Recomendaciones sobre el uso de las instilaciones endovesicales de ácido hialurónico en el síndrome de dolor vesical / Recommendations on the use of intravesical hyaluronic acid instillations in bladder pain syndrome

Introducción El síndrome del dolor vesical (SDV) es un síndrome complejo, sin etiología claramente establecida, que engloba diferentes entidades como la cistitis intersticial. Esto conlleva dificultades para establecer una definición precisa, obtener datos de prevalencia exactos y definir criterios diagnósticos y métodos estandarizados de estudio. Tampoco existe homogeneidad sobre el tratamiento del SDV. Las instilaciones endovesicales con ácido hialurónico (AH) son una opción, sin aún recomendaciones específicas.Objetivo Sintetizar la evidencia científica sobre las opciones terapéuticas disponibles para el SDV y consensuar un plan de trabajo y unas recomendaciones para el uso de las instilaciones endovesicales con AH.La Asociación Española de Urología, a través del Grupo de Urología Funcional, Femenina y Urodinámica, generó una comisión de expertos. Esta comisión fue la encarga de revisar la literatura (evidencia), consensuar el plan de trabajo y proponer recomendaciones.ResultadosExiste una gran variabilidad en la literatura sobre el tratamiento del SDV, sin un régimen estándar de instilación endovesical con AH (frecuencia y duración del tratamiento de inicio y mantenimiento).Conclusiones Las instilaciones endovesicales de AH (dosis habitual de 40mg) son efectivas y seguras. Pueden combinarse con otras opciones, siendo aún necesario comprobar la eficacia en algunos casos. El tratamiento se divide en varias sesiones iniciales semanales, seguidas de tratamiento de mantenimiento, generalmente mensual (duración de los ciclos no establecida).Se consensuaron recomendaciones sobre el manejo del SVD, con criterios diagnóstico y pautas para el tratamiento con AH endovesical (inicio, reevaluación y seguimiento) (AU)

Introduction Bladder pain syndrome (BPS) is a complex syndrome, without a clearly defined etiology that encompasses different entities, such as interstitial cystitis. This leads to difficulties in establishing a precise definition, obtaining accurate prevalence data, and defining diagnostic criteria and standardized assessment methods. Moreover, there is no consensus regarding the treatment of BPS. Intravesical instillations with hyaluronic acid (HA) are an option, although no specific recommendations have been made yet.Objective To synthesize the scientific evidence on the therapeutic options available for BPS and to establish a work plan and recommendations for the use of intravesical instillations with HA.The Spanish Association of Urology, through the Functional, Female, and Urodynamic Urology Group, created a commission of experts. This commission was in charge of reviewing literature (evidence), agreeing on the work plan, and proposing recommendations.ResultsThere is great variability in literature on the treatment of BPS, without a standard regimen of intravesical instillation with HA (frequency and duration of initial and maintenance treatment).Conclusions Intravesical HA instillations (usual dose of 40 mg) are effective and safe. They can be combined with other options, with efficacy still to be determined in some cases. Treatment is divided into several initial weekly sessions, followed by maintenance treatment, usually monthly (unestablished duration of cycles).Recommendations on the management of BPS were agreed, with diagnostic criteria and guidelines for treatment with intravesical HA (initiation, reassessment, and follow-up) (AU)

Recommendations on the use of intravesical hyaluronic acid instillations in bladder pain syndrome.

INTRODUCTION: Bladder pain syndrome (BPS) is a complex syndrome, without a clearly defined etiology that encompasses different entities, such as interstitial cystitis. This leads to difficulties in establishing a precise definition, obtaining accurate prevalence data, and defining diagnostic criteria and standardized assessment methods. Moreover, there is no consensus regarding the treatment of BPS. Intravesical instillations with hyaluronic acid (HA) are an option, although no specific recommendations have been made yet. OBJECTIVE: To synthesize the scientific evidence on the therapeutic options available for BPS and to establish a work plan and recommendations for the use of intravesical instillations with HA. The Spanish Association of Urology, through the Functional, Female, and Urodynamic Urology Group, created a commission of experts. This commission was in charge of reviewing literature (evidence), agreeing on the work plan, and proposing recommendations. RESULTS: There is great variability in literature on the treatment of BPS, without a standard regimen of intravesical instillation with HA (frequency and duration of initial and maintenance treatment). CONCLUSIONS: Intravesical HA instillations (usual dose of 40 mg) are effective and safe. They can be combined with other options, with efficacy still to be determined in some cases. Treatment is divided into several initial weekly sessions, followed by maintenance treatment, usually monthly (unestablished duration of cycles). Recommendations on the management of BPS were agreed, with diagnostic criteria and guidelines for treatment with intravesical HA (initiation, reassessment, and follow-up).

