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.

Unlocking the Potential of Adequate Bacillus Calmette-Guérin Immunotherapy in Very-high-risk Non-muscle-invasive Bladder Carcinoma: A Multicenter Analysis of Oncological Outcomes and Risk Dynamics.

BACKGROUND: The European Association of Urology (EAU) recommends discussing upfront radical cystectomy for all patients with very high risk (VHR) non-muscle-invasive bladder carcinoma (NMIBC), but the role of bacillus Calmette-Guérin (BCG) treatment remains controversial. OBJECTIVE: To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG. DESIGN, SETTING, AND PARTICIPANTS: A multi-institutional retrospective study involving patients with VHR NMIBC who received adequate BCG therapy from 2007 to 2020 was conducted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A survival analysis estimated recurrence-free survival (RFS), progression-free survival (PFS), and the cumulative incidence of cancer-specific mortality (CSM) after accounting for other causes of mortality as competing risk events and of the overall mortality (OM). Conditional survival probabilities for 0-4 yr without events were computed. Cox regression assessed the predictors of oncological outcomes. RESULTS AND LIMITATION: A total of 640 patients, with a median 47 (32-67) mo follow-up for event-free individuals, were analyzed. High-grade RFS and PFS at 5 yr were 53% (49-57%) and 78% (74-82%), respectively. The cumulative incidence of CSM and OM at 5 yr was 13% (10-16%) and 16% (13-19%), respectively. Conditional RFS, PFS, overall survival, and cancer-specific survival at 4 yr were 91%, 96%, 87%, and 94%, respectively. Cox regression identified tumor grade (hazard ratio [HR]: 1.54; 1.1-2) and size (HR: 1.3; 1.1-1.7) as RFS predictors. Tumor multiplicity predicted RFS (HR: 1.6; 1.3-2), PFS (HR: 2; 1.2-3.3), and CSM (HR: 2; 1.2-3.2), while age predicted OM (HR: 1.48; 1.1-2). CONCLUSIONS: Patients with VHR NMIBC who receive adequate BCG therapy have a more favorable prognosis than predicted by EAU risk groups, especially among those with a sustained response, in whom continuing maintenance therapy emerges as a viable alternative to radical cystectomy. PATIENT SUMMARY: Our research shows that a sustained response to bacillus Calmette-Guérin in patients can lead to favorable outcomes, serving as a viable alternative to cystectomy for select cases.

Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial.

BACKGROUND: Incisional hernia is a common complication after kidney transplantation with an incidence of 1.6-18%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after kidney transplantation with minimal risk for complication. METHODS/DESIGN: This is a blinded, randomized controlled trial comparing time to incisional hernia over a period of 24 months between patients undergoing kidney transplantation and standardized abdominal closure with or without prophylactic placement of ProGrip™ (Medtronic, Fridley, MN, USA) mesh in an onlay position. As we believe that the mesh intervention is superior to the standard procedure in reducing the incidence of hernia, this is a superiority trial. DISCUSSION: The high risk for developing incisional hernia following kidney transplantation might be reduced by prophylactic mesh placement. ProGrip™ mesh features polylactic acid (PLA) microgrips that provide immediate, strong and uniform fixation. The use of this mesh combines the effectiveness demonstrated by the macropore propylene meshes in the treatment of incisional hernias, a high simplicity of use provided by its capacity for self-fixation that does not increase significantly surgery time, and safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02-18-2021).

Schwannoma of the seminal vesicle: Case report and review of the literature.

Seminal vesicles can be affected by tumours originating in other locations. However, primary tumours of the seminal vesicle are extremely rare, with less than 100 cases reported in literature. Seminal vesicle adenocarcinoma is the most common type, but there are also other malign lesions. Diagnosis is challenging due to the lack of early symptoms and well-defined criteria. These tumours are usually asymptomatic and discovered incidentally during imaging tests or pelvic surgery. Definitive diagnosis requires anatomopathological analysis. Case report of 58-years-old man with schwannoma of the seminal vesicle. We describe the main characteristics of these tumours as well as their therapeutic approach.

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.

Oncological and Renal Function Outcomes in Patients Who Underwent Simultaneous Radical Cystectomy and Nephroureterectomy for Synchronous or Metachronous Panurothelial Carcinoma.

