Cost-effectiveness of sacral neuromodulation compared to botulinum neurotoxin a or continued medical management in refractory overactive bladder.

OBJECTIVES: This study assessed the cost-effectiveness and health-care budget impact of sacral neuromodulation (SNM) in refractory idiopathic OAB-wet patients in Spain. METHODS: A 10-year Markov analytic model was developed to estimate quality-adjusted life-years (QALYs) gained and incontinence episode avoided associated with SNM therapy compared with botulinum neurotoxin A (BoNT-A) or continued optimized medical treatment (OMT). RESULTS: At 10 years, the cumulative costs of SNM, BoNT-A, and OMT were €29,166, €29,458, and €29,370, respectively, whereas the QALYs for SNM, BoNT-A, and OMT are 6.89, 6.38, and 5.12, respectively. Consequently, incremental cost-effectiveness ratios (ICERs) for SNM demonstrate that although the initial costs for SNM are higher than those for the other treatments, decreasing follow-up costs coupled with consistently greater effectiveness in the long term make SNM the economically dominant option at 10 years. Sensitivity analyses suggest that 99.7% and 99.9% (for SNM vs. BoNT-A and OMT, respectively) of the 1000 Monte Carlo iterations fall within the €30,000 cost-effectiveness threshold, considered to be acceptable in Spain. The 10-year incremental cost per incontinence episode avoided for SNM also makes this therapy the dominant option compared to BoNT-A or OMT. Additionally, the estimated budget impact of the gradually increased referral for SNM for the management of OAB patients in Spain is small. CONCLUSIONS: As a treatment option for refractory idiopathic OAB, at 10 years, SNM provides a considerable possibility of symptom and quality-of-life improvement and is cost-effective compared to BoNT-A or continued OMT.

Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe.

BACKGROUND: Silodosin is a new selective therapy with a high pharmacologic selectivity for the α(1A)-adrenoreceptor. OBJECTIVE: Our aim was to test silodosin's superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound silodosin. DESIGN, SETTING, AND PARTICIPANTS: We conducted a multicenter double-blind, placebo- and active-controlled parallel group study. A total of 1228 men ≥50 yr of age with an International Prostate Symptom Score (IPSS) ≥13 and a urine maximum flow rate (Q(max)) >4 and ≤15 ml/s were selected at 72 sites in 11 European countries. The patients were entered into a 2-wk wash-out and a 4-wk placebo run-in period. A total of 955 patients were randomized (2:2:1) to silodosin 8 mg (n=381), tamsulosin 0.4 mg (n=384), or placebo (n=190) once daily for 12 wk. MEASUREMENTS: We calculated the change from baseline in IPSS total score (primary), storage and voiding subscores, quality of life (QoL) due to urinary symptoms, and Q(max). Responders were defined on the basis of IPSS and Q(max) by a decrease of ≥25% and an increase of ≥30% from baseline, respectively. RESULTS AND LIMITATIONS: The change from baseline in the IPSS total score with silodosin and tamsulosin was significantly superior to that with placebo (p<0.001): difference active placebo of -2.3 (95% confidence interval [CI], -3.2, -1.4) with silodosin and -2.0 (95% CI,-2.9, -1.1) with tamsulosin. Responder rates according to total IPSS were significantly higher (p<0.001) with silodosin (66.8%) and tamsulosin (65.4%) than with placebo (50.8%). Active treatments were also superior to placebo in the IPSS storage and voiding subscore analyses, as well as in QoL due to urinary symptoms. Of note, only silodosin significantly reduced nocturia versus placebo (the change from baseline was -0.9, -0.8, and -0.7 for silodosin, tamsulosin, and placebo, respectively; p=0.013 for silodosin vs placebo). An increase in Q(max) was observed in all groups. The adjusted mean change from baseline to end point was 3.77 ml/s for silodosin, 3.53 ml/s for tamsulosin, and 2.93 ml/s for placebo, but the change for silodosin and tamsulosin was not statistically significant versus placebo because of a particularly high placebo response (silodosin vs placebo: p=0.089; tamsulosin vs placebo: p=0.221). At end point, the percentage of responders by Q(max) was 46.6%, 46.5%, and 40.5% in the silodosin, tamsulosin, and placebo treatment groups, respectively. This difference was not statistically significantly (p=0.155 silodosin vs placebo and p=0.141 tamsulosin vs placebo). Active treatments were well tolerated, and discontinuation rates due to adverse events were low in all groups (2.1%, 1.0%, and 1.6% with silodosin, tamsulosin, and placebo, respectively). The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm (14%), a reversible effect as a consequence of the potent and selective α(1A)-adrenoreceptor antagonism of the drug. The incidence was higher than that observed with tamsulosin (2%); however, only 1.3% of silodosin-treated patients discontinued treatment due to this adverse event. CONCLUSIONS: Silodosin is an effective and well-tolerated treatment for the relief of both voiding and storage symptoms in patients with lower urinary tract symptoms suggestive of bladder outlet obstruction thought to be associated with benign prostatic hyperplasia. Its overall efficacy is not inferior to tamsulosin. Only silodosin showed a significant effect on nocturia over placebo. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00359905.

