Anatomical outcomes and complications of sacrocolpopexy using Surelift Uplift mesh: A multicentric observational study.

OBJECTIVE: The study evaluated the anatomical and functional outcomes, as well as the safety data of laparoscopic sacrocolpopexy (LSC) for pelvic organ prolapse (POP) using a lightweight macroporous mesh. METHODS: A multicentric observational study was developed including five expert centers between March 2011 and December 2019. Inclusion criteria were female patients with symptomatic ≥stage II POP (POP-Q classification), who underwent a LSC. A lightweight and macroporous mesh device (Surelift Uplift) was used. Baseline anatomical positions were evaluated using POP-Q stage. The anatomical outcomes and procedural complications were assessed during the postoperative period. Primary outcomes were anatomical success, defined as POP-Q stage ≤I, and subjective success, defined as no bothersome bulge symptoms, and no repeat surgery or pessary use for recurrent prolapse. RESULTS: A total of 325 LSCs were analyzed with a median patient age of 66 (interquartile range [IQR] 61-73). After a median follow-up of 68 months (IQR 46.5-89), anatomical success was found in 88.9%, whereas subjective success was seen in 98.5% of the patients. Recurrent prolapse presented as cystocele (1.5%). Reported complications were bladder (4.6%) or rectum lesions (0.6%), de novo urinary incontinence (12.9%), and mesh extrusion (1.2%). CONCLUSIONS: LSC provides significant clinical improvement and excellent anatomical results, with a low risk of serious complications for women with ≥2 grade POP in a real clinical practice setting.

Bladder Capacity in Women With Overactive Bladder Syndrome: A Cross-sectional Study.

OBJECTIVE: To evaluate bladder capacity in women with idiopathic overactive bladder syndrome (OAB) through bladder diary, cystomanometry, and uroflowmetry and assess the concordance of the different measures of bladder capacity. A secondary objective is to describe the relationship between bladder capacity and urinary frequency in OAB patients. METHODS: An observational cross-sectional multicentric study was conducted, including female patients diagnosed with idiopathic OAB. All participants underwent a urodynamic study and completed a 3-day bladder diary (3dBD). Different parameters were used to calculate bladder capacity: maximum cystometric capacity (MCC) assessed at the end of filling cystometry, voided volume (VV) during the uroflowmetry, maximum voided volume (VVmax), and average voided volume (VVmed), both assessed through the 3dBD. Reproducibility analysis was performed to assess the agreement among the different bladder capacity measures. Intraclass correlation coefficient (ICC) and weighted Kappa index were used. Bladder capacity parameters were also assessed in relation to urinary frequency. RESULTS: Bladder capacity measures were diminished in this population, except for VVmax. Poor correlation was found between the different bladder capacity variables (ICC and weighted Kappa index <0.4). Twenty-four-hour frequency and average VV present a weak negative linear relationship (Pearson coefficient -0.344). CONCLUSION: MCC and average VV are reduced in OAB patients. MCC does not correlate well with functional bladder volumes determined by voiding diary in the OAB population.

[UPOINT phenotypic classification of a sample of female patients with bladder pain syndrome: Results of a national multicentric observational study.] / Clasificación fenotípica UPOINT de una muestra de mujeres con síndrome de dolor vesical: resultados de un estudio observacional multicéntrico nacional.

OBJECTIVES: To study the possibility of classifying patients with BPS by UPOINT phenotypes and their correlation with the results of different BPS diagnostic tools. MATERIAL AND METHODS: Epidemiological, observational, longitudinal and multicentric study performed according to clinical practice. A total of 319 women with BPS were included, 79 with new diagnosis and 240 in follow-up. Sociodemographic and clinical data were collected together with results of cystoscopy, biopsy and physical examination. Patients completed a 3-day Bladder Diary (3dBD) and Patient Reported Outcomes (PROs). All the patients were classified according to the 6 UPOINT domains and their distribution was described according to the clinical history, diagnostic tests, urinary symptoms and PROs' scores. RESULTS: 92.8% of the patients had affectation in more than one phenotype, however, there were no remarkable differences in the clinical and sociodemographic variables according to the number of affected domains. The percentage of patients with 3C classification was higher in the urinary (8.2%), organ-specific (9.0%) and neurological (10.9%) phenotypes. Around 90% had high voiding frequency, regardless of the phenotype. The improvement reported by the PROs was superior in the neurological and tenderness phenotypes. The worst scores were associated with a greater number of affected domains. CONCLUSIONS: The present study is the first one carried out in Spain on a phenotypic classification of women with BPS, with data from routine clinical practice. The results point out that patients with several domains affected present more affectation on the BPS, worse HRQo Land higher anxiety.

OBJETIVOS: Estudiar la posibilidad de clasificar a las pacientes con SDV por los fenotipos UPOINT y su correlación con los resultados de otras herramientas diagnósticas para SDV. MATERIAL Y MÉTODOS: Estudio epidemiológico, observacional, longitudinal y multicéntrico realizado según la práctica clínica habitual. Se incluyeron 319 mujeres con SDV, 79 de nuevo diagnóstico y 240 en seguimiento. Se recogieron datos sociodemográficos y clínicos y resultados de la cistoscopia, biopsia y exploración física. Las pacientes cumplimentaron un diario miccional de 3 días y los Patient Reported Outcomes (PROs). Todas las pacientes fueron clasificadas según los 6 dominios UPOINT y se describió su distribución según la historia clínica, pruebas diagnósticas, síntomas urinarios y las puntuaciones de los PROs. RESULTADOS: El 92,8% de las pacientes tenían afectación en más de un fenotipo, sin embargo, no hubo diferencias destacables en las variables clínicas y sociodemográficas según el número de dominios afectados. El porcentaje de pacientes con clasificación 3C fue mayor en los fenotipos urológico (8,2%), órgano-específico (9,0%) y neurológico (10,9%). Alrededor del 90% presentaron frecuencia miccional elevada, independientemente del fenotipo. La mejoría reportada por los PROs fue superior en los fenotipos neurológico y tenderness. Las peores puntuaciones se asociaron a un mayor número de dominios afectados. CONCLUSIONES: El presente estudio es el primero realizado en España sobre una clasificación fenotípica de mujeres con SDV, basándose en datos de práctica clínica habitual. Los resultados obtenidos señalan una tendencia a que pacientes con afectación de varios dominios fenotípicos presentan mayor afectación por el SDV, peor CVRS y mayor ansiedad.