OBJECTIVE: To assess clinical outcomes of patients who underwent simultaneous radical cystectomy (RC) and radical nephroureterectomy (RNU) for panurothelial carcinoma (PanUC). MATERIALS AND METHODS: A retrospective analysis of 67 patients who underwent simultaneous RC and unilateral RNU for PanUC, from 1996 to 2017. Kaplan-Meier estimates for remnant urothelium recurrence-free survival, metastasis-free survival, overall survival (OS), and cancer-specific survival (CSS) were performed. Cox multivariate models were constructed. RESULTS: The median follow-up was 38 months, 29.8% of patients had a recurrence, 34.3% had metastasis, 67.2% of patients died from any cause, and 37.3% died from urothelial carcinoma. Overall survival and CSS rates at 5 years were 44% and 61%, respectively. In multivariate analysis, progression to muscle-invasive bladder cancer before surgery, presence of muscle-invasive stages at RC and/or RNU, and prostatic urethra involvement were predictors for worse metastasis-free survival and CSS. Forty-one patients (61.2%) had an estimated glomerular filtration rate (eGFR) <60 mL/min before surgery and the number rose to 56 (83.5%) after surgery; 29.8% patients needed renal function replacement therapy after surgery (16 haemodialysis and 4 renal transplant). CONCLUSION: Patients with PanUC who undergo simultaneous surgery have adverse oncological (only 4 out of every 10 remain alive at 5 years) and functional outcomes (1 out of 3 will need renal function replacement therapy after surgery). Up to a third of the patients had a recurrence (urethra or contralateral kidney) within 18 months, justifying close surveillance or considering prophylactic urethrectomy. These data should help in counsel on morbidity and life expectancy.

Long-term Recurrence and Progression Patterns in a Contemporary Series of Patients with Carcinoma In Situ of the Bladder With or Without Associated Ta/T1 Disease Treated with Bacillus Calmette-Guérin: Implications for Risk-adapted Follow-up.

BACKGROUND: Limited data are available on patients with carcinoma in situ (CIS) of the bladder managed according to current clinical practice guidelines. OBJECTIVE: To assess the patterns of recurrence, progression to muscle-invasive bladder cancer (MIBC), and upper tract urothelial carcinoma (UTUC) in patients with CIS, and to compare the effectiveness of adequate versus inadequate bacillus Calmette-Guérin (BCG) immunotherapy. DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of 386 patients with CIS of the bladder with or without associated pTa/pT1 disease treated with BCG between 2008 and 2015. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Kaplan-Meier estimations and an inverse probability of treatment weighting (IPTW)-Cox regression were performed to compare recurrence-free survival (RFS) and progression-free survival (PFS) and UTUC incidence over time for patients who received adequate versus inadequate BCG treatment. RESULTS AND LIMITATIONS: The median follow-up was 70.5 mo. At 5 and 10 yr, RFS was 82% and 52%, PFS was 93.6% and 75.8%, and UTUC incidence was 1.7% and 2.9%, respectively. Most recurrence (73.6%) and progression (69.1%) events occurred in the first 3 yr of follow-up, while 38.7% of UTUC incident events were recorded after 5 yr of follow-up. IPTW-Cox regression revealed that patients who received BCG treatment had a lower risk of recurrence (hazard ratio [HR] 0.21, 95% confidence interval [CI] 0.13-0.34), progression (HR 0.46, 95% CI 0.25-0.87), and UTUC incidence (HR 0.24, 95% CI 0.09-0.64). Limitations include the retrospective design and potential selection bias. CONCLUSIONS: Patients with CIS of the bladder show a high risk of recurrence, progression, and UTUC incidence. Most of these outcomes occur during the first 3 yr of follow-up, but a significant proportion of the events occur at long-term follow-up. Although receipt of adequate BCG treatment improves outcomes, intensive and long-term surveillance may be warranted. PATIENT SUMMARY: We investigated the long-term cancer control outcomes for patients with carcinoma in situ (CIS; cancerous cells that have not spread from where they first formed) of the bladder. Patients with CIS have a high risk of cancer recurrence and progression. Treatment with bacillus Calmette-Guérin (BCG) improves outcomes.

Kidney Autotransplantation and Orthotopic Kidney Transplantation: Two Different Approaches for Complex Cases.

