4 pacientes no recibieron un INAIC a pesar de estar planificado. CONCLUSIONES: En este análisis intermedio, aunque no pudimos demostrar una reducción en la SLR de todos los pacientes, sí encontramos una diferencia en el subgrupo que no recibió tratamientos adyuvantes. La administración de una INAIC parece ser segura, y nuestro protocolo parece factible y reproducible.


Assuntos
Neoplasias da Bexiga Urinária , Administração Intravesical , Antibióticos Antineoplásicos/uso terapêutico , Cistectomia , Humanos , Mitomicina/uso terapêutico , Terapia Neoadjuvante , Invasividade Neoplásica , Recidiva Local de Neoplasia/tratamento farmacológico , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/cirurgia
11.
Int J Surg Protoc ; 24: 21-26, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33195885

RESUMO

INTRODUCTION AND OBJECTIVES: Recurrence rates for patients presenting with non-muscle invasive bladder carcinoma (NMIBC) can be as high as 60% during the first year after a transurethral resection of bladder tumor (TURBT). Currently, an immediate postoperative instillation of chemotherapy (IPOIC) is recommended for the prevention of recurrences in patients with low to intermediate risk disease. Although in real clinical practice this specific instillation of chemotherapy has many difficulties to be standardized, including its contraindications (suspected or confirmed bladder perforation, wide or extensive resection and, continuous bladder irrigation requirement), which will only make it feasible for around 30% of patients.We propose in this controlled study, to administer an immediate neoadjuvant instillation of chemotherapy (INAIC), which can be applied technically to all patients, no matter the surgical outcomes and compare it with a control group. We expect to find a reduction in the recurrence rate in the experimental group of at least 15%. METHODS: We designed a phase IV, randomized, controlled, open label clinical trial. Main inclusion criteria are: patients with a clinical diagnosis of localized, papillary-type bladder cancer (suspected low to intermediate risk) with a disease-free interval of at least 6 months. Eligible patients will be allocated into group A (INAIC plus TURBT) or group B (TURBT) using a computer-generated block randomization sequence/ratio 1:1. Time to recurrence of both groups will be analyzed and compared using Kaplan-Meier estimates, log-rank tests and, Cox-regression. Univariate and multivariate analyzes will be performed to determine factors which influence recurrence. The study has received the approval of the Ethics Committee for Drug Research (CEIm) of La Paz University Hospital and the Spanish Agency for Medicines and Health Products.

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