Resultados de la subpoblación española del estudio BELIEVE. Evaluación de la calidad de vida y persistencia al tratamiento de pacientes tratados con mirabegrón / Quality of life and treatment persistence evaluation in Spanish patients treated with mirabegron. Results of the BELIEVE study

INTRODUCCIÓN Y OBJETIVO: El estudio BELIEVE es un estudio europeo, no intervencionista, con pacientes con vejiga hiperactiva que recibieron mirabegrón en condiciones de práctica clínica habitual. El presente estudio incluye datos de la subpoblación española, y evalúa su calidad de vida relacionada con la salud (CVRS) y su persistencia al tratamiento. MATERIALES Y MÉTODOS: Se analizaron los datos de los 11 centros españoles del estudio BELIEVE. La variable principal fue el cambio de la CVRS desde el estado basal, a partir del cuestionario OAB-q. Las variables secundarias incluyeron la persistencia al tratamiento, la CVRS mediante el EQ-5D-5L y los acontecimientos adversos. El periodo de seguimiento fue de 12 meses, con 2 ventanas a los 2-4 meses y a los 10-12 meses. RESULTADOS: Se incluyeron 153 pacientes españoles. En el Full Analysis Set (FAS), el 63,1% eran mujeres, con una edad media de 66 años. Las puntuaciones de la molestia de síntomas y la CVRS total mostraron una mejora hasta los 2-4 meses y los 10-12 meses. El EQ-5D-5L también mostró una mejora en la CVRS de estos pacientes. La persistencia fue elevada, ya que el 49% de los pacientes seguían recibiendo mirabegrón a los 10-12 meses. No se observaron problemas de seguridad inesperados y los acontecimientos adversos coincidieron con el perfil de seguridad conocido de mirabegrón. CONCLUSIONES: Los pacientes españoles que reciben mirabegrón en condiciones de práctica clínica real reportan mejoras en su CVRS, con una buena tolerabilidad y una persistencia aceptable al tratamiento

INTRODUCTION AND OBJECTIVE: The BELIEVE study is a European, non-interventional study which includes patients with overactive bladder who were prescribed mirabegron as part of routine clinical practice. Data from the Spanish subpopulation has been obtained for the present study, aiming to analyze health-related quality-of-life (HRQoL) and treatment persistence of these patients. MATERIALS AND METHODS: Data from 11 Spanish hospitals of the BELIEVE study were analyzed. The primary endpoint was to evaluate change of HRQoL from baseline with overactive bladder questionnaire (OAB-q). Secondary endpoints included treatment persistence, HRQoL based on the EQ-5D-5L questionnaire and adverse events. Study follow-up was 12 months, with two visit windows at 2-4 months and 10-12 months. RESULTS: 153 Spanish patients were enrolled in the study. In the Full Analysis Set (FAS), 63.1% were women, and the mean age was 66 years. Symptom bother and HRQoL improved from baseline to 2-4 months and 10-12 months. EQ-5D-5L questionnaire also showed an improved patients' HRQoL. Treatment persistence was high, as 49% of patients remained with mirabegron at 10-12 months. Adverse events were consistent with previous safety profile results of mirabegron, and no unexpected safety issues were observed. CONCLUSIONS: Spanish patients treated with mirabegron in real clinical practice reported improvements in HRQoL, with a good tolerability and persistence to treatment

Quality of life and treatment persistence evaluation in Spanish patients treated with mirabegron. Results of the BELIEVE study. / Resultados de la subpoblación española del estudio BELIEVE. Evaluación de la calidad de vida y persistencia al tratamiento de pacientes tratados con mirabegrón.