Introduction: Transplantation surgery teams often have to face complex cases. In certain circumstances, such as occlusion of the iliac vessels or prior pelvic surgery, heterotopic kidney transplantation may not be feasible and orthotopic kidney transplantation (OKT) could be a good alternative. Kidney autotransplantation (KAT) has been described as a potential treatment for complex renovascular, ureteral, or neoplastic conditions. There are scarce data regarding the complications and outcomes of these procedures; therefore, we present our experience. Materials and Methods: We retrospectively analysed the medical records of both 21 patients who had received OKT and 19 patients who underwent KAT between 1993 and 2020. We collected demographic features and data regarding surgical technique, complications, and graft outcomes. Kidney graft survival was calculated using Kaplan-Meier survival analysis. Results: Regarding OKT, in 15 (71.43%) cases, it was the first kidney transplantation. The most common indication was the unsuitable iliac region due to vascular abnormalities (57.14%). The early postoperative complication rate was high (66.67%), with 23.81% of Clavien grade 3b complications. During the follow-up period (mean 5.76 -SD 6.15- years), we detected 9 (42.85%) graft losses. At 1 year, the survival rate was 84.9%. Concerning KAT, the most frequent indication was ureteral pathology (52.63%), followed by vascular lesions (42.11%). The overall early complication rate was 42.11%. During the follow-up period (mean of 4.47 years), 4 (15.79%) graft losses were reported. Conclusions: Although OKT and KAT have high complication rates, these techniques can be considered as two valuable approaches for complex cases, in the absence of other therapeutic options.

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.

Validation of a 3 day electronic bladder diary as an app for smart-phone.

AIM: To validate an electronic 3-day bladder diary (BD) as an easy-to-use app for smart-phone (eDM3d). METHODS: Descriptive and cross-sectional prospective study. One hundred and thirty-six patients with overactive bladder syndrome (OABs) or nocturia who had a smart-phone and attended the urology clinics of a tertiary hospital from June to November 2017 were included. Patients filled the eDM3d (test) and the Spanish validated paper BD (DM3d) and questionnaires ICIQ-UISF and BASQ during the first week. Two weeks later, they repeated the eDM3d (retest). We assessed feasibility of the eDM3d (percentage of variables completed), test-retest reliability (qualitative variables: McNemar test; quantitative variables: ICC), paper-app correlation (qualitative variables: Kappa index; quantitative variables: ICC) and convergent validity (correlation between eDM3d and questionnaires, Spearman's rank test). Patients answered a question about satisfaction: "If you had to repeat a BD again, would you choose paper or the app version?" RESULTS: One hundred and twenty-three (90.4%) participants completed all the variables of the first eDM3d. There were no significant differences in the proportion of patients classified as positive for each symptom between test and retest. ICC ranged from 0.73 to 0.94 for all variables (P < 0.001) in the test-retest assessment. Paper-app correlation was good to excellent for all variables (ICC 0.76-0.95, P < 0.001; Kappa index 0.56-0.84, P < 0.001). Correlation between the eDM3d and the questionnaires ranged from 0.23 to 0.6 (P < 0.01). 120 (88.2%) patients would choose the eDM3d if they had to repeat a BD. CONCLUSION: The eDM3d presents suitable feasibility, reliability, and validity to assess patients with OABs or nocturia who have a smart-phone.

[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

Phosphodiesterase type 4 inhibition enhances nitric oxide- and hydrogen sulfide-mediated bladder neck inhibitory neurotransmission.

Nitric oxide (NO) and hydrogen sulfide (H2S) play a pivotal role in nerve-mediated relaxation of the bladder outflow region. In the bladder neck, a marked phosphodiesterase type 4 (PDE4) expression has also been described and PDE4 inhibitors, as rolipram, produce smooth muscle relaxation. This study investigates the role of PDE4 isoenzyme in bladder neck gaseous inhibitory neurotransmission. We used Western blot and double immunohistochemical staining for the detection of NPP4 (PDE4) and PDE4A and organ baths for isometric force recording to roflumilast and tadalafil, PDE4 and PDE5, respectively, inhibitors in pig and human samples. Endogenous H2S production measurement and electrical field stimulation (EFS) were also performed. A rich PDE4 and PDE4A expression was observed mainly limited to nerve fibers of the smooth muscle layer of both species. Moreover, roflumilast produced a much more potent smooth muscle relaxation than that induced by tadalafil. In porcine samples, H2S generation was diminished by H2S and NO synthase inhibition and augmented by roflumilast. Relaxations elicited by EFS were potentiated by roflumilast. These results suggest that PDE4, mainly PDE4A, is mostly located within nerve fibers of the pig and human bladder neck, where roflumilast produces a powerful smooth muscle relaxation. In pig, the fact that roflumilast increases endogenous H2S production and EFS-induced relaxations suggests a modulation of PDE4 on NO- and H2S-mediated inhibitory neurotransmission.