[Vesicoureteral reflux in adults]. / Reflujo vesicoureteral en el adulto.

Primary vesicoureteral reflux is defined as the dysfunction of the vesicoureteral junction in the absence of any other bladder pathology. Most works in the literature focus on pediatric vesicoureteral reflux, paying little attention to reflux in adults. There is not much knowledge about the real incidence of this pathology in adults and there are few published papers about what are the situations in which we should suspect, perform a diagnostic work up and treat reflux in adult patients. It is article we perform a bibliographic review on topics as important as epidemiology, diagnosis and treatment of reflux in adults. The objective of this article is to transmit what are the clinical manifestations in front of which we should look for adult reflux and when to treat when it is diagnosed.

Reflujo vesicoureteral en el adulto / Vesicoureteral reflux in adults

El reflujo vesicoureteral primario se define como la disfunción de la unión vesicoureteral en ausencia de otra patología vesical subyacente. La mayoría de la literatura aborda el reflujo vesicoureteral en la infancia, prestando poca atención al reflujo del adulto. Poco se sabe sobre la incidencia real de esta patología en adultos y poco se ha publicado sobre en que situaciones debemos sospechar, buscar y tratar un reflujo en adultos. En este capítulo se ha hecho una revisión de la literatura sobre cuestiones tan importantes como la epidemiología, diagnóstico y tratamiento del reflujo en adultos. El objetivo de este artículo es trasmitir ante que manifestaciones clínicas debemos buscar un reflujo del adulto y si este es diagnosticada cuando debe ser tratado (AU)

Primary vesicoureteral reflux is defined as the dysfunction of the vesicoureteral junction in the absence of any other bladder pathology. Most works in the literature focus on pediatric vesicoureteral reflux, paying little attention to reflux in adults. There is not much knowledge about the real incidence of this pathology in adults and there are few published papers about what are the situations in which we should suspect, perform a diagnostic work up and treat reflux in adult patients. It is article we perform a bibliographic review on topics as important as epidemiology, diagnosis and treatment of reflux in adults. The objective of this article is to transmit what are the clinical manifestations in front of which we should look for adult reflux and when to treat when it is diagnosed (AU)

Nestin, a neuroectodermal stem cell marker molecule, is expressed in Leydig cells of the human testis and in some specific cell types from human testicular tumours.