INTRODUCTION AND OBJECTIVE: The BELIEVE study is a European, non-interventional study which includes patients with overactive bladder who were prescribed mirabegron as part of routine clinical practice. Data from the Spanish subpopulation has been obtained for the present study, aiming to analyze health-related quality-of-life (HRQoL) and treatment persistence of these patients. MATERIALS AND METHODS: Data from 11 Spanish hospitals of the BELIEVE study were analyzed. The primary endpoint was to evaluate change of HRQoL from baseline with overactive bladder questionnaire (OAB-q). Secondary endpoints included treatment persistence, HRQoL based on the EQ-5D-5L questionnaire and adverse events. Study follow-up was 12 months, with two visit windows at 2-4 months and 10-12 months. RESULTS: 153 Spanish patients were enrolled in the study. In the Full Analysis Set (FAS), 63.1% were women, and the mean age was 66 years. Symptom bother and HRQoL improved from baseline to 2-4 months and 10-12 months. EQ-5D-5L questionnaire also showed an improved patients' HRQoL. Treatment persistence was high, as 49% of patients remained with mirabegron at 10-12 months. Adverse events were consistent with previous safety profile results of mirabegron, and no unexpected safety issues were observed. CONCLUSIONS: Spanish patients treated with mirabegron in real clinical practice reported improvements in HRQoL, with a good tolerability and persistence to treatment.

Evaluación de la función cognitiva en pacientes de edad avanzada con vejiga hiperactiva tratados con oxibutinina transdémica / Cognitive function assessment in elderly patients with overactive bladder treated with transdermal oxybutynin

Introducción y objetivos: Los pacientes mayores con vejiga hiperactiva bajo tratamiento antimuscarínico son especialmente susceptibles al deterioro cognitivo. El objetivo fue evaluar los cambios a corto plazo en la función cognitiva de pacientes de edad avanzada con vejiga hiperactiva tratados con oxibutinina transdérmica. Materiales y métodos: Estudio observacional retrospectivo multicéntrico en pacientes entre 65 y 80 años de edad, con vejiga hiperactiva, que reciben tratamiento con oxibutinina transdérmica. Antes y después de un mes de tratamiento, se evaluó la función cognitiva mediante el test de alteración de memoria y el test del dibujo del reloj, los cambios en los síntomas con cuestionarios validados, la percepción del paciente ante su respuesta al tratamiento utilizando la escala de beneficio del tratamiento y la adherencia al tratamiento con el test de Morisky-Green modificado. Resultados: De 85 pacientes elegibles, 70 completaron la evaluación (promedio de edad: 71,4 ± 4,5; IMC: 28,7 ± 3,1 kg/m2). No se observó deterioro cognitivo tras un mes de tratamiento con oxibutinina transdérmica: Test de alteración de memoria (+1 punto; IC 95%: 0-1,5), test del dibujo del reloj (0 puntos; IC 95%: 0-0). Se observó una mejoría estadísticamente significativa (p < 0,001) en todos los síntomas de almacenamiento urinario, excepto en la incontinencia de esfuerzo. Hubo una mejora en el cuestionario de autoevaluación de control de la vejiga (grado de los síntomas: -2,27; IC 95%: -2,8, -1,7; p < 0,001; grado de molestias: -2,73; IC 95%: -3,3, -2,1; p < 0,001). El 70% de los pacientes informaron una condición de vejiga estable o mejorada según el cuestionario de Percepción de la Condición de la Vejiga del Paciente. El 72,8% de los pacientes informó que sus problemas urinarios habían mejorado o mejorado notablemente con un 84,3% de adherencia al tratamiento. Conclusiones: No se observó deterioro cognitivo en pacientes de edad avanzada tras de un mes de tratamiento con oxibutinina transdérmica. Los síntomas de incontinencia urinaria mejoraron y hubo una adecuada adherencia al tratamiento

Introduction and objectives: Older patients with overactive bladder under antimuscarinic treatment are especially susceptible to cognitive impairment. The aim was to assess short term changes in cognitive function in elderly patients with overactive bladder treated with transdermal oxybutynin. Materials and methods: Observational, retrospective, multicentre study in patients with overactive bladder aged 65-80 years undergoing treatment with transdermal oxybutynin. Before and after one month of treatment, cognitive function using the Memory Alteration Test and Clock-Drawing Test, changes in symptoms with validated questionnaires, patient perception of treatment response using Treatment Benefit Scale and treatment adherence with the modified Morisky-Green test, were assessed. Results: From 85 eligible patients, 70 completed the assessment (mean age: 71.4 ± 4.5; BMI: 28.7 ± 3.1 kg/m2). No cognitive impairment was observed after one month with transdermal oxybutynin: Memory Alteration Test (+1 point; 95%CI: 0.0-1.5), Clock-Drawing Test (0 points; 95%CI: 0.0-0.0). A statistically significant improvement (p < 0.001) was observed in all urinary storage symptoms, except stress urinary incontinence. There was an improvement in the Bladder Control Self-Assessment Questionnaire (symptom score: -2.27; 95%CI: -2.8, -1.7; p < 0.001; bother score: -2.73; 95%CI: -3.3, -2.1; p < 0.001). 70% of patients reported either a stable or improved bladder condition according to the Patient Perception of Bladder Condition questionnaire. 72.8% of patients reported that their urinary problems had improved or greatly improved with an 84.3% treatment adherence. Conclusions: No cognitive impairment was observed in elderly patients after one month of treatment with transdermal oxybutynin; urinary urgency symptoms improved and there was adequate treatment adherence

