Efficacy and safety of a hexanic extract of Serenoa repens (Permixon® ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies.

OBJECTIVES: To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon® ; Pierre Fabre Médicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (≥1 year). RESULTS: Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/night (P < 0.001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with α-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5α-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for ≥1 year (n = 447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). CONCLUSION: The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Qmax compared with placebo and had a similar efficacy to tamsulosin and short-term 5-ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the long-term medical treatment of LUTS/BPH.

Supresión androgénica máxima con acetato de abiraterona en cáncer de próstata hormonosensible / Maximal androgen deprivation with abiraterone acetate in hormone sensitive prostate cancer

OBJETIVO: El tratamiento del cáncer de próstata (CP) metastático ha permanecido inalterado durante más de 70 años fundamentado en la deprivación androgénica (DA). En 2015, a raíz de los estudios CHAARTED y STAMPEDE se estableció que la adición de 6 ciclos de docetaxel a la DA se asociaba significativamente con incremento de la supervivencia. En junio de 2017 los estudios LATITUDE y el brazo G del STAMPEDE demuestran que la adición de Abiraterona junto con Prednisona (5 mg/día) a DA se asocia también a un incremento significativo de supervivencia en los pacientes metastáticos. El presente trabajo analiza estos dos estudios. RESULTADOS: LATITUDE demostró una reducción relativa del riesgo de muerte del 38% (HR=0,62, 95% IC, 0,61-0,76) patente en la práctica totalidad de subgrupos. La reducción del riesgo relativo de progresión radiológica fue del 53 % (HR=0,47,IC 95% 0,39-0,55). Los objetivos secundarios como progresión de PSA, tiempo a quimioterapia o a nuevo evento esquelético también son significativamente retrasados. STAMPEDE también demuestra que la combinación con Abiraterona+prednisolona se asocia a un incremento relativo de SV del 37% (HR=0,63;95% IC, 0,52-0,76; p < 0,001) en pacientes M1, no así en los M0. La supervivencia libre de progresión fue muy mejorada en este brazo (HR=0,29;95% IC 0,25-0,34, p < 0,001). Los efectos secundarios referidos muestran el patrón conocido de exceso mineralcorticoide con incremento de HTA, hipokaliemia y elevación de enzimas hepáticas. CONCLUSIONES: La comparación indirecta de los trabajos de docetaxel y abiraterona confirma que tanto poblaciones, como resultados, son superponibles. Dos meta-análisis indirectos comparativos (>6000 pacientes) otorgan beneficio marginal a abiraterona. A favor de Abiraterona juega el ser una medicación oral, cómoda, con buen perfil de tolerancia y efectos secundarios de fácil manejo, útil en pacientes con frecuencia añosos y frágiles en los que la QT pudiera no estar indicada, aún a costa de una exposición al fármaco es más prolongada y de su actual precio. Futuros ensayos, en curso, determinará el perfil de pacientes idóneo, su posicionamiento en el tiempo o una potencial asociación de ambos

OBJECTIVES: Prostate cancer is linked to bone disease by two different entities. On one hand, androgen deprivation therapy (ADT) usually causes osteoporosis, on the other a great number of patients with advanced prostate cancer will present bone bicametastases, that condition not only their vital prognosis but also an important quality of life deterioration. METHODS: We performed a bibliographic review on both the physiology and therapy of osteoporosis secondary to ADT and bone metastasis in prostatic neoplasias. RESULTS: Osteoporosis: Long term ADT is associated with osteopenia/osteoporosis in 80% of the patients, with a 5-20% incidence of osteoporotic fractures. We should monitor bone mineral density before starting ADT therapy and during treatment. Treatment is based on risk factors reduction, regular physical exercise, calcium and vitamin D supplements, and drugs such as biphosphonates or denosumab. Bone metastasis: Currently, both zolendronic acid and denosumab have approval for the prevention of skeletal events in patients with castration resistant prostate cancer (CPRC). Although the last one seems to be more effective, it is associated with a higher risk of hypocalcemia and jaw osteonecrosis so that the choice of drug must be individualized in every patient. The duration of treatment is not clear. Currently, the indication for the use of this drugs in earlier phases of advanced disease is not approved. CONCLUSIONS: Comprehensive management of the patient with advanced prostate cancer should include the study and treatment of osteoporosis and bone metastases. Currently, very effective therapies are available for both entities

Outpatient holmium laser treatment for recurrent low-grade superficial bladder cancer under local anesthesia.

