Knowledge of professionals about sexuality of the ostomyzed.

BACKGROUND: An ostomy significantly influences a person's life, altering their biopsychosocial and sexual sphere and affecting their interpersonal relationships. MATERIALS AND METHODS: Through an observational, descriptive, and cross-sectional study, with a questionnaire aimed at professionals from a health area in Madrid, we analyzed: sociodemographic variables, knowledge of the professionals on the subject, referral of the patient according to the professional's assessment and feelings that the subject under study produces in the patient and in professionals. RESULTS: 49% claimed to have no knowledge about sexuality of the ostomyzed patients. 55.9% of those surveyed consider that the healthcare provider is the one who should introduce the topic of sexuality during the clinical interview. 48.5 and 85.2% are unaware of treatments for male and female sexual dysfunction, respectively. CONCLUSIONS: The data show that the training provided in the university centers is insufficient to deal effectively with this issue in the medical consultation. The participants manifest null or minimal knowledge about the sexual sphere in ostomized patients. Knowledge deficiencies are detected in relation to the sexuality of the ostomized patient, difficulty in talking about sex with these patients, and the importance that sanitary professionals give to the patient's sexual sphere, among others.

ANTECEDENTES: Una ostomía influye significativamente en la vida de la persona, alterando su esfera biopsicosocial y sexual, y afectando a sus relaciones interpersonales. MATERIAL Y MÉTODO: Estudio observacional, descriptivo y transversal. Mediante un cuestionario dirigido a profesionales de un área sanitaria de Madrid, se analizan variables sociodemográficas, conocimientos de los profesionales, derivación del paciente a un especialista según la valoración del profesional encuestado y sentimientos que produce en ellos el tema de estudio. RESULTADOS: El 49% afirma tener conocimientos nulos sobre la sexualidad del paciente ostomizado. El 55.9% de los encuestados considera que el sanitario es quien debe introducir el tema de la sexualidad durante la entrevista clínica. El 48.5 y el 85.2% desconocen tratamientos para la disfunción sexual, masculina y femenina, respectivamente. CONCLUSIÓN: Los datos demuestran que la formación impartida en los centros universitarios es insuficiente para tratar de forma efectiva este tema en la consulta. Los participantes en el estudio muestran nulo o mínimo conocimiento sobre la esfera sexualidad en el paciente ostomizado Se detectan deficiencias de conocimiento en relación con la sexualidad del ostomizado, dificultad para hablar de sexo con el paciente y valor que da el profesional a la esfera sexual en su paciente, entre otras.

Mirabegron Vs Placebo Add-on Therapy in Men With Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the Randomized, Phase 4 PLUS Study.

OBJECTIVE: To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia. METHODS: The Phase 4 PLUS study comprised a 4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo). Doses were increased to mirabegron 50 mg or matched placebo after 4 weeks. Safety assessments: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms, and changes in postvoid residual volume and maximum urinary flow (Qmax). RESULTS: The safety analysis set included 352 tamsulosin plus mirabegron (TAM + MIRA) and 354 tamsulosin plus placebo (TAM + PL) patients. The frequency of overall TEAEs was higher with TAM + PL, although a higher incidence of drug-related TEAEs was observed with TAM + MIRA. Most TEAEs were mild or moderate in severity. Drug-related serious TEAEs were reported for 3 patients (2 TAM + MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, 1 TAM + PL patient: lacunar stroke). Hypertension, headache, and nasopharyngitis were the most common TEAEs. Special interest TEAEs were infrequently reported. The most common was urinary retention and 2 TAM + MIRA patients required catheterization (neither led to discontinuation). No major changes in blood pressure or pulse rate were noted and similar electrocardiogram parameters were observed for both groups. Changes in mean postvoid residual volume and Qmax were not clinically meaningful. CONCLUSION: No unexpected safety concerns were noted in men receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia who subsequently received mirabegron add-on therapy.

[IPSS storage score as a predictive tool of quality of life improvement to apply in therapeutic interventions.] / El IPSS de llenado como herramienta predictiva de la mejoría en la calidad de vida aplicable en intervenciones terapéuticas.