Síndrome de dolor vesical: prevalencia y práctica clínica habitual en mujeres que acuden a Unidades de Urología Funcional y Urodinámica en España / Bladder pain syndrome: Prevalence and routine clinical practice in women attending functional urology and urodynamics units in Spain

Introducción y objetivos: El síndrome de dolor vesical (SDV) está catologado como enfermedad rara y su diagnóstico representa un desafío debido al solapamiento de sus síntomas con los asociados al síndrome de vejiga hiperactiva. El objetivo fue estimar la prevalencia del SDV y conocer el perfil de síntomas y la práctica clínica en pacientes que acuden a unidades de Urología Funcional y Urodinámica. Material y métodos: Estudio epidemiológico en el cual participaron 37 unidades de Urología Funcional y Urodinámica de España. La prevalencia se estudió considerando ambos sexos. Se evaluó la práctica clínica en 319 mujeres con SDV (nuevo diagnóstico o en revisión). Se recogieron retrospectivamente datos clínicos y sociodemográficos. Se analizaron los resultados de análisis de orina, cistoscopia, biopsia, exploración física, diario miccional, así como de los 4 cuestionarios disponibles: Patient Perception of Bladder Condition; Bladder Pain/Interstitial Cystitis Symptom Score; EuroQoL-5 Dimensions-5L y Patient Global Impression of Severity. Resultados: El 5,4% (503) de los pacientes que acudieron a estas unidades (9.312) tenían diagnóstico de SDV (90% [453] mujeres). Las pruebas más realizadas según historia clínica y anamnesis fueron: análisis de orina, ecografía vesical y cistoscopia. Los síntomas/comorbilidades más frecuentes fueron: dolor en la región vesical, frecuencia miccional aumentada, nicturia, ansiedad y depresión. La evaluación diagnóstica determinó dolor en hidrodistensión (86,9%), biopsia positiva (59,2%), dolor miofascial pélvico (28,4%), fenotipo urológico (97,8%) y frecuencia miccional aumentada (88,7%). Los cuestionarios reflejaron el elevado grado de afectación de la calidad de vida de estos pacientes. Conclusiones: La prevalencia del SDV en las unidades de Urología Funcional y Urodinámica en España es baja. No se observa homogeneidad en cuanto al diagnóstico entre los diferentes centros participantes. Por ello, sería necesario establecer una metodología común de manejo de pacientes con SDV en estas unidades, con herramientas específicas para esta patología

Introduction and objectives: Bladder pain syndrome (BPS) is classified as a rare chronic debilitating disease and its diagnosis presents a challenge because its symptoms overlap with those associated with overactive bladder syndrome. The aim of the routine study was to estimate the prevalence of BPS and discover to study the profile of symptoms and clinical practice for patients attending functional urology and urodynamics units. Material and methods: An epidemiological study in which 37 functional urology and urodynamics units in Spain participated. The prevalence was studied in both sexes. Clinical practice was evaluated for 319 women with BPS (new diagnosis or under review). Clinical and sociodemographic data were collected retrospectively. The results were studied of urine tests, cystoscopy, biopsy, physical examination, bladder diary, and those of the four available questionnaires: Patient Perception of Bladder Condition; Bladder Pain/Interstitial Cystitis Symptom Score; EuroQoL-5 Dimensions-5L and Patient Global Impression of Severity. Results: Five point four percent (503) of the patients who attended these units (9,312) had a diagnosis of BPS (90% [453] females). The tests that were performed most according to the clinical history and anamnesis were: urine test, bladder ultrasound and cystoscopy. The most common symptoms/comorbidities were: pain in the bladder region, increased urinary frequency, nocturia, anxiety and depression. Diagnostic assessment determined pain on hydrodistension (86.9%), positive biopsy (59.2%), myofascial pelvic pain (28.4%), urological phenotype (97.8%), and increased urinary frequency (88.7%). The questionnaires reflected how much the quality of life of these patients was affected. Conclusions: The prevalence of BPS in functional urology and urodynamics units in Spain is low. No homogeneity was observed in terms of diagnosis between the different participating centres. Therefore, a common methodology is required for the management of patients with BPS in these units, with tools specific to this disorder

Cognitive function assessment in elderly patients with overactive bladder treated with transdermal oxybutynin. / Evaluación de la función cognitiva en pacientes de edad avanzada con vejiga hiperactiva tratados con oxibutinina transdémica.