BACKGROUND: The aim of this paper is to analyze the results of a prospective study conducted on a cohort of patients undergoing outpatient holmium laser fulguration. The "gold standard" treatment of superficial bladder cancer is transurethral resection, although in recent years improvements in laser technology and endoscopy equipment have allowed further therapeutic alternatives. METHODS: This is a descriptive study of a cohort of 37 patients with low-risk recurrent superficial bladder cancer undergoing holmium laser fulguration after bladder instillation of local anesthesia. The study included patients with a history of low-risk primary superficial bladder cancer with papillary tumor recurrence, tumor size ≤10 mm, fewer than 5 tumors, absence of carcinoma in situ, negative cytology, no coagulation disorders and no local anesthesia allergies. Demographic variables, previous history of transurethral resection, safety and oncological results after fulguration were analyzed using the SPSS software. Statistical analyses include calculating mean and frequency, and Kaplan-Meier curve for recurrence. RESULTS: Mean age of the patients was 69.2 years with 86.5% being male. The number of tumors was 1.5±0.8 and the overall average size of 5.5±2.7 mm. The mean duration of the endoscopic procedure was 12±4.3 minutes. Hundred percent of patients had scores on the Visual Analogue Scale ≤3. There was only one case of hematuria, who required hospitalization. After a median follow-up period of 13 months, there was a 35.1% recurrence rate with one case of tumor progression. CONCLUSIONS: Holmium laser treatment of recurrent low-risk superficial bladder tumor is a safe and effective alternative, but long-term clinical trials are necessary to increase the current scientific evidence base.

Fulguración con láser de la recidiva de tumores vesicales superficiales bajo anestesia local: diseño de procesos / Laser fulguration of superficial bladder tumor recurrence under local anesthesia. design process

Introduction: The process design is one of the most interesting tools to ensure the quality of health care before the start of an activity. Although the gold standard treatment of superficial bladder tumors remains transurethral resection (TUR), the onset of laser energy source with better endourological systems allows us to adopt alternative therapies. The aim of this pilot study is to describe the design and protocol in 37 patients with a novel process consisting of outpatient treatment under local anesthesia of bladder tumors with holmium laser. Material and Methods: Pilot study includes 37 patients between January 2012 and December 2013, for the development of a process of holmium laser bladder fulguration without anesthetic infiltration in outpatient study. It analyzes and studies the procedure tolerance, development of immediate complications, visual analog scale (VAS) of pain, patient satisfaction, hospital stays avoided, problems during the application process and development. Results: The mean age of the patients was 69.2 +/- 10.3 years, 100 percent of patients prefer this procedure instead conventional transurethral resection and VAS rating presenting ≤ 3. There were no important complications. Only one patient was admitted at hospital due to hematuria resolved without surgical treatment. Conclusions: The development and implementation of fulguration of superficial papillary bladder tumors with holmium laser process is simple, well tolerated, ambulatory and without complications, with no need of hospital stay.

Introducción: El diseño de procesos es una de las herramientas de mayor interés para asegurar la calidad de la asistencia sanitaria antes del comienzo de una determinada actividad. Aunque el gold standard del tratamiento de los tumores vesicales superficiales sigue siendo la resección transuretral (RTU), la aparición de la fuente de energía láser con mejores medios endourológicos nos permite adoptar otras alternativas terapéuticas. El objetivo de este estudio piloto es describir el diseño y protocolo en 37 pacientes de un proceso novedoso consistente en el tratamiento en régimen ambulatorio y bajo anestesia local intravesical de los tumores de vejiga con láser de holmium. Material y Métodos: Estudio piloto que incluye 37 pacientes entre enero de 2012 y diciembre de 2013, para la elaboración de un proceso de fulguración vesical con láser de holmium sin infiltración anestésica en régimen ambulatorio. Se analiza y estudia tolerancia al procedimiento, desarrollo de complicaciones inmediatas, escala visual analógica (EVA) del dolor, satisfacción del paciente, estancias hospitalarias evitadas, problemas durante la aplicación del proceso y desarrollo del mismo. Resultados: La edad media de los pacientes fue 69,2 +/- 10,3 años, presentando puntuación EVA ≤ 3. No existieron complicaciones importantes. Hubo un ingreso por hematuria tardía que se resolvió de forma conservadora. Conclusiones: La elaboración y aplicación del proceso de fulguración de tumores vesicales papilares superficiales con láser holmium es una técnica sencilla, con buena tolerancia, ambulatoria y sin complicaciones de interés, con eliminación de estancias hospitalarias.