The intermediate filament protein nestin is predominantly expressed in some stem/progenitor cells and appears to be a useful molecular tool to characterise tumours originating from precursor cells of neuroectodermal and mesenchymal lineages. Leydig cells originate in the adult testis by differentiation from stem cells and express a variety of neural and neuroendocrine markers. The possible expression of the neural stem cell marker nestin in Leydig cells and testicular tumour cells was determined by analysing the patterns of nestin expression in normal and pathological human testes by Western blot and immunohistochemical methods. In normal testis, nestin was found in some vascular endothelial cells, a subset of peritubular spindle-shaped cells and some Leydig cells; spermatogenic and Sertoli cells were unstained. In normal Leydig cells, nestin was distributed in the perinuclear cytoplasm and accumulated in the crystalloids of Reinke with ageing. In non-tumour pathologies (cryptorchidism, impaired spermatogenesis), the seminiferous tubules were immunonegative, whereas hyperplastic Leydig cells showed cytoplasmic immunolabelling. In testicular malignancies, nestin was localised in the Sertoli cells of the seminiferous tubules affected with intratubular germ cell neoplasia, in the hyperplastic Leydig cells associated with these tumours and in some components (mesenchymal and neuroepithelial cells) of teratomas; spermatocytic and non-spermatocytic seminomas were unstained. Some vascular endothelial cells were immunolabelled in all tumour samples. Thus, nestin is expressed in a population of normal and hyperplastic Leydig cells and in Sertoli cells in the presence of intratubular germ-cell neoplasia. Nestin may be a good marker for identifying components of testicular teratomas.

[AMS-800 artificial sphincter. Our experience in the last 20 years]. / Esfinter artificial AMS-800. Nuestra experiencia en los últimos 20 años.

OBJECTIVE: To present a series of 63 patients with urinary incontinence due to sphincteric incompetence who underwent the implantation of an AMS-800 artificial sphincter. METHODS: From 1984 to December 2002 a total of 69 patients received this prosthesis, 63 of which were available for review. The cause of incontinence was sphincter incompetence in all cases, said secondary to prostate surgery, neurogenic bladder, post-traumatic urethral lesion, and epispadias. 52 of them were placed in the bulbar urethra, and 11 in the bladder neck. The cuff diameters varied from 4 to 10 cm and reservoir pressures from 51-60 to 71-18 H2O cm. RESULTS: The complications that appeared, ordered by frequency, were: malfunction, infection and rejection or exteriorization, fistula, and unappropriate size. The total number of reoperations was 39 in 28 patients. Functional results were successful in 48 cases and failure in 15. CONCLUSIONS: The use of an AMS-800 prosthesis for the treatment of urinary incontinence due to sphincteric incompetence is effective but not without complications. The most frequent indication was following prostate surgery, being this group the one that obtains the best results. Patients with incontinence of neurogenic origin have the highest complication rate, and the worst results in relation to vascularization and tissue trophism abnormalities. In female patients we prefer other techniques that have similar results, are technically easier and more economic.

Esfínter artificial AMS-800. Nuestra experiencia en los últimos 20 años / AMS-800 artificial sphincter. Our experience over the last 20 years

OBJETIVO: Presentar una serie de 63 pacientes con incontinencia urinaria por incompetencia esfinteriana que han sido tratados mediante la implantación del esfínter artificial AMS-800. MÉTODOS: Desde 1984 hasta diciembre del año 2002 se ha implantado esta prótesis a un total de 69 pacientes de los cuales se ha podido revisar a 63. La causa de la incontinencia siempre ha sido incompetencia esfinteriana secundaria a cirugía prostática, vejiga neurógena, lesión uretral postraumática y epispadias. De ellos 52 se han colocado en uretra bulbar y 11 en cuello, los tamaños del manguito han variado entre 4 y 10 centímetros y las presiones del reservorio de 51-60 a 71-80 centímetros de agua. RESULTADOS: Las complicaciones detectadas fueron por orden de frecuencia: mal funcionamiento, infección y rechazo o exteriorización, fístula y tamaño no adecuado. El número total de reintervenciones fue de 39, en 28 pacientes. El resultado funcional fue de éxito en 48 y fracaso en 15. CONCLUSÌÓN: El uso de la prótesis AMS-800 para el tratamiento de la incontinencia por incompetencia esfinteriana es eficaz pero no exento de complicaciones. La indicación más frecuente es tras cirugía prostática, siendo en este grupo donde se obtienen los mejores resultados. En pacientes con incontinencia de origen neurógeno la tasa de complicaciones es mayor y los resultados peores dadas las alteraciones de la vascularización y trofismo tisular. En mujeres preferimos la utilización de otras técnicas con las que se obtienen resultados similares, técnicamente más sencillas y más económicas (AU)