INTRODUCTION AND OBJECTIVES: Older patients with overactive bladder under antimuscarinic treatment are especially susceptible to cognitive impairment. The aim was to assess short term changes in cognitive function in elderly patients with overactive bladder treated with transdermal oxybutynin. MATERIALS AND METHODS: Observational, retrospective, multicentre study in patients with overactive bladder aged 65-80 years undergoing treatment with transdermal oxybutynin. Before and after one month of treatment, cognitive function using the Memory Alteration Test and Clock-Drawing Test, changes in symptoms with validated questionnaires, patient perception of treatment response using Treatment Benefit Scale and treatment adherence with the modified Morisky-Green test, were assessed. RESULTS: From 85 eligible patients, 70 completed the assessment (mean age: 71.4±4.5; BMI: 28.7±3.1kg/m2). No cognitive impairment was observed after one month with transdermal oxybutynin: Memory Alteration Test (+1 point; 95%CI: 0.0-1.5), Clock-Drawing Test (0 points; 95%CI: 0.0-0.0). A statistically significant improvement (P<.001) was observed in all urinary storage symptoms, except stress urinary incontinence. There was an improvement in the Bladder Control Self-Assessment Questionnaire (symptom score: -2.27; 95%CI: -2.8, -1.7; P<.001; bother score: -2.73; 95%CI: -3.3, -2.1; P<.001). 70% of patients reported either a stable or improved bladder condition according to the Patient Perception of Bladder Condition questionnaire. 72.8% of patients reported that their urinary problems had improved or greatly improved with an 84.3% treatment adherence. CONCLUSIONS: No cognitive impairment was observed in elderly patients after one month of treatment with transdermal oxybutynin; urinary urgency symptoms improved and there was adequate treatment adherence.

Bladder pain syndrome: Prevalence and routine clinical practice in women attending functional urology and urodynamics units in Spain. / Síndrome de dolor vesical: prevalencia y práctica clínica habitual en mujeres que acuden a Unidades de Urología Funcional y Urodinámica en España.

INTRODUCTION AND OBJECTIVES: Bladder pain syndrome (BPS) is classified as a rare chronic debilitating disease and its diagnosis presents a challenge because its symptoms overlap with those associated with overactive bladder syndrome. The aim of the routine study was to estimate the prevalence of BPS and discover to study the profile of symptoms and clinical practice for patients attending functional urology and urodynamics units. MATERIAL AND METHODS: An epidemiological study in which 37 functional urology and urodynamics units in Spain participated. The prevalence was studied in both sexes. Clinical practice was evaluated for 319 women with BPS (new diagnosis or under review). Clinical and sociodemographic data were collected retrospectively. The results were studied of urine tests, cystoscopy, biopsy, physical examination, bladder diary, and those of the four available questionnaires: Patient Perception of Bladder Condition; Bladder Pain/Interstitial Cystitis Symptom Score; EuroQoL-5 Dimensions-5L and Patient Global Impression of Severity. RESULTS: Five point four percent (503) of the patients who attended these units (9,312) had a diagnosis of BPS (90% [453] females). The tests that were performed most according to the clinical history and anamnesis were: urine test, bladder ultrasound and cystoscopy. The most common symptoms/comorbidities were: pain in the bladder region, increased urinary frequency, nocturia, anxiety and depression. Diagnostic assessment determined pain on hydrodistension (86.9%), positive biopsy (59.2%), myofascial pelvic pain (28.4%), urological phenotype (97.8%), and increased urinary frequency (88.7%). The questionnaires reflected how much the quality of life of these patients was affected. CONCLUSIONS: The prevalence of BPS in functional urology and urodynamics units in Spain is low. No homogeneity was observed in terms of diagnosis between the different participating centres. Therefore, a common methodology is required for the management of patients with BPS in these units, with tools specific to this disorder.

Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual / Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice

Introducción: La evolución natural del tumor vesical no músculo infiltrante (TVNMI) es la recidiva con elevado porcentaje de progresión. La BCG se ha demostrado eficaz para disminuir estos porcentajes, pero hay pocos estudios comparativos entre cepas. Material y métodos: Registro observacional, prospectivo y multicéntrico, estudiándose 433 pacientes con visita de seguimiento a 12 meses de 961 registrados y evaluado supervivencia libre de enfermedad (SLE), de progresión (SLP) cáncer-específica (SE) y efectos adversos. Se estudiaron las cepas Tice, Russian, Tokyo, Connaught y RIVM. Resultados: Los datos sociodemográficos, antecedentes de TVNMI, comorbilidades, tamaño, número, estadio, grado, CIS asociado y Re-RTU, están bien balanceados. SLE: 85 recidivas (19,6%). La mediana del tiempo de SLE fue 20 meses. Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p = 0,93). SLP: 33 progresiones (7,62%). Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p = 0,69). SE: fallecieron 7 pacientes (1,68%). Al comparar la SE entre las diferentes cepas, no se detectaron diferencias (Log-rank test, p = 0,93). En seguridad, el 33,3% habían presentado algún tipo de efecto adverso, mayoritariamente clínica urinaria baja no ITU < 48h, > 48h y hematuria. Según los Common Toxicity Criteria de la European Organisation for Research and Treatment of Cancer, el 92,7% eran grado 1. No se obtuvieron diferencias estadísticamente significativas relevantes entre cepas. Conclusiones: En este análisis intermedio, el riesgo de recidiva, progresión, muerte específica y seguridad es independiente de la cepa de BCG utilizada

Background: The natural progression of bladder tumours (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette-Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains. Material and methods: An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains. Results: The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced. DFS: There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; P =.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P = .69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P = .93). In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) < 48 h, > 48 h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade 1. There were no statistically significant differences between the strains. Conclusions: In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed

Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice. / Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual.

BACKGROUND: The natural progression of bladder tumours (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette-Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains. MATERIAL AND METHODS: An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains. RESULTS: The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced. DFS: There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) <48h, >48h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade1. There were no statistically significant differences between the strains. CONCLUSIONS: In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed.

Evaluación de las propiedades psicométricas de la versión en español del cuestionario ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) en España / Assessment of the Psychometric Properties of the Spanish Language Version of Questionnaire ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

Objetivos: Evaluar las propiedades psicométricas de la versión en castellano del cuestionario ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS): factibilidad (porcentaje de cumplimentación y efecto suelo y techo), fiabilidad (test-retest), validez convergente (vs. Cuestionario de Autoevaluación del Control de la Vejiga [CACV] y vs. International Prostate Symptom Score [I-PSS]) y validez de criterio (según presencia o no de síntoma). Material y métodos: Estudio observacional, no intervencionista y multicéntrico. Participaron 223 pacientes varones de 18-65 años con síntomas del tracto urinario inferior (STUI), predominantemente de llenado. Los pacientes cumplimentaron el ICIQ-MLUTS (test-retest), el I-PSS y el CACV y refirieron sus síntomas urinarios en visita única, a excepción de un subgrupo de 49 pacientes que lo cumplimentaron 15 días después para evaluar la fiabilidad test-retest. El cuestionario contiene 13 ítems en 2 subescalas: Vaciado (V), de 0-20, e Incontinencia (I), de 0-24. Resultados: Porcentaje de pacientes que responden a todos los ítems: 98,84%. Efecto suelo, 0%, y techo menor de 6% en las 2 subescalas del cuestionario. Fiabilidad test-retest: el coeficiente de correlación intraclase (CCI) osciló entre 0,66 y 0,88, salvo en Retardo. El kappa muestra buen acuerdo, entre 0,60 y 0,81, a excepción de Nicturia. Validez convergente: la correlación (Spearman) entre las puntuaciones de las subescalas del cuestionario y el resto de medidas es estadísticamente significativa (p < 0,01 y p < 0,05). Validez de criterio: diferencias estadísticamente significativas (p < 0,05) entre las puntuaciones en el ICIQ-MLUTS de los pacientes que refieren los síntomas respecto a los que no. Conclusión: El ICIQ-MLUTS versión en español muestra adecuada factibilidad, fiabilidad y validez