OBJECTIVES: The questionnaire International Prostate Symptom Score (IPSS) is well known and used in clinical practice as diagnostic tool and allows for obtaining a total score regarding the severity of the urinary symptoms. The objective of this analysis is to determine if the IPSS storage score (sum of the punctuation of the questions 2, 4 and 7) could be a predictive variable of the impact on quality of life. MATERIALS AND METHODS: Post-hoc analysis of an epidemiological, multicenter, cross-sectional study inmale patients, ≥18 years old with ≥6 micturitions and≥1 urgency and/or ≥2 nocturia and/or ≥1 daily incontinence episodes recruited by 291 urologists across Spain. Socio demographic variables, symptoms reported by patients (IPSS) and clinical variables were collected. The impact of voiding symptoms (IPSS-V) and storage symptoms (IPSS-S) on the quality of life, measured using the Overactive Bladder questionnaire Short Form(OABq-SF HRQoL), was evaluated using multivariate regression models (linear and logistic). RESULTS: 958 patients, whose mean score (standard deviation) of the OABq-SF HRQoL was 57.9 (18.3),were included in the study. 55.6% received drug treatment for urinary symptoms. 616 patients (64.4%) reported a puntuation >3 in the item 8 of the IPSS. The adjusted analysis showed a significant reduction in the qualityof life of -1.1 (p<0.001) and -3.3 (p<0.001) points associated with the worsening of the symptoms of voiding and storage respectively. This worsening was also associated with a minor risk of satisfaction (OR=1.14;p<0.001 and 1.36; p<0.001) for the voiding and storage symptoms respectively. CONCLUSION: In patients with mixed LUTS both components show a negative effect on the quality of life, with a greater impact of the storage symptoms.

OBJETIVOS:  El cuestionario Escala Internacionalde Síntomas Prostáticos (IPSS) es ampliamente utilizado en clínica como herramienta diagnóstica y permite obtener una puntuación total aportando información sobre la severidad de los síntomas urinarios. El objetivo de este análisis es determinar si la puntuación del IPSS de llenado (suma de la puntuación de las preguntas 2, 4 y 7) puede ser una variable predictora del impacto en la calidad de vida.MATERIALES Y MÉTODOS: Análisis post-hoc de un estudio epidemiológico, multicéntrico, transversal en pacientes varones, ≥18 años, ≥6 micciones, ≥1 episodios de urgencia y/o ≥2 nicturias y/o ≥1 episodio de incontinencia diarios, reclutados por 291 urólogosen España. Se recogieron variables sociodemográficas, síntomas reportados por pacientes (IPSS) y variables clínicas.Se ha evaluado el impacto de la sintomatología de vaciado (IPSS-V) y llenado (IPSS-S) en la calidad de vida, medida con la Versión Corta del Cuestionario de Vejiga Hiperactiva (OABq-SF HRQoL), y a través del ítem 8 del cuestionario IPSS (IPSS-8), mediante modelos de regresión multivariante lineal y logística. RESULTADOS: Se incluyeron 958 pacientes con una puntuación media (desviación estandar) de la escala OABq-SF HRQoL de 57,9 (18,3). 55,6% recibieron tratamiento médico para síntomas urinarios. 616 pacientes (64,4%) tuvieron una puntuación >3 en IPSS-8. El análisis ajustado mostró una reducción significativa en calidad de vida de -1,1 (p<0,01) y -3,3 (p<0,001) puntos asociada al empeoramiento de síntomas de vaciado y llenado, respectivamente. Este empeoramiento se asoció a menor satisfacción (OR=1,14; p<0,001 y 1,36; p<0,001) para síntomas de vaciado y llenado, prespectivamente. CONCLUSIONES: En pacientes con STUI mixtos, ambos componentes muestran un efecto negativo sobre la calidad de vida, siendo superior el impacto de los síntomas de llenado.

El IPSS de llenado como herramienta predictiva de la mejoría en la calidad de vida aplicable en intervenciones terapéuticas / IPSS storage score as a predictive tool of quality of life improvement to apply in therapeutic interventions