[Therapeutic advantages of rigid transurethral ureteroscopy in ureteral lithiasic pathology: retrospective study of 735 cases]. / Ventajas terapéuticas de la ureteroscopia transuretral rígida en la patología litiásica ureteral: estudio retrospectivo de 735 casos.

OBJECTIVE: To present the results achieved by rigid transurethral ureteroscopy for the management of ureteral calculi over a period of 10 years. METHODS: From January 1991 to November 2000, 735 rigid transurethral ureteroscopy procedures for ureteral calculi were performed in our Lithotripsy Unit. The rigid ureteroscopes utilized ranged from 9.5-11.5 F. There was a higher prevalence of male patients (63%). The mean age was 49.9 years. Calculi were more frequently localized in the pelvic ureter (74.2%). The mean maximum diameter of the calculi was 9.6 mm and caused moderate to severe uropathy in 78.6% of the cases and functional impairment in 3.7% of the cases. After performing ureteroscopy, a double-J catheter was left indwelling in 65.8% of the patients. The patients were discharged from hospital usually 12-18 h after the endoscopic procedure. RESULTS: Of the 735 ureteroscopies performed, satisfactory results were achieved in 676 cases (92%); stone resolution was not achieved in 59 cases. For complete resolution of the calculi, mechanical or electrokinetic fragmentation was used in a high proportion of patients (56.3%). Removal of the stone or stone fragments was mainly by forceps (79.7%); the Dormia basket was used in 18.2% of the cases. The complications occurred during or immediately after the procedure and were minor (10.7%), although there were 3 patients with major complications (2 ureteral eversion and one case of ureteral avulsion). CONCLUSIONS: In our view, rigid transurethral ureteroscopy is a useful, safe and efficient technique in the treatment of calculi in the pelvic ureter, and in selected cases of calculi in the sacral or lumbar level, after failed ESWL. Rigid transurethral ureteroscopy achieves excellent resolution and the complications are scanty.

Ventajas terapéuticas de la ureteroscopia transuretral rígida en la patología litiásica ureteral: estudio retrospectivo de 735 casos / Therapeutic advantages of rigid transurethral ureteroscopy for uretral calculi: Review of 735 cases

Objetivo: Presentar los resultados obtenidos tras realizar ureteroscopias transuretrales rígidas durante un periodo de 10 años. Métodos: Desde Enero de 1991 a Noviembre de 2000 se han realizado en nuestra Unidad de Litotricia 735 ureteroscopias rígidas vía transuretral para la resolución de litiasis ureteral. Los ureteroscopios rígidos utilizados fueron de calibre variable, oscilando entre el 9.5 y 11.5 Ch. Entre los pacientes a los que se efectuó la ureteroscopia había un predominio de varones (63 por ciento de los casos), siendo la media de edad de los pacientes 49.9 años. La localización de la litiasis ureteral más frecuente fue a nivel pelviano (74.2 por ciento de los casos), siendo la media del diámetro mayor de los cálculos de 9.6 milímetros, ocasionando el mismo una uropatía moderada-severa en el 78.6 por ciento de los casos y anulación funcional en el 3.7 por ciento de los casos. Tras realizar ureteroscopia se dejó catéter doble J en el 65.8 por ciento de los pacientes. El alta hospitalaria habitualmente es precoz (12-18 horas del procedimiento endoscópico).Resultados: De las 735 ureteroscopias realizadas se consiguió un resultado satisfactorio en 676 casos (92 por ciento de los pacientes), siendo imposible de solucionar la patología litiásica en 59 casos. Para la resolución completa de los cálculos se utilizó fragmentación -ultrasónica o electrocinética- en una alto porcentaje de pacientes (56.3 por ciento). La forma de extracción de los cálculos o fragmentos se hizo fundamentalmente mediante pinzas (79.7 por ciento de los casos), pero también mediante Dormia (18.2 por ciento de los casos). Las complicaciones que hemos valorado han sido las producidas en el mismo acto quirúrgico o inmediatas, siendo éstas fundamentalmente menores (10.7 por ciento de los pacientes), pero también hemos tenido complicaciones mayores en 3 ocasiones (dos eversiones ureterales y una avulsión ureteral).Conclusiones: Consideramos que la ureteroscopia rígida por vía transuretral es una técnica útil, segura y eficaz en el tratamiento de los cálculos localizados en el uréter pelviano, pero también en casos seleccionados a nivel sacro y lumbar, donde no ha sido eficaz el tratamiento con ESWL, debido a los excelentes resultados obtenidos y a las pocas complicaciones existentes (AU)