Objectives: To evaluate the psychometric properties of the Spanish version of the ICIQ-Male Lower Urinary Tract Symptoms Questionnaire (ICIQ-MLUTS): feasibility (% of completion and ceiling/ground effects), reliability (test-retest), convergent validity (vs. Bladder Control Self-Assessment Questionnaire [BSAQ] and vs. International Prostate Symptom Score [I-PSS]) and criterion validity (according to presence or absence of symptoms). Materials and methods: This was an observational, non-interventionist and multicenter study. 223 male patients with lower urinary tract symptoms (LUTS), predominantly storage symptoms and aged 18-65, took part in the study. Patients completed the ICIQ-MLUTS (test), I-PSS and BSAQ questionnaires and referred their urinary symptoms in a single visit, with the exception of a subgroup composed by 49 patients who completed the questionnaire again 15 days after initial visit to evaluate test-retest reliability. The questionnaire includes 13 items divided in 2 sub-scales: Voiding symptoms (V) from 0 to 20 and Incontinence symptoms (I) from 0 to 24. Results: Percentage of patients who completed all items: 98.84%. Ground effect is 0 and ceiling effect was under 6% in both sub-scales. Test-retest reliability: Intraclass correlation coefficient (ICC) ranged from 0.68 to 0.88, except on Delay. Kappa shows a good agreement, between 0.60 and 0.81, except for Nocturia. Convergent validity: Correlation (Spearman) between the questionnaire sub-scales scores and the rest of measures is statistically significant (p < 0.01 and p < 0.05). Criterion validity: Statistically significant differences (p < 0.05) between scores on ICIQ-MLUTS, from patients who refer experiencing symptoms and those who do not. Conclusion: The Spanish version of the ICIQ-MLUTS questionnaire shows adequate feasibility, reliability and validity

Assessment of the psychometric properties of the Spanish language version of questionnaire ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).

OBJECTIVES: To evaluate the psychometric properties of the Spanish version of the ICIQ-Male Lower Urinary Tract Symptoms Questionnaire (ICIQ-MLUTS): Feasibility (% of completion and ceiling/ground effects), reliability (Test-retest), convergent validity (vs Bladder Control Self-Assessment Questionnaire [BSAQ] and vs International Prostate Symptom Score [I-PSS]) and criterion validity (according to presence or absence of symptoms). MATERIAL AND METHODS: This was an observational, non-interventionist and multicenter study. 223 male patients with lower urinary tract symptoms (LUTS), predominantly storage symptoms and aged 18-65, took part in the study. Patients completed the ICIQ-MLUTS (test), I-PSS and BSAQ questionnaires and referred their urinary symptoms in a single visit, with the exception of a subgroup composed by 49 patients that completed the questionnaire again 15 days after initial visit to evaluate test-retest reliability. The questionnaire includes 13 items divided in 2 sub-scales: Voiding symptoms (V) from 0-20 and Incontinence symptoms (I) from 0-24. RESULTS: Percentage of patients that completed all items: 98.84%. Ground effect is 0 and ceiling effect was under 6% in both sub-scales. Test-retest reliability: Intraclass correlation coefficient (ICC) ranged from 0.68 to 0.88, except on Delay. Kappa shows a good agreement, between 0.60 and 0.81, except for Nocturia. Convergent validity: Correlation (Spearman) between the questionnaire sub-scales scores and the rest of measures is statistically significant (P < .01 and P < .05). Criterion validity: Statistically significant differences (P < .05) between scores on ICIQ-MLUTS, from patients that refer experiencing symptoms and those who do not. CONCLUSION: The Spanish version of the ICIQ-MLUTS questionnaire shows adequate feasibility, reliability and validity.

[Medical treatment of bladder instability. Our experience]. / Tratamiento médico de la inestabilidad vesical. Nuestra experiencia.

OBJECTIVE: To identify the factors that influence response to treatment of vesical instability. METHODS: A retrospective study was conducted to assess the efficacy of drug therapy with oxybutinin and imipramine in 89 patients with urodynamically demonstrated detrusor hyperreactivity. Control evaluations were performed at 2, 5 and 8 months. Evaluation of the results took into account the etiology, pressure and volume at which the wave of instability appeared. RESULTS: The results were evaluated according to patient subjective criteria. We observed a positive response (cure and improvement) to treatment with oxybutinin alone or oxybutinin+imipramine in 66.25% of the cases; side effects were observed in 44%. There was a 20% improvement in the positive response rate when the wave intensity was greater than 55 cm H2O and the bladder volume at which this occurred was greater than 150 ml. No patient treated with second line drug therapy (flavoxate, nifedipine and trospium chloride) cured. CONCLUSIONS: The etiology of vesical instability did not influence response to therapy. Waves with a greater intensity and those that appeared at higher volumes responded better to treatment. Nearly half of the patients with side effects required a reduction of the dosage or withdrawal of the drug. Our results and those reported elsewhere indicate that non-responders to treatment with oxybutinin alone or in combination with imipramine are unlikely to improve with currently available drug therapy.