Clasificación fenotípica upoint de una muestra de mujeres con síndrome de dolor vesical: resultados de un estudio observacional multicéntrico nacional / Upoint phenotypic classification of a sample of women with bladder pain syndrome: results of a national multicenter observational study

Objetivos: Estudiar la posibilidad declasificar a las pacientes con SDV por los fenotiposUPOINT y su correlación con los resultados de otrasherramientas diagnósticas para SDV.Material y métodos: Estudio epidemiológico, observacional, longitudinal y multicéntrico realizado segúnla práctica clínica habitual. Se incluyeron 319 mujerescon SDV, 79 de nuevo diagnóstico y 240 en seguimiento. Se recogieron datos sociodemográficos y clínicosy resultados de la cistoscopia, biopsia y exploraciónfísica. Las pacientes cumplimentaron un diario miccional de 3 días y los Patient Reported Outcomes (PROs).Todas las pacientes fueron clasificadas según los 6 dominios UPOINT y se describió su distribución según lahistoria clínica, pruebas diagnósticas, síntomas urinariosy las puntuaciones de los PROs. Resultados: El 92,8% de las pacientes tenían afectación en más de un fenotipo, sin embargo, no hubodiferencias destacables en las variables clínicas y sociodemográficas según el número de dominios afectados.El porcentaje de pacientes con clasificación 3C fue mayor en los fenotipos urológico (8,2%), órgano-específico(9,0%) y neurológico (10,9%). Alrededor del 90% presentaron frecuencia miccional elevada, independiente-mente del fenotipo. La mejoría reportada por los PROsfue superior en los fenotipos neurológico y tenderness.Las peores puntuaciones se asociaron a un mayor número de dominios afectados.Conclusiones: El presente estudio es el primerorealizado en España sobre una clasificación fenotípicade mujeres con SDV, basándose en datos de prácticaclínica habitual. Los resultados obtenidos señalan unatendencia a que pacientes con afectación de variosdominios fenotípicos presentan mayor afectación por elSDV, peor CVRS y mayor ansiedad.(AU)

Objetives: To study the possibility ofclassifying patients with BPS by UPOINT phenotypesand their correlation with the results of different BPS diagnostic tools.Materials and methods: Epidemiological, observational, longitudinal and multicentric study performed according to clinical practice. A total of 319 women withBPS were included, 79 with new diagnosis and 240in follow-up. Sociodemographic and clinical data werecollected together with results of cystoscopy, biopsyand physical examination. Patients completed a 3-dayBladder Diary (3dBD) and Patient Reported Outcomes(PROs). All the patients were classified according to the6 UPOINT domains and their distribution was describedaccording to the clinical history, diagnostic tests, urinarysymptoms and PROs’ scores.Results: 92.8% of the patients had affectation in morethan one phenotype, however, there were no remarkable differences in the clinical and sociodemographicvariables according to the number of affected domains.The percentage of patients with 3C classification washigher in the urinary (8.2%), organspecific (9.0%) andneurological (10.9%) phenotypes. Around 90% hadhigh voiding frequency, regardless of the phenotype.The improvement reported by the PROs was superior inthe neurological and tenderness phenotypes. The worstscores were associated with a greater number of affected domains. Conclusions: The present study is the first one carried out in Spain on a phenotypic classification of women with BPS, with data from routine clinical practice. Theresults point out that patients with several domains affected present more affectation on the BPS, worse HRQoLand higher anxiety.(AU)

Bladder diary characteristics and progress in patients with painful bladder syndrome. / Características del diario miccional y su evolución en pacientes con síndrome de dolor vesical.

OBJECTIVES: The utility and importance of the 3-day Bladder Diary (3dBD) for the diagnosis and management of patients with Bladder Pain Syndrome (BPS) was analyzed. MATERIAL AND METHODS: Epidemiological, observational, longitudinal and multicentric study, carried out under usual conditions of clinical practice. 37 Functional Urology and Urodynamics units included 329 women with BPS according to the criteria of the International Society for the Study of Bladder Pain Syndrome (ESSIC). Of all patients included, 319 were evaluable (79 with new diagnosis and 240 in follow-up). Sociodemographic and clinical variables were collected together with variables related to cystoscopy, biopsy and physical examination and BPS diagnostic tests. Patients completed the "Bladder Pain/Interstitial Cystitis - Symptom Score"(BPIC-SS), "Patient Global Impression of Severity" (PGI-S) and "EuroQoL-5D-5L" (EQ-5D-5L) questionnaires besides of the 3dBD. Results of the 3dBD were described according to urinary symptoms and the symptoms reported through questionnaires, in addition their association was studied. RESULTS: In anamnesis, 74.9% of patients reported increased Urinary Frequency (UF), 59.6% urgency and72.7% nocturia compared to 88.7%, 55.9% and 73.6% as reflected in the 3dBD. The highest correlation indexes (CI) were obtained between BPIC-SS and UF/24h (0.45) and between UF/24 h and PGI-S (-0.36) and EQ-5D-5L (-0.33). Mean voiding volume was higher in patients with better BPIC-SS score (163.72 (SD 68.02ml) y 154.1 (SD 70.63 ml)), at 6 and 12 months. CONCLUSIONS: 3dBD has proven to be a useful and complementary tool to the anamnesis in the evaluation of the repercussion of pain in the micturition pattern and for the differential diagnosis of the symptoms of BPS patients. It also allows to obtain complete and objective information about the symptoms. Although it is necessary to incorporate other tools that complete the clinical characterization of these patients.

OBJETIVOS: Se analizó la utilidad e importancia del Diario Miccional de 3 días (DM3d) en el diagnóstico y manejo de las pacientes con Síndrome de Dolor Vesical (SDV).MATERIAL Y MÉTODOS: Estudio epidemiológico, observacional, longitudinal y multicéntrico, realizado en condiciones de práctica clínica habitual. 37 unidades de Urología Funcional y Urodinámica incluyeron 329 mujeres con SDV bajo criterio de la International Society for the Study of Bladder Pain Syndrome (ESSIC). 319 pacientes fueron evaluables (79 de nuevo diagnóstico y 240 en seguimiento). Se recogieron variables sociodemográficas y clínicas, variables relacionadas con la cistoscopia, biopsia y exploración física, y pruebas diagnósticas para el SDV. Las pacientes completaron los cuestionarios "Bladder Pain/Interstitial Cystitis ­Symptom Score" (BPIC-SS), "Patient Global Impression of Severity" (PGI-S), "EuroQoL-5D-5L" (EQ-5D-5L) y el DM3d. Se describieron los resultados del DM3d según los síntomas miccionales y los síntomas comunicados por las pacientes a través de cuestionarios y se estudiós u asociación. RESULTADOS: En la anamnesis, el 74,9% de pacientes reportaron frecuencia miccional (FM) aumentada, 59,6% urgencia miccional y 72,7% nocturia frente al 88,7%, 55,9%, 73,6% que reflejó el DM3d. Los mayores índices de correlación (ICC) se obtuvieron entre las puntuaciones BPIC-SS y FM/24h (0,45) y entre FM/24h y PGI-S (-0,36) y EQ-5D-5L (-0,33). El Volumen Miccional medio fue superior en las pacientes con mejor puntuación en BPIC-SS, a los 6 y 12 meses (163,72 (DE 68,02 ml) y 154,1 (DE 70,63 ml)). CONCLUSIONES: El DM3d ha demostrado ser una herramienta útil y complementaria a la anamnesis en la evaluación de la repercusión del dolor en el patrón miccional y en el diagnóstico diferencial de los síntomas de estas pacientes. Además, permite obtener información completa y objetiva de los síntomas. Si bien es necesario incorporar otras herramientas que terminen de completar la caracterización clínica de estas pacientes.