Development and feasibility assessment of a 3 day electronic bladder diary as an app for smart-phone.

AIMS: To develop a 3 day bladder diary (BD) as an easy-to-use application for smart-phone (eDM3d). To test its feasibility and acceptance in a reduced number of patients. METHODS: An external agency developed the eDM3d following the structure of the Spanish validated 3 day BD (DM3d©), which includes a frequency-volume chart, the assessment of the grade of urgency, the incontinence events and fluid intake. The eDM3d consisted in a main interface of four buttons ("wake up," "go to bed," "urinate," "drink") which had to be clicked to create an event. Results were automatically transferred to an internet server to obtain an electronic report. We recruited 25 patients with overactive bladder syndrome or nocturia and previous experience on paper BD. They were asked to complete the eDM3d. Finally, a direct question about satisfaction was answered: "If you had to complete a BD again, would you choose the paper or the app version?" RESULTS: Three patients (12%) did not complete the eDM3d, 1 patient (4%) completed 2 days of the eDM3d and did not register volumes of micturition nor fluid intake, 1 patient (4%) completed all 2 days variables and 20 patients (80%) completed all 3 day variables. Regarding satisfaction, 19 patients (86.4%) would choose the app version, 2 patients (9.1%) would choose a paper version and 1 patient (4.5%) would choose either indistinctly. CONCLUSIONS: The eDM3d is a useful tool easily filled in by patients with a high satisfaction rate. Adequate validation of the eDM3d is required.

[Intravesical botulinum toxin under local anestesia as ambulatory procedure.] / Toxina botulínica intravescal con anestesia local como procedimiento ambulante.

Bladder hyperactivity is described as the presence of "voiding urgency, generally associated with increased daytime frequency and nocturia, with or without urinary incontinence, in the absence of urinary tract infection or other obvious pathology". Onabotulinum toxin A (BTA) is a recommendable therapeutic option in case of failure, contraindication or refusal of the conservative therapy or other non-pharmacological therapies. The injection of BTA in the detrusor has been performed under local, regional or general anesthesia either in the conventional or major ambulatory surgery operative room or in the cystoscopy room. The objective of this paper is to describe the procedure to perform BTA therapy as an ambulatory operation under intravesical local anesthesia in the cystoscopy room, describing its advantages and limitations.

Toxina botulínica intravescal con anestesia local como procedimiento ambulante / Intravesical botulinum toxin under local anestesia as ambulatory procedure

El síndrome de hiperactividad vesical se define como la presencia de "urgencia miccional, habitualmente asociada a una frecuencia miccional diurna aumentada y nicturia, con o sin incontinencia urinaria, en ausencia de infección del tracto urinario u otra patología obvia", la OnanobotulinumtoxinA es una alternativa recomendable en caso de fracaso, intolerancia, contraindicación o rechazo del tratamiento conservador u otras alternativas terapéuticas no farmacológicas. La aplicación de TBA en detrusor se ha realizado bajo anestesia local, regional o general y como procedimiento en el quirófano convencional, quirófano de cirugía mayor ambulatoria o en sala de cistoscopias. El objetivo de este trabajo es describir el procedimiento para realizar el tratamiento con TBA de forma ambulante con anestesia local intravesical en la sala de cistoscopias, describiendo sus ventajas y limitaciones

Bladder hyperactivity is described as the presence of "voiding urgency, generally associated with increased daytime frequency and nocturia, with or without urinary incontinence, in the absence of urinary tract infection or other obvious pathology". Onabo-tulinum toxin A (BTA) is a recommendable therapeutic option in case of failure, contraindication or refusal of the conservative therapy or other non-pharmacological therapies. The injection of BTA in the detrusor has been performed under local, regional or general anesthesia either in the conventional or major ambulatory surgery operative room or in the cystoscopy room. The objective of this paper is to describe the procedure to perform BTA therapy as an ambulatory operation under intravesical local anesthesia in the cystoscopy room, describing its advantages and limitations