[Suburethral sling in the treatment of urinary incontinence: our experience]. / Cabestrillo suburetral en el tratamiento de la incontinencia urinaria: nuestra experiencia.

Review of 17 female patients who underwent placing of Suburethral Sling as anti-incontinence procedure with the purpose of assessing the results obtained. The most frequent complications were urinary retention and post-surgical urgency. A larger proportion of patients with Stress Urinary Incontinence had retention and during more days than those with Mixed Urinary Incontinence. In most cases of mixed urinary incontinence, asymptomatic prior to surgery, the placing of a suburethral sling provokes signs and symptoms of urgency, and even of post-surgical urgency-incontinence. Both complications were attenuated in all cases using measures such as conservation of urinary by-pass or administration of anti-cholinergics. Results at 2 years have been successful in 68.75% cases, thus encouraging us to reduce the number of indications for this technique.

[Stenosis of the pyeloureteral junction and contralateral renal carcinoma]. / Estenosis de la unión pieloureteral y carcinoma renal contralateral.

We report a case of advanced ureteropelvic junction obstruction associated with contralateral renal carcinoma in a 39-year-old male patient who consulted for frequent episodes of renal colic and gross asymptomatic hematuria. The results of the renal function tests and the radiological and isotope work up indicated a two-stage surgical procedure of pyeloplasty and contralateral partial nephrectomy. At 6 years follow up the patient is tumor free and renal function is preserved.

[Trigeminal neuralgia. First manifestation of adenocarcinoma of the prostate]. / Neuralgia del trigémino. Primera manifestación de un adenocarcinoma de próstata.

We report a case of adenocarcinoma of the prostate that had been incidentally discovered during patient evaluation for trigeminal nerve neuralgia refractory to treatment. Analysis revealed the underlying cause of neuralgia was tumor metastasis to the mandible, which had caused irritation of the fifth nerve. The patient was treated with complete androgenic block and his symptoms improved simultaneously with partial remission of metastasis.

[The use of computerized tomography in the localization of impalpable testes]. / El uso de la tomografía computarizada en la localización de testículos no palpables.

Computed tomography is the most reliable method in the localization of the impalpable testis. This imaging technique permits precise preoperative localization where ultrasound cannot. Moreover, it can provide very useful information in the complicated cases of cryptorchidism (torsion, trauma, tumor) and can disclose other previously undetected coexisting anomalies.

[The immotile cilia syndrome as a cause of sterility]. / El síndrome del cilio inmóvil como causa de esterilidad.

We investigated the relationship between ciliary dyskinesia--commonly referred to as inmotile cilia syndrome--and sterility. In the past two years, we have accurately diagnosed 6 new cases of a total of 20 suspected as having this condition. To make the diagnosis, complete clinical, radiological, ultrastructural and spermatic work up was performed. All males in the fertile age were found to be sterile with spermatozoides with no motility. Sterility may initially go undetected in these patients due to early intense ORL and respiratory symptoms they present. However, mild forms of this disease entity may be asymptomatic and patients may consult for sterility with a clinical picture of scantily florid chronic bronchitis like that of smokers. Coincidental situs inversus may be useful in making the diagnosis.

[Adriamycin versus ftorafur in the prevention of recurrence of superficial carcinoma of the bladder]. / Adriamicina versus ftorafur como profilaxis de recidiva en el carcinoma vesical superficial.

We performed a randomized prospective study in 40 patients with primary superficial carcinoma of the bladder who had been submitted to TUR. These patients were divided into two groups; one received intravesical adriamycin and the other oral ftorafur. We analyzed tumor size, number and grade and determined the recurrence rate (IR), recurrence rate/month (RR) recurrence rate/cystoscopy (RIC), disease-free interval, survival curves, and drug toxicity. After a mean follow-up of 19.7 months for the patient group that received adriamycin and 20.2 months for the group on oral ftorafur, the IR, RR, and RIC for the group on adriamycin were 40, 2.20 and 0.08%, respectively, and 33.3, 1.64 and 0.07% for the patient group on ftorafur (difference: NS). Drug toxicity was practically absent for the group on adriamycin whereas treatment had to be discontinued in two of the patients on ftorafur due to gastric intolerance. Furthermore, ftorafur was shown to cause a transient increase of transaminase levels in 4 patients, cutaneous changes and alterations in fingernails in 1 patient, and intense dermatitis during the last month of treatment in another patient. However, it was not necessary to discontinue treatment.