Características del diario miccional y su evolución en pacientes con síndrome de dolor vesical / Bladder diary characteristics and progress in patients with painful bladder syndrome

OBJETIVOS: Se analizó la utilidad e importancia del Diario Miccional de 3 días (DM3d) en el diagnóstico y manejo de las pacientes con Síndrome de Dolor Vesical (SDV). MATERIAL Y MÉTODOS: Estudio epidemiológico, observacional, longitudinal y multicéntrico, realizado en condiciones de práctica clínica habitual. 37 unidades de Urología Funcional y Urodinámica incluyeron 329 mujeres con SDV bajo criterio de la International Society for the Study of Bladder Pain Syndrome (ESSIC). 319 pacientes fueron evaluables (79 de nuevo diagnóstico y 240 en seguimiento). Se recogieron variables sociodemográficas y clínicas, variables relacionadas con la cistoscopia, biopsia y exploración física, y pruebas diagnósticas para el SDV. Las pacientes completaron los cuestionarios "Bladder Pain/Interstitial Cystitis - Symptom Score" (BPIC-SS), "Patient Global Impression of Severity" (PGI-S), "EuroQoL-5D-5L" (EQ-5D-5L) y el DM3d. Se describieron los resultados del DM3d según los síntomas miccionales y los síntomas comunicados por las pacientes a través de cuestionarios y se estudió su asociación. RESULTADOS: En la anamnesis, el 74,9% de pacientes reportaron frecuencia miccional (FM) aumentada, 59,6% urgencia miccional y 72,7% nocturia frente al 88,7%, 55,9%, 73,6% que reflejó el DM3d. Los mayores índices de correlación (ICC) se obtuvieron entre las puntuaciones BPIC-SS y FM/24h (0,45) y entre FM/24h y PGI-S (-0,36) y EQ-5D-5L (-0,33). El Volumen Miccional medio fue superior en las pacientes con mejor puntuación en BPIC-SS, a los 6 y 12 meses (163,72 (DE 68,02 ml) y 154,1 (DE 70,63 ml)). CONCLUSIONES: El DM3d ha demostrado ser una herramienta útil y complementaria a la anamnesis en la evaluación de la repercusión del dolor en el patrón miccional y en el diagnóstico diferencial de los síntomas de estas pacientes. Además, permite obtener información completa y objetiva de los síntomas. Si bien es necesario incorporar otras herramientas que terminen de completar la caracterización clínica de estas pacientes

OBJECTIVES: The utility and importance of the 3-day Bladder Diary (3dBD) for the diagnosis and management of patients with Bladder Pain Syndrome (BPS) was analyzed. MATERIAL AND METHODS: Epidemiological, observational, longitudinal and multicentric study, carried out under usual conditions of clinical practice. 37 Functional Urology and Urodynamics units included 329 women with BPS according to the criteria of the International Society for the Study of Bladder Pain Syndrome (ESSIC). Of all patients included, 319 were evaluable (79 with new diagnosis and 240 in follow-up). Sociodemographic and clinical variables were collected together with variables related to cystoscopy, biopsy and physical examination and BPS diagnostic tests. Patients completed the "Bladder Pain/Interstitial Cystitis - Symptom Score" (BPIC-SS), "Patient Global Impression of Severity" (PGI-S) and "EuroQoL-5D-5L" (EQ-5D-5L) questionnaires besides of the 3dBD. Results of the 3dBD were described according to urinary symptoms and the symptoms reported through questionnaires, in addition their association was studied. RESULTS: In anamnesis, 74.9% of patients reported increased Urinary Frequency (UF), 59.6% urgency and 72.7% nocturia compared to 88.7%, 55.9% and 73.6% as reflected in the 3dBD. The highest correlation indexes (CI) were obtained between BPIC-SS and UF/24h (0.45) and between UF/24 h and PGI-S (-0.36) and EQ-5D-5L (-0.33). Mean voiding volume was higher in patients with better BPIC-SS score (163.72 (SD 68.02 ml) y 154.1 (SD 70.63 ml)), at 6 and 12 months. CONCLUSIONS: 3dBD has proven to be a useful and complementary tool to the anamnesis in the evaluation of the repercussion of pain in the micturition pattern and for the differential diagnosis of the symptoms of BPS patients. It also allows to obtain complete and objective information about the symptoms. Although it is necessary to incorporate other tools that complete the clinical characterization of these patients

Análisis de costes y consecuencias relacionados con la persistencia del tratamiento con Mirabegrón y los fármacos antimuscarínicos y su impacto sobre la calidad de vida en los pacientes con vejiga hiperactiva en España: resultados de un modelo probabilístico / Analysis of costs and consequences related to the persistence of Mirabegron and antimuscarinic treatments and their impact on quality of life in patients with overactive bladder in Spain: Results of a probabilistic model

OBJETIVO: Evaluar si la menor tasa de abandonos del tratamiento de la vejiga hiperactiva (VH) con mirabegrón podría generar ahorros para el Sistema Nacional de Salud (SNS) y ganancia de años de vida ajustados por calidad (AVACs), en comparación con los fármacos antimuscarínicos (AM) (tolterodina, fesoterodina, oxibutinina, solifenacina). MÉTODOS: Modelo probabilístico (simulación de Monte Carlo de segundo orden) en una cohorte hipotética de 1.000 pacientes con VH y un horizonte temporal de 1 año. Las tasas de abandono/persistencia del tratamiento con mirabegrón y AM se obtuvieron de un estudio observacional español en 1.798 pacientes. Los costes unitarios (€ 2018) y la pérdida de utilidades ligada al abandono del tratamiento se obtuvieron de precios públicos españoles y de la literatura, respectivamente. RESULTADOS: En cada paciente tratado con mirabegrón se duplica la tasa de persistencia en comparación con los AM, ganándose anualmente 0,0151 ±0,0007 AVACs, frente a AM. Con mirabegrón se generaría un ahorro anual por paciente de 80,74 ± 4,61 € en comparación con los AM, con una probabilidad de ahorro del 100%. La sustitución hipotética de los AM por mirabegrón, generaría en el plazo de 1 año un ahorro para el SNS de 6,6 millones de euros (IC 95%3,9-10,1 millones de euros) y se ganarían 1.238 AVAC (IC95% 731; 1.885 AVAC). CONCLUSIONES: El modelo probabilístico muestra una mayor persistencia en pacientes tratados con mirabegrón en comparación con los AM, generando un impacto positivo sobre la calidad de vida de los pacientes así como ahorros para el SNS

OBJECTIVE: To evaluate whether the lower dropout rate of the treatment of overactive bladder (OAB) with mirabegron could generate cost savings to the National Health System (NHS) and lead to quality-adjusted life years (QALYs) gains, compared to the most commonly prescribed antimuscarinics (AM) in Spain (tolterodine, fesoterodine, oxybutynin, solifenacin). METHODS: A probabilistic model (second order Monte Carlo simulation) in a hypothetical cohort of 1,000 patients with OAB and a time horizon of 1 year was carried out. Discontinuation and persistence rates for both mirabegron and AM were obtained from a Spanish observational study in 1798 patients. Unit costs (€ 2018) and utility loss associated with treatment discontinuation were obtained from Spanish public prices and literature, respectively. RESULTS: Persistence rates in patients treated with mirabegron were twice as high compared to AM, leading to a QALY gain of 0.0151 ± 0.0007 per year. Treatment with mirabegron could generate savings of 80.74 ± 4.61 € per patient per year compared to AM, assuming 100% probability of saving. The hypothetical substitution of AM treatment for mirabegron could potentially generate savings of 6.6 million euros (95% CI 3.9-10.1 million euros) to the NHS and 1,238 QALYs gains (CI 95% 731; 1,885 QALYs) within a period of 1 year. CONCLUSIONS: The probabilistic model presented showed a greater persistence in patients treated with mirabegron compared to AM, leading to a positive impact in patients quality of life, as well cost savings to the NHS in Spain

[Analysis of costs and consequences related to the persistence of Mirabegron and antimuscarinic treatments and their impact on quality of life in patients with overactive bladder in Spain: Results of a probabilistic model.] / Análisis de costes y consecuencias relacionados con la persistencia del tratamiento con Mirabegrón y los fármacos antimuscarínicos y su impacto sobre la calidad de vida en los pacientes con vejiga hiperactiva en España: resultados de un modelo probabilístico.