OBJETIVOS: El cuestionario Escala Internacionalde Síntomas Prostáticos (IPSS) es ampliamente utilizado en clínica como herramienta diagnóstica y permite obtener una puntuación total aportando información sobre la severidad de los síntomas urinarios. El objetivo de este análisis es determinar si la puntuación del IPSS de llenado (suma de la puntuación de las preguntas 2, 4 y 7) puede ser una variable predictora del impacto en la calidad de vida. MATERIALES Y MÉTODOS: Análisis post-hoc de un estudio epidemiológico, multicéntrico, transversal en pacientes varones, ≥ 18 años, ≥ 6 micciones, ≥ 1 episodios de urgencia y/o ≥ 2 nicturias y/o ≥ 1 episodio de incontinencia diarios, reclutados por 291 urólogosen España. Se recogieron variables sociodemográficas, síntomas reportados por pacientes (IPSS) y variables clínicas. Se ha evaluado el impacto de la sintomatología de vaciado (IPSS-V) y llenado (IPSS-S) en la calidad de vida, medida con la Versión Corta del Cuestionario de Vejiga Hiperactiva (OABq-SF HRQoL), y a través del ítem 8 del cuestionario IPSS (IPSS-8), mediante modelos de regresión multivariante lineal y logística. RESULTADOS: Se incluyeron 958 pacientes con una puntuación media (desviación estandar) de la escala OABq-SF HRQoL de 57,9 (18,3). 55,6% recibieron tratamiento médico para síntomas urinarios. 616 pacientes (64,4%) tuvieron una puntuación > 3 en IPSS-8. El análisis ajustado mostró una reducción significativa en calidad de vida de -1,1 (p < 0,01) y -3,3 (p < 0,001) puntos asociada al empeoramiento de síntomas de vaciado y llenado, respectivamente. Este empeoramiento se asoció a menor satisfacción (OR = 1,14; p < 0,001 y 1,36; p < 0,001) para síntomas de vaciado y llenado, prespectivamente. CONCLUSIONES: En pacientes con STUI mixtos, ambos componentes muestran un efecto negativo sobre la calidad de vida, siendo superior el impacto de los síntomas de llenado

OBJECTIVES: The questionnaire International Prostate Symptom Score (IPSS) is well known and used in clinical practice as diagnostic tool and allows for obtaining a total score regarding the severity of the urinary symptoms. The objective of this analysis is to determine if the IPSS storage score (sum of the punctuation of the questions 2, 4 and 7) could be a predictive variable of the impact on quality of life. MATERIALS AND METHODS: Post-hoc analysis of an epidemiological, multicenter, cross-sectional study inmale patients, ≥ 18 years old with ≥ 6 micturitions and ≥ 1 urgency and/or ≥ 2 nocturia and/or ≥ 1 daily incontinence episodes recruited by 291 urologists across Spain. Socio demographic variables, symptoms reported by patients (IPSS) and clinical variables were collected. The impact of voiding symptoms (IPSS-V) and storage symptoms (IPSS-S) on the quality of life, measured using the Overactive Bladder questionnaire Short Form(OABq-SF HRQoL), was evaluated using multivariate regression models (linear and logistic). RESULTS: 958 patients, whose mean score (standard deviation) of the OABq-SF HRQoL was 57.9 (18.3),were included in the study. 55.6% received drug treatment for urinary symptoms. 616 patients (64.4%) reported a puntuation > 3 in the item 8 of the IPSS. The adjusted analysis showed a significant reduction in the qualityof life of -1.1 (p < 0.001) and -3.3 (p < 0.001) points associated with the worsening of the symptoms of voiding and storage respectively. This worsening was also associated with a minor risk of satisfaction (OR = 1.14; p < 0.001 and 1.36; p < 0.001) for the voiding and storage symptoms respectively. CONCLUSION: In patients with mixed LUTS both components show a negative effect on the quality of life, with a greater impact of the storage symptoms

Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).

PURPOSE: PLUS investigated the efficacy and safety of mirabegron add-on therapy in men with overactive bladder symptoms receiving tamsulosin for underlying lower urinary tract symptoms attributable to benign prostatic hyperplasia. MATERIALS AND METHODS: In this phase 4 study a 4-week 0.4 mg tamsulosin run-in period was followed by a 12-week, randomized, double-blind, treatment period in which patients initially received 25 mg mirabegron or placebo add-on therapy. At 4 weeks doses were titrated to 50 mg mirabegron or placebo equivalent. Efficacy end points were changes from baseline to end of treatment in mean number of micturitions per day (primary), mean volume voided per micturition, number of urgency episodes per day, total urgency and frequency score, and total International Prostate Symptom Score (secondary). Safety assessments included treatment emergent adverse events, and post-void residual volume, and maximum urinary flow measurements. RESULTS: Of the 676 men most were 65 years old or older (380, 56.2%). Tamsulosin plus mirabegron was statistically superior to tamsulosin plus placebo in reducing the mean number of micturitions per day (-2.00 vs -1.62; adjusted difference -0.39; 95% CI -0.76, -0.02). Statistically superior results were noted for tamsulosin plus mirabegron in mean volume voided per micturition, urgency episodes per day, and total urgency and frequency score (not International Prostate Symptom Score). Higher overall treatment emergent adverse event rates were observed with tamsulosin plus placebo, although higher rates of drug related treatment emergent adverse events were noted with tamsulosin plus mirabegron. Urinary retention rates were higher in the tamsulosin plus mirabegron group. Post-void residual volume and maximum urinary flow results were not clinically meaningful. CONCLUSIONS: The results of PLUS underscore the utility of mirabegron add-on therapy to treat men with overactive bladder symptoms receiving tamsulosin for benign prostatic hyperplasia.