Carcinoma epidermoide de escroto / Epidermoid carcinoma of the scrotum

OBJETIVO: Analizar el enfoque terapéutico del carcinoma epidermoide de escroto o carcinoma de células escamosas, lesión neoplásica de muy baja incidencia, y de especial interés tanto por razones clínicas como históricas. MÉTODO Y RESULTADO: Presentamos el caso de un paciente diagnosticado de carcinoma epidermoide escrotal y al que se le realizó uretroplastia, según técnica de Ben Johanson, hace 25 años (1972), con injerto libre de piel prepucial. Al paciente se le practicó escrotectomía más orquiectomía derechas y uretrectomía parcial con linfadenectomía inguinal diferida seis semanas. La evolución fue satisfactoria sin recidiva de la lesión a los 24 meses. CONCLUSIONES: Las neoplasias malignas de escroto son una entidad de muy baja incidencia, siendo el carcinoma de células escamosas, el más frecuente. El tratamiento de elección es la cirugía radical más linfadenectomía inguinal. Es imprescindible realizar el diagnóstico diferencial con el carcinoma epidermoide verrucoso, de enfoque terapéutico diferente y donde la cirugía radical no está indicada (AU)

Actividad telomerasa como marcador en el tumor superficial de vejiga / Telomerase activity: a marker of superficial bladder cancer

OBJETIVOS: Determinar la actividad de la enzima telomerasa en la orina de pacientes diagnosticados de tumor superficial de vejiga para valorar su sensibilidad y especificidad como marcador tumoral y sus posibles implicaciones de pronóstico, diagnóstico y eficacia terapéutica. MÉTODOS: Se estudiaron las muestras de orina de 50 pacientes diagnosticados de tumor vesical superficial. La actividad telomerasa se determinó mediante la técnica TRAP (telomeric repit amplification protocol). Se determinó citología urinaria estándar, cultivo de orina y estudio del sedimento urinario. El estudio se completó con el informe anatomopatológico del tumor resecado. RESULTADOS: Se encontró actividad telomerasa positiva en el 84 por ciento del total de pacientes, encontrando citología positiva sólo en el 52 por ciento de los mismos. La sensibilidad y especificidad fueron del 73,6 por ciento y 92,7 por ciento respectivamente, siendo para la citología urinaria, en nuestro estudio, del 53,2 por ciento y 81,8 por ciento. El grado de diferenciación celular y en menor medida el grado de infiltración de la pared vesical, marcaron diferencias respecto a la citología urinaria convencional. CONCLUSIONES: La actividad telomerasa se puede determinar en orina de pacientes diagnosticados de tumor vesical con una sensibilidad y especificidad mayor que la citología estándar, representando un buen marcador para el diagnóstico y seguimiento de estos pacientes (AU)