OBJECTIVE: To evaluate whether the lower dropout rate of the treatment of overactive bladde r(OAB) with mirabegron could generate cost savings to the National Health System (NHS) and lead to quality-adjusted life years (QALYs) gains, compared to the most commonly prescribed antimuscarinics (AM) in Spain (tolterodine, fesoterodine, oxybutynin, solifenacin). METHODS: A probabilistic model (second order Monte Carlo simulation) in a hypothetical cohort of 1,000 patients with OAB and a time horizon of 1 year was carried out. Discontinuation and persistence rates for both mirabegron and AM were obtained from a Spanish observational study in 1798 patients. Unit costs (€ 2018) and utility loss associated with treatment discontinuation were obtained from Spanish public prices and literature, respectively. RESULTS: Persistence rates in patients treated with mirabegron were twice as high compared to AM, leading to a QALY gain of 0.0151 ± 0.0007 per year. Treatment with mirabegron could generate savings of 80.74 ±4.61 € per patient per year compared to AM, assuming 100% probability of saving. The hypothetical substitution of AM treatment for mirabegron could potentially generate savings of 6.6 million euros (95% CI 3.9-10.1 million euros) to the NHS and 1,238 QALYs gains (CI95%731; 1,885 QALYs) within a period of 1 year. CONCLUSIONS: The probabilistic model presented showed a greater persistence in patients treated with mirabegron compared to AM, leading to a positive impactin patients quality of life, as well cost savings to the NHS in Spain.

OBJETIVO: Evaluar si la menor tasa de abandonos del tratamiento de la vejiga hiperactiva (VH) con mirabegrón podría generar ahorros para el Sistema Nacional de Salud (SNS) y ganancia de años de vida ajustados por calidad (AVACs), en comparación con los fármacos antimuscarínicos (AM) (tolterodina, fesoterodina, oxibutinina, solifenacina).MÉTODOS: Modelo probabilístico (simulación de Monte Carlo de segundo orden) en una cohorte hipotética de 1.000 pacientes con VH y un horizonte temporal  de 1 año. Las tasas de abandono/persistencia del tratamiento con mirabegrón y AM se obtuvieron de un estudio observacional español en 1.798 pacientes. Los costes unitarios (€ 2018) y la pérdida de utilidades ligada al abandono del tratamiento se obtuvieron de precios públicos españoles y de la literatura, respectivamente. RESULTADOS: En cada paciente tratado con mirabegrón se duplica la tasa de persistencia en comparación con los AM, ganándose anualmente 0,0151 ±0,0007 AVACs, frente a AM. Con mirabegrón se generaría un ahorro anual por paciente de 80,74 ± 4,61 € en comparación con los AM, con una probabilidad de ahorro del 100%. La sustitución hipotética de los AM por mirabegrón, generaría en el plazo de 1 año un ahorro para el SNS de 6,6 millones de euros (IC 95%3,9-10,1 millones de euros) y se ganarían 1.238 AVAC (IC95% 731; 1.885 AVAC). CONCLUSIONES: El modelo probabilístico muestra una mayor persistencia en pacientes tratados con mirabegrón en comparación con los AM, generando un impacto positivo sobre la calidad de vida de los pacientes así como ahorros para el SNS.

[Management of neurourological patients during the COVID-19 pandemic.] / Manejo del paciente neurourológico durante la pandemia COVID-19.

OBJECTIVES:  To report the recommendations of an expert panel to reorganize Neurourology units and to prioritize examinations and both conservative and surgical treatments during the COVID-19 pandemic. MATERIALS AND METHODS: Non-systematic review of the literature and national experts' opinion summarizing the recommendations in the diagnosis, management, and follow-up of neurourological patients during the COVID-19 pandemic. A modified nominal group technique was used due to extraordinary meeting and mobility restrictions during COVID-19 pandemic. RESULTS: Neurourological patients have special physiological and pathological characteristics that make them more vulnerable to SARS-CoV-2 infection. For prioritization purposes, they encompass in Functional Urology patients and their management is considered non-urgentor delayable with no specific deadline of recovery from normality. However, it is important to identify individual situations jeopardising the upper urinary tract, urinary retention or predisposing to urinary infections/sepsis. A classification is provided prioritizing conservative/outpatient management and the surgical treatment of the events occurring in neurourological patients during the COVID-19 pandemic. CONCLUSIONS: In neurourological patients we can find exceptional clinical situations in which a delayed treatment could develop irreversible changes in the upper urinary tract, advocating a more urgent treatment inspecific scenarios.

OBJETIVOS: Exponer las recomendaciones de un comité de expertos para la reorganización de las unidades de neurourología y la priorización de estudios y tratamientos durante la pandemia COVID-19.MATERIAL Y MÉTODOS: Revisión no sistemática de la literatura científica y opinión de expertos nacionales  para resumir las recomendaciones en el diagnóstico, tratamiento y seguimiento de los pacientes neurourológicos durante la pandemia COVID-19. Se utiliza una técnica de grupo nominal modificada debido a las restricciones extraordinarias de reunión y movilidad durante la pandemia COVID-19. RESULTADOS: Los pacientes neurourológicos poseen características fisiopatológicas especiales que les hace más vulnerables frente a la infección por SARS-CoV-2. Han sido englobados en general en el grupo de la Urología Funcional, relegando su manejo al de las situaciones no urgentes y demorables sin plazo concreto de recuperación de la normalidad. Sin embargo, es importante identificar situaciones específicas en las que exista compromiso funcional del aparato urinario superior, retención urinaria, o desarrollo de infecciones/sepsis urinaria. Se realiza una clasificación según el nivel de prioridad tanto del manejo ambulatorio y conservador como del tratamiento quirúrgico de eventos relacionados con pacientes neurourológicos durante la pandemia COVID-19. CONCLUSIONES: En los pacientes neurourológicos encontramos situaciones clínicas excepcionales en las que un retraso de su tratamiento puede conllevar alteraciones irreversibles en el tracto urinario superior, dada su condición de vejiga de riesgo funcional, por lo que debe individualizarse un manejo más precoz en ciertos escenarios.