[Spontaneous pneumopyelography for enteroureteral fistula]. / Neumopielografía espontánea por fistula enteroureteral.

OBJECTIVES: To report one outstanding case of fever and flank pain with the radiologic finding of air outlining the whole left upper urinary tract (pneumopyelography). METHODS: The patient subject of this case had a history of gynaecologic surgery five years before presentation and subsequent diverticulitis one year later requiring discharge colostomy followed by reconstruction 7 months later. We performed a MEDLINE search using the terms "entero urinary fistula". Most papers are case reports with reviews of the diagnostic and therapeutic procedures, as well as the etiologic factors. RESULTS: Radiologic tests are key to make this finding clear and to determine its location. In our patient, once the acute picture was controlled and the confirmatory diagnosis was made by means of barium enema, we proceeded with left simple nephrectomy and lower intestine resection including the fistula tract. Real incidence is unknown; there is a female predominance in the published cases. Depending on the casual mechanism, they may be classified as spontaneous or traumatic. Most of them are secondary to bowel inflammatory diseases like diverticulitis, Crohn's disease, tumors, ulcers,... They can also be secondary to impacted urinary lithiasis, urothelial tumor, endoscopic procedures, etc. Other cases are secondary to previous surgery and radiotherapy. CONCLUSIONS: The finding of pneumopyelogram should prompt and interventional algorithm including radiologic tests and other examinations to allow a proper diagnosis and to perform an effective treatment.

Neumopielografía espontánea por fístula enteroureteral / Spontaneous pneumopyelography secondary to entero-urinary fistula

OBJETIVOS: Presentar un caso llamativo de dolor lumbar y fiebre con el hallazgo en la radiografía de aparato urinario de "aire" que dibuja todo el árbol urinario izquierdo (neumopielografía). MATERIAL Y MÉTODOS: La paciente motivo de este caso relataba dentro de sus antecedentes cirugía ginecológica hacía 5 años y episodio de diverticulitis hacía 4 que requirió colostomía de descarga con reconstrucción del tránsito a los 7 meses del cuadro. Realizamos una búsqueda bibliográfica electrónica en PubMed (MEDLINE) utilizando los términos "enterourinary fistula". La gran mayoría de las publicaciones corresponden a aportación de casos nuevos con revisión de los procedimientos diagnósticos y terapéuticos y su etiología. RESULTADOS: Tanto en el caso que presentamos como los que aporta la literatura, las pruebas radiológicos son determinantes para poner de manifiesto el hallazgo y el nivel. En nuestra paciente una vez que controlamos el cuadro agudo y diagnosticamos la fístula de forma concluyente con enema opaco, practicamos nefrectomía simple izquierda y resección baja de intestino que abarcaba el trayecto fistuloso.La incidencia real es desconocida, existiendo un predomino de mujeres en los casos publicados. Se pueden clasificar en espontáneas o traumáticas según el mecanismo de producción. La gran mayoría se producen por enfermedad inflamatoria del tubo digestivo como una diverticulitis, enfermedad de Crohn, tumores, úlceras ,.... También puede ocurrir por impacto de litiasis urinaria, tumor urotelial, procedimientos endoscópicos, etc. En otros casos es debido a cirugía previa y radioterapia. CONCLUSIONES: La presencia de una imagen de neumopielograma tiene que poner en marcha un algoritmo de actuación a través de pruebas radiológicas y otras exploraciones que permita un correcto diagnostico y permita realizar un tratamiento efectivo (AU)