Manejo de la hiperplasia benigna de próstata durante la pandemia COVID-19 / Benign prostatic hyperplasia management during COVID-19 pandemia

OBJETIVOS: Exponer las recomendaciones de un comité de expertos para la reorganización de las unidades de neurourología y la priorización de estudios y tratamientos durante la pandemia COVID-19. MATERIAL Y MÉTODOS: Revisión no sistemática de la literatura científica y opinión de expertos nacionales para resumir las recomendaciones en el diagnóstico, tratamiento y seguimiento de los pacientes neurourológicos durante la pandemia COVID-19. Se utiliza una técnica de grupo nominal modificada debido a las restricciones extraordinarias de reunión y movilidad durante la pandemia COVID-19. RESULTADOS: Los pacientes neurourológicos poseen características fisiopatológicas especiales que les hace más vulnerables frente a la infección por SARS-CoV-2. Han sido englobados en general en el grupo de la Urología Funcional, relegando su manejo al de las situaciones no urgentes y demorables sin plazo concreto de recuperación de la normalidad. Sin embargo, es importante identificar situaciones específicas en las que exista compromiso funcional del aparato urinario superior, retención urinaria, o desarrollo de infecciones/sepsis urinaria. Se realiza una clasificación según el nivel de prioridad tanto del manejo ambulatorio y conservador como del tratamiento quirúrgico de eventos relacionados con pacientes neurourológicos durante la pandemia COVID-19. CONCLUSIONES: En los pacientes neurourológicos encontramos situaciones clínicas excepcionales en las que un retraso de su tratamiento puede conllevar alteraciones irreversibles en el tracto urinario superior, dada su condición de vejiga de riesgo funcional, por lo que debe individualizarse un manejo más precoz en ciertos escenarios

OBJECTIVES: To report the recommendations of an expert panel to reorganize Neurourology units and to prioritize examinations and both conservative and surgical treatments during the COVID-19 pandemic. MATERIALS AND METHODS: Non-systematic review of the literature and national experts' opinion summarizing the recommendations in the diagnosis, management, and follow-up of neurourological patients during the COVID-19 pandemic. A modified nominal group technique was used due to extraordinary meeting and mobility restrictions during COVID-19 pandemic. RESULTS: Neurourological patients have special physiological and pathological characteristics that make them more vulnerable to SARS-CoV-2 infection. For prioritization purposes, they encompass in Functional Urology patients and their management is considered non-urgent or delayable with no specific deadline of recovery from normality. However, it is important to identify individual situations jeopardising the upper urinary tract, urinary retention or predisposing to urinary infections/sepsis. A classification is provided prioritizing conservative/outpatient management and the surgical treatment of the events occurring in neurourological patients during the COVID-19 pandemic. CONCLUSIONS: In neurourological patients we can find exceptional clinical situations in which a delayed treatment could develop irreversible changes in the upper urinary tract, advocating a more urgent treatment in specific scenarios

Manejo del paciente neurourológico durante la pandemia COVID-19 / Management of neurourological patients during the COVID-19 pandemic

OBJETIVOS: Exponer las recomendaciones de un comité de expertos para la reorganización de las unidades de neurourología y la priorización de estudios y tratamientos durante la pandemia COVID-19. MATERIAL Y MÉTODOS: Revisión no sistemática de la literatura científica y opinión de expertos nacionales para resumir las recomendaciones en el diagnóstico, tratamiento y seguimiento de los pacientes neurourológicos durante la pandemia COVID-19. Se utiliza una técnica de grupo nominal modificada debido a las restricciones extraordinarias de reunión y movilidad durante la pandemia COVID-19. RESULTADOS: Los pacientes neurourológicos poseen características fisiopatológicas especiales que les hace más vulnerables frente a la infección por SARS-CoV-2. Han sido englobados en general en el grupo de la Urología Funcional, relegando su manejo al de las situaciones no urgentes y demorables sin plazo concreto de recuperación de la normalidad. Sin embargo, es importante identificar situaciones específicas en las que exista compromiso funcional del aparato urinario superior, retención urinaria, o desarrollo de infecciones/sepsis urinaria. Se realiza una clasificación según el nivel de prioridad tanto del manejo ambulatorio y conservador como del tratamiento quirúrgico de eventos relacionados con pacientes neurourológicos durante la pandemia COVID-19. CONCLUSIONES: En los pacientes neurourológicos encontramos situaciones clínicas excepcionales en las que un retraso de su tratamiento puede conllevar alteraciones irreversibles en el tracto urinario superior, dada su condición de vejiga de riesgo funcional, por lo que debe individualizarse un manejo más precoz en ciertos escenarios

OBJECTIVES: To report the recommendations of an expert panel to reorganize Neurourology units and to prioritize examinations and both conservative and surgical treatments during the COVID-19 pandemic. MATERIALS AND METHODS: Non-systematic review of the literature and national experts' opinion summarizing ther ecommendations in the diagnosis, management, and follow-up of neurourological patients during the COVID-19 pandemic. A modified nominal group technique was used due to extraordinary meeting and mobility restrictions during COVID-19 pandemic. RESULTS: Neurourological patients have special physiological and pathological characteristics that make them more vulnerable to SARS-CoV-2 infection. For prioritization purposes, they encompass in Functional Urology patients and their management is considered non-urgent or delayable with no specific deadline of recovery from normality. However, it is important to identify individual situations jeopardising the upper urinary tract, urinary retention or predisposing to urinary infections/sepsis. A classification is provided prioritizing conservative/outpatient management and the surgical treatment of the events occurring in neurourological patients during the COVID-19 pandemic. CONCLUSIONS: In neurourological patients we can find exceptional clinical situations in which a delayed treatment could develop irreversible changes in the upper urinary tract, advocating a more urgent treatment in specific scenarios

Physical exam in the evaluation of bladder pain syndrome (BPS): A key component for differential diagnosis. / La exploración física en la evaluación del síndrome de dolor vesical (SDV): un importante elemento para la orientación terapéutica.

OBJECTIVES: To describe in more detail the usual clinical practice regarding physical examination (PE) in Bladder Pain Syndrome (BPS) and to evaluate if the performance of PE relates to changes in severity of symptoms and in Health Related Quality of Life (HRQoL). MATERIAL AND METHODS: Epidemiological, observational, national and multicentric study that included 319 patients with BPS (79 of new diagnosis and 240 in follow-up). Demographic and clinical data were collected. The diagnostic study was performed according to the usual clinical practice, including as the case: PE and biopsy. The patients completed the "Bladder Pain/Interstitial Cystitis Symptom Score" (BPIC-SS) and "EuroQoL-5D-5L" (EQ-5D-5L) questionnaires. To describe the continuous variables, the mean, standard deviation (SD) and quartiles analyzed were used, and for categorical variables, number and percentage of patients by response category. The questionnaires' results were described according to the visual analog scale (VAS). Health status was evaluated in patients with myofascial pain. RESULTS: PE was performed in 296 cases. 28.4% of the patients presented pelvic myofascial pain. The variation of the BPIC-SS score in the explored patients was 7.77 points, compared to 1.73 in the unexplored ones. The variations in EQ-5D-5L were 0.13 and 0.04 points, respectively. CONCLUSIONS: Myofascial involvement was observed in 28.4% of the 296 cases of BPS who receiveda PE. It is important to implement a systematic, comprehensive method of PE at the national level in order to achieve a more precise characterization of BPS and a better evolution of the patient's symptoms and HRQoL.

OBJETIVOS: Conocer en mayor detalle la práctica clínica habitual de la exploración física (EF) del Síndrome de Dolor Vesical (SDV) y evaluar los cambios en síntomas y Calidad de Vida Relacionada con la Salud (CVRS) según los resultados de la EF.MATERIAL Y MÉTODOS: Estudio epidemiológico, observacional, nacional y multicéntrico que incluyó 319 pacientes con SDV (79 de nuevo diagnóstico y 240 en seguimiento). Se recogieron datos demográficos y clínicos. El estudio diagnóstico se realizó según práctica  clínica habitual, incluyendo según el caso: EF y biopsia. Las pacientes cumplimentaron los cuestionarios "BladderPain/Interstitial Cystitis-Symptom Score" (BPIC-SS) y "EuroQoL-5D-5L" (EQ-5D-5L). Para describir las variables continuas se utilizaron la media, desviación estándar (DE) y cuartiles analizados y para las cualitativas, el número y porcentaje de pacientes por categoría de respuesta. Los resultados de los cuestionarios se describieron según la escala visual analógica (EVA). Se evaluó el estado de salud en pacientes con dolor miofascial. RESULTADOS: Se realizó EF en 296 casos. El 28,4% de los pacientes presentaban dolor miofascial. La variación de la puntuación BPIC-SS en los pacientes explorados fue de 7,77 puntos, en comparación con los 1,73 en los no explorados. Las variaciones en EQ-5D-5L fueron 0,13 y 0,04 puntos, respectivamente. CONCLUSIONES: La implicación miofascial se observó en el 28,4% de los 296 casos de SDV sometidos a EF. Es importante implementar un método sistemático e integral de EF a nivel nacional para lograr una caracterización más precisa del SDV y una mejor evolución de los síntomas y CVRS del paciente.

La exploración física en la evaluación del síndrome de dolor vesical (SDV): un importante elemento para la orientación terapéutica / Physical exam in the evaluation of bladder pain syndrome (BPS): A key component for differential diagnosis

OBJETIVOS: Conocer en mayor detalle la práctica clínica habitual de la exploración física (EF) del Síndrome de Dolor Vesical (SDV) y evaluar los cambios en síntomas y Calidad de Vida Relacionada con la Salud (CVRS) según los resultados de la EF. MATERIAL Y MÉTODOS: Estudio epidemiológico, observacional, nacional y multicéntrico que incluyó 319 pacientes con SDV (79 de nuevo diagnóstico y 240 en seguimiento). Se recogieron datos demográficos y clínicos. El estudio diagnóstico se realizó según práctica clínica habitual, incluyendo según el caso: EF y biopsia. Las pacientes cumplimentaron los cuestionarios "BladderPain/Interstitial Cystitis-Symptom Score" (BPIC-SS) y "EuroQoL-5D-5L" (EQ-5D-5L). Para describir las variables continuas se utilizaron la media, desviación estándar (DE) y cuartiles analizados y para las cualitativas, el número y porcentaje de pacientes por categoría de respuesta. Los resultados de los cuestionarios se describieron según la escala visual analógica (EVA). Se evaluó el estado de salud en pacientes con dolor miofascial. RESULTADOS: Se realizó EF en 296 casos. El 28,4% de los pacientes presentaban dolor miofascial. La variación de la puntuación BPIC-SS en los pacientes explorados fue de 7,77 puntos, en comparación con los 1,73 en los no explorados. Las variaciones en EQ-5D-5L fueron 0,13 y 0,04 puntos, respectivamente. CONCLUSIONES: La implicación miofascial se observó en el 28,4% de los 296 casos de SDV sometidos a EF. Es importante implementar un método sistemático e integral de EF a nivel nacional para lograr una caracterización más precisa del SDV y una mejor evolución de los síntomas y CVRS del paciente

OBJECTIVES: To describe in more detail the usual clinical practice regarding physical examination (PE) in Bladder Pain Syndrome (BPS) and to evaluate if the performance of PE relates to changes in severity of symptoms and in Health Related Quality of Life (HRQoL). MATERIAL AND METHODS: Epidemiological, observational, national and multicentric study that included 319 patients with BPS (79 of new diagnosis and 240 in follow-up). Demographic and clinical data were collected. The diagnostic study was performed according to the usual clinical practice, including as the case: PE and biopsy. The patients completed the "Bladder Pain/ Interstitial Cystitis Symptom Score" (BPIC-SS) and "EuroQoL- 5D-5L" (EQ-5D-5L) questionnaires. To describe the continuous variables, the mean, standard deviation (SD) and quartiles analyzed were used, and for categorical variables, number and percentage of patients by response category. The questionnaires' results were described according to the visual analog scale (VAS). Health status was evaluated in patients with myofascial pain. RESULTS: PE was performed in 296 cases. 28.4% of the patients presented pelvic myofascial pain. The variation of the BPIC-SS score in the explored patients was 7.77 points, compared to 1.73 in the unexplored ones. The variations in EQ-5D-5L were 0.13 and 0.04 points, respectively. CONCLUSIONS: Myofascial involvement was observed in 28.4% of the 296 cases of BPS who received a PE. It is important to implement a systematic, comprehensive method of PE at the national level in order to achieve a more precise characterization of BPS and a better evolution of the patient's symptoms and HRQoL

Position of Ibero-American Society of Neurourology and UroGynecology (SINUG) on the use of vaginal meshes in pelvic organ prolapse.

AIMS: Pelvic organ prolapse (POP) is a very prevalent condition with a great impact on women's quality of life. At present, there is great controversy regarding the use of mesh in POP surgery. To understand the current moment, it is advisable to make a brief summary of the historical evolution of mesh use for pelvic floor pathology. The aim of this paper is to establish the position of the Ibero-American Society of Neurourology and UroGynecology (SINUG for its acronym in Spanish) regarding vaginal mesh reconstructive surgery. METHODS: A working committee from the SINUG's scientific board performed a literature search about the use of vaginal meshes for pelvic organ prolapse reconstructive surgery and about the position of different societies. We analyzed the evolution into three periods: before the Food and Drug Administration (FDA) statement, FDA statement, and after the statement. SINUG drew up a position statement regarding vaginal mesh reconstructive surgery, based on the available scientific evidence and the evolution of its use in different contexts. RESULTS: Before mesh appearance in the 1990s, native tissue repair was the surgical treatment of choice for POP. Vaginal mesh reconstructive surgery has been frequently accompanied by procedure underestimation by inexperienced surgeons, besides inadequate diagnoses and indications. This situation led to the presentation of serious complications including mesh extrusion, exposure, and contraction. CONCLUSIONS: Once reviewed the available evidence and the position of different societies, SINUG presents its vision in this communication, which is a summary of the document prepared by the society's scientific board.

Position of the Ibero-American Society of Neurourology and Urogynecology in relation to the use of synthetic suburethral meshes for the surgical treatment of female stress incontinence.

AIMS: The aim of this paper is to stablish de position of the Ibero-American Society of Neurourology and Urogynecology (SINUG) in relation to the use of suburethral meshes for the surgical treatment of female stress incontinence. METHODS: Tension-free mid-urethral slings (MUS) have become the most popular procedure for the treatment of stress urinary incontinence (SUI). In July 2018, the British government announced a pause in the use of meshes for both pelvic organ prolapse (POP) and urinary incontinence (UI) treatment without differentiating whether the meshes were used for treating UI or POP. The decision was taken to stop their use until the publication of the updated UI and POP guidelines of the British National Health Service, which is available from April 2019. SINUG has reviewed the evidence and official position of different societies in relation to the safety and efficacy of MUS in the surgical treatment of incontinence differentiating them from meshes used to repair POP. RESULTS: Data from synthetic mesh manufacturers indicate that in 2010, 300 000 women underwent surgical procedures to repair POP and approximately 260 000 were operated on for SUI. According to these estimates, approximately more than 80% of the surgical techniques for UI treatment were performed transvaginally with meshes. CONCLUSIONS: Once reviewed evidence and position of different societies, the SINUG presents its vision in this communication, which is a summary of the document analysing the state of topic prepared by the society.

[Cost effectiveness of Mirabegron and antimuscarinic drugs in patients with hiperactive bladder.] / Coste-efectividad de mirabegrón y los antimuscarínicos en pacientes con vejiga hiperactiva.

OBJECTIVE: To evaluate the costeffectivenessof mirabegron in comparison to theantimuscarinic drugs tolterodine, solifenacin andfesoterodine, in the treatment of urgency, increasedmicturition frequency and urinary incontinence in patientswith overactive bladder (OAB). MATERIAL AND METHODS: A Markov model in Excel,with a time horizon of 5 years was developed fromthe National Health System and societal perspective.Clinical effectiveness was estimated from a clinical trial(SCORPIO) and a network meta-analysis. Unit costswere obtained from Spanish sources. The effectivenessof the treatments was measured as quality adjusted lifeyears(QALY). Deterministic and probabilistic sensitivityanalyses were performed. RESULTS: For the 5-year time horizon, the incrementalcost per patient with mirabegron 50 mg versustolterodine was € 195.52 and € 157.42, from theNational Health System (NHS) and societal perspectivesrespectively, with a gain of 0.0127 QALY withmirabegron. Consequently, the cost of gaining a QALYwith mirabegron versus tolterodine was 15,432 € and12,425 € respectively. The probability that mirabegronwould be cost-effective at a willingness to pay thresholdof € 30,000 was: 70% (NHS) and 71% (society)versus tolterodine; 94% (NHS and society) versussolifenacin 5 mg; 84% (NHS) and 84.5% (society)versus solifenacin 10 mg; 96% (NHS and society)versus fesoterodine 4 mg; 98% (NHS) and 99% (society)versus fesoterodine 8 mg. The highest probability thatmirabegron would be cost-effective at a willingness topay threshold of € 20.000 and € 25.000 per QALYgained, is obtained versus fesoterodine 4 mg and 8 mgfrom both NHS and society perspectives. CONCLUSIONS: The treatment of patients with OABwith mirabegron 50 mg is likely to be cost-effectivecompared to treatment with antimuscarinics.

OBJETIVO: Evaluar el coste-efectividad de mirabegrón frente a los fármacos antimuscarínicos tolterodina, solifenacina y fesoterodina, en el tratamiento sintomático de la urgencia, el aumento de la frecuencia miccional y la incontinencia de urgencia en los pacientescon vejiga hiperactiva (VH).MÉTODOS: Modelo de Markov en Excel, con un horizonte temporal de 5 años, desde la perspectiva del Sistema Nacional de Salud y de la sociedad. La efectividad clínica se obtuvo de un ensayo clínico frente a tolterodina y de un metaanálisis. Los costes unitarios se obtuvieron de fuentes españolas. La efectividad de los tratamientos se midió como años de vida ajustados por calidad de vida (AVAC). Se realizaron análisis de sensibilidad determinísticos y probabilísticos. RESULTADOS: Para el horizonte temporal de 5 años, el coste incremental por paciente con mirabegrón 50 mg frente a tolterodina es de 195,52 € y 157,42 €, desde las perspectivas del Sistema Nacional de Salud (SNS) y social, respectivamente, con una ganancia de 0,0127 AVAC con mirabegrón. El coste de ganar un AVAC con mirabegrón frente a tolterodina sería de 15.432 € y de 12.425 €, respectivamente. La probabilidad de que mirabegrón sea coste-efectivo frente a tolterodina, sería del 70% y del 71%, respectivamente. Para el SNS, la probabilidad de coste-efectividad de mirabegrón frente a solifenacina 5 y 10 mg sería del 84% y del 84,5%, respectivamente y en comparación con fesoterodina 4 y 8 mg sería del 96% y 98%, respectivamente. CONCLUSIONES: El tratamiento de los pacientes con VH con mirabegrón 50 mg es probablemente coste- efectivo en comparación con el tratamiento con antimuscarínicos.

Coste-efectividad de mirabegrón y los antimuscarínicos en pacientes con vejiga hiperactiva / Cost effectiveness of Mirabegron and antimuscarinic drugs in patients with hiperactive bladder

OBJETIVO: Evaluar el coste-efectividad de mirabegrón frente a los fármacos antimuscarínicos tolterodina, solifenacina y fesoterodina, en el tratamiento sintomático de la urgencia, el aumento de la frecuencia miccional y la incontinencia de urgencia en los pacientes con vejiga hiperactiva (VH). MÉTODOS: Modelo de Markov en Excel, con un horizonte temporal de 5 años, desde la perspectiva del Sistema Nacional de Salud y de la sociedad. La efectividad clínica se obtuvo de un ensayo clínico frente a tolterodina y de un metaanálisis. Los costes unitarios se obtuvieron de fuentes españolas. La efectividad de los tratamientos se midió como años de vida ajustados por calidad de vida (AVAC). Se realizaron análisis de sensibilidad determinísticos y probabilísticos. RESULTADOS: Para el horizonte temporal de 5 años, el coste incremental por paciente con mirabegrón 50 mg frente a tolterodina es de 195,52 Euros y 157,42 Euros, desde las perspectivas del Sistema Nacional de Salud (SNS) y social, respectivamente, con una ganancia de 0,0127 AVAC con mirabegrón. El coste de ganar un AVAC con mirabegrón frente a tolterodina sería de 15.432 Euros y de 12.425 Euros, respectivamente. La probabilidad de que mirabegrón sea coste-efectivo frente a tolterodina, sería del 70% y del 71%, respectivamente. Para el SNS, la probabilidad de coste-efectividad de mirabegrón frente a solifenacina 5 y 10 mg sería del 84% y del 84,5%, respectivamente y en comparación con fesoterodina 4 y 8 mg sería del 96% y 98%, respectivamente. conclusiones: El tratamiento de los pacientes con VH con mirabegrón 50 mg es probablemente coste- efectivo en comparación con el tratamiento con antimuscarínicos

OBJECTIVE: To evaluate the costeffectiveness of mirabegron in comparison to the antimuscarinic drugs tolterodine, solifenacin and fesoterodine, in the treatment of urgency, increased micturition frequency and urinary incontinence in patients with overactive bladder (OAB). MATERIAL AND METHODS: A Markov model in Excel, with a time horizon of 5 years was developed from the National Health System and societal perspective. Clinical effectiveness was estimated from a clinical trial (SCORPIO) and a network meta-analysis. Unit costs were obtained from Spanish sources. The effectiveness of the treatments was measured as quality adjusted lifeyears (QALY). Deterministic and probabilistic sensitivity analyses were performed. RESULTS: For the 5-year time horizon, the incremental cost per patient with mirabegron 50 mg versus tolterodine was Euros 195.52 and Euros 157.42, from the National Health System (NHS) and societal perspectives respectively, with a gain of 0.0127 QALY with mirabegron. Consequently, the cost of gaining a QALY with mirabegron versus tolterodine was 15,432 Euros and 12,425 Euros respectively. The probability that mirabegron would be cost-effective at a willingness to pay threshold of Euros 30,000 was: 70% (NHS) and 71% (society) versus tolterodine; 94% (NHS and society) versus solifenacin 5 mg; 84% (NHS) and 84.5% (society) versus solifenacin 10 mg; 96% (NHS and society) versus fesoterodine 4 mg; 98% (NHS) and 99% (society) versus fesoterodine 8 mg. The highest probability that mirabegron would be cost-effective at a willingness to pay threshold of Euros 20.000 and Euros 25.000 per QALY gained, is obtained versus fesoterodine 4 mg and 8 mg from both NHS and society perspectives. CONCLUSIONS: The treatment of patients with OAB with mirabegron 50 mg is likely to be cost-effective compared to treatment with antimuscarinics

[Expert opinion about the use of transdermic oxybutynin in Spain for the treatment of adult overactive bladder.] / Opinión de expertos sobre el uso de la oxibutinina transdérmica en España para el tratamiento de la vejiga hiperactiva en adultos.

OBJECTIVES: To define the different characteristics of transdermal oxybutynin (TO) for the treatment of overactive bladder in adults, to know the barriers for the use of this drug and to establish proposals to minimize these barriers. METHODS: Local sessions were held with 111 urologists from all over the country divided into 12 sessions. They were moderated by a brainstorming technique led by an external consultant. RESULTS: 75% of experts believe that tolerability and clinical efficacy (50%) are the most important attributes to choose this formulation, being the lack of scientific publications the least valued (12%). These opinions were based on their own clinical experience with TO or on scientific publications, without establishing comparison with other treatment options. The main barriers would be administrative obstacles (84%), difficulty in its use (54%) and the lack/rejection of the transdermal administration by the patient (33%). Actions were proposed to correct the 8 most significant barriers, such as better training for specialists (both Urology and other specialties) and for patients, creating informative materials to reinforce health education in managing patches, generating greater volume of scientific evidence to support their use in overactive bladder and clearly identifying the profile of patients who will benefit most from this therapeutic strategy. CONCLUSIONS: Although oxybutynin has been standard treatment of overactive bladder in recent years the conclusion of this working group is that its new transdermal formulation offers a better-tolerated alternative for patients, and, therefore the necessary tools to generate more evidence should be implemented to increase the proper use among specialists and patients.

Opinión de expertos sobre el uso de la oxibutinina transdérmica en España para el tratamiento de la vejiga hiperactiva en adultos / Expert opinión about the use of transdermic oxybutynin in Spain for the treatment of adult overactive bladder

OBJETIVO: Definir las características diferenciales de la oxibutinina transdérmica (OT) en el tratamiento de la vejiga hiperactiva en pacientes adultos, conocer las barreras de uso y establecer propuestas para minimizar estas barreras. MÉTODOS: Se realizaron 12 sesiones de ámbito local a las que acudieron 111 urólogos en total de todo el territorio nacional, que fueron moderadas mediante una técnica de brainstorming dirigida por un consultor externo. RESULTADOS: El 75% de los expertos opina que la tolerabilidad y la eficacia clínica (50%) son los 'atributos' más importantes para escoger esta formulación, siendo el menos valorado la escasez de publicaciones científicas (12%), basándose en su propia experiencia clínica con OT o la referida en publicaciones científicas, sin establecer comparación con otras alternativas de tratamiento. Las principales 'barreras' para su uso serían las trabas administrativas (84%), la dificultad en su manejo (54%) y el desconocimiento-rechazo de la vía transdérmica por parte del paciente (33%). Se acordaron acciones para subsanar las 8 barreras más significativas, como mayor formación para especialistas (tanto Urología como otras especialidades) y para pacientes, creación de materiales informativos para reforzar la educación en el manejo de parches, generar mayor volumen de evidencia científica que avale su uso en la vejiga hiperactiva e identificar claramente los perfiles de pacientes más beneficiarios de esta estrategia terapéutica. CONCLUSIONES: Este grupo de expertos identificó la tolerabilidad y eficacia como los dos atributos clave que debe tener un fármaco para el tratamiento de la vejiga hiperactiva, de los cuales la OT destaca en el primero de ellos. Además, deben emprenderse acciones formativas, educativas y de investigación a todos los actores implicados con el fin de superar las barreras que dificultan el correcto manejo de este fármaco

OBJECTIVES: To define the different characteristics of transdermal oxybutynin (TO) for the treatment of overactive bladder in adults, to know the barriers for the use of this drug and to establish proposals to minimize these barriers. METHODS: Local sessions were held with 111 urologists from all over the country divided into 12 sessions. They were moderated by a brainstorming technique led by an external consultant. RESULTS: 75% of experts believe that tolerability and clinical efficacy (50%) are the most important attributes to choose this formulation, being the lack of scientific publications the least valued (12%). These opinions were based on their own clinical experience with TO or on scientific publications, without establishing comparison with other treatment options. The main barriers would be administrative obstacles (84%), difficulty in its use (54%) and the lack/rejection of the transdermal administration by the patient (33%). Actions were proposed to correct the 8 most significant barriers, such as better training for specialists (both Urology and other specialties) and for patients, creating informative materials to reinforce health education in managing patches, generating greater volume of scientific evidence to support their use in overactive bladder and clearly identifying the profile of patients who will benefit most from this therapeutic strategy. CONCLUSIONS: Although oxybutynin has been standard treatment of overactive bladder in recent years the conclusion of this working group is that its new transdermal formulation offers a better-tolerated alternative for patients, and, therefore the necessary tools to generate more evidence should be implemented to increase the proper use among specialists and patients

The 3-day bladder diary is a feasible, reliable and valid tool to evaluate the lower urinary tract symptoms in women.

AIMS: To evaluate the feasibility (% of completion), reliability (test-retest and inter-observer) and validity (convergent vs. questionnaires and vs. urodynamic study-UDS) of the 3-day bladder diary (3dBD) in women with lower urinary tract symptoms (LUTS). METHODS: Epidemiological, descriptive, cross-sectional and prospective study. Fourteen Functional Urology and Urodynamic Units participated. One hundred thirty-six women with mean age (SD) 55.2 (13.8) years with LUTS, without bladder catheterization and who were able to fill in the 3dBD were included. An UDS was performed. They filled in the 3dBD in two times separated by 15 days (test and retest), the International Consultation on Incontinence-Short Form (ICIQ-UI SF) and the Bladder Control Self-Assessment Questionnaire (BSAQ). RESULTS: One hundred ten women completed 3dBD for test and retest. Feasibility: each 3dBD has 42 variables, 77.2% women completed 80%. Test-retest reliability: there were not differences in the proportion of patients classified as positive for each symptom (urgency: P = 0.3173; incontinence: P = 1; nocturia: P = 0.0522; frequency: P = 0.4386). The Intraclass Correlation Coefficient (ICC) ranged from 0.67 to 0.92, except for night time VVmax which was lower (0.54). Inter-observer reliability: ICC ranged from 0.64 to 0.99, except for day time VVmax (0.29) and the number of urgency episodes (0.45). VALIDITY: Spearman correlation coefficients for ICIQ-UI SF and BSAQ ranged from 0.4 to 0.6 (P < 0.0001) and for UDS were lower (P < 0.05). CONCLUSIONS: The 3dBD showed good feasibility, reliability and validity to be used in the assessment of LUTS in women.