Cardiovascular safety in refractory incontinent patients with overactive bladder receiving add-on mirabegron therapy to solifenacin (BESIDE).

AIMS/OBJECTIVES: In the BESIDE study, combination therapy (antimuscarinic [solifenacin] and ß3 -adrenoceptor agonist [mirabegron]) improved efficacy over solifenacin monotherapy without exacerbating anticholinergic side effects in overactive bladder (OAB) patients; however, a potential synergistic effect on the cardiovascular (CV) system requires investigation. METHODS: OAB patients remaining incontinent despite daily solifenacin 5 mg during 4-week single-blind run-in, were randomised 1:1:1 to double-blind daily combination (solifenacin 5 mg/mirabegron 25 mg, increasing to 50 mg after week 4), solifenacin 5 or 10 mg for 12 weeks. CV safety assessments included frequency of CV-related treatment-emergent adverse events (TEAEs), change from baseline in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate) and electrocardiogram (ECG) parameters. RESULTS: The frequency of hypertension, tachycardia and ECG QT prolongation, respectively, was low and comparable across combination (1.1%, 0.3%, 0.1%), solifenacin 5 mg (0.7%, 0.1%, 0.1%), and solifenacin 10 mg groups (0.8%, 0%, 0.1%). Adjusted mean (SE) change from baseline to end of treatment (EoT) in SBP, DBP, and pulse rate with combination (0.07 mm Hg [0.38], -0.35 mm Hg [0.26], 0.47 bpm [0.28]), solifenacin 5 mg (-0.93 mm Hg [0.38], -0.45 mm Hg [0.26], 0.43 bpm [0.28]) and solifenacin 10 mg (-1.28 mm Hg [0.38], -0.48 mm Hg [0.26], 0.27 bpm [0.28]) was generally comparable, with the exception of a mean treatment difference of ~1 mm Hg in SBP between combination and solifenacin monotherapy; SBP was unchanged with combination and decreased with solifenacin monotherapy. Mean changes from baseline to EoT in ECG parameters were generally similar across treatment groups, except for QT interval corrected using Fridericia's formula, which was higher with solifenacin 10 mg (3.30 mseconds) vs. combination (0.49 mseconds) and solifenacin 5 mg (0.77 mseconds). CONCLUSION: The comparable frequency of CV-related TEAEs, changes in vital signs and ECG parameters indicates no synergistic effect on CV safety outcomes when mirabegron and solifenacin are combined.

[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

Solifenacina: evidencia científica en el tratamiento de la vejiga hiperactiva / Solifenacin: Scientific evidence in the treatment of overative bladder

OBJETIVO: En este artículo se pretende analizar el uso de solifenacina en el tratamiento de la vejiga hiperactiva para objetivar su eficacia y seguridad dentro del marco de la evidencia científica.MÉTODOS: Se ha revisado la literatura científica disponible incluyendo la mayoría de los ensayos clínicos relevantes realizados con solifenacina.RESULTADOS: En todos los estudios analizados se aprecian mejorías significativas en los pacientes tratados con solifenacina respecto al placebo y tolterodina. Los parámetros de eficacia han sido valorados en términos objetivos y subjetivos, haciendo hincapié en la calidad de vida. El 60% de los pacientes mejoran su urgencia (40% no reportan urgencia), el 58% recuperan la continencia y el 69% perciben mejoría en su condición vesical. Tras finalizar el tratamiento el 80% se encuentran satisfechos con los resultados y el 79% están dispuestos a continuarlo a largo plazo.CONCLUSIONES: La solifenacina es eficaz en el tratamiento de la vejiga hiperactiva. La posibilidad de encontrar la dosis más eficaz, tolerable y con mejor respuesta en términos de calidad de vida supone una diferencia importante respecto a otros antimuscarínicos. El aumento a 10 mg supone mejorías adicionales en cuanto a eficacia sin suponer un aumento significativo en los efectos adversos. Los efectos secundarios percibidos fueron leves o moderados en la mayoría de los casos, no suponiendo más abandonos de tratamiento que en el grupo de placebo. La mayoría de pacientes se sienten conformes con el tratamiento y están dispuestos a prolongarlo en el tiempo(AU)

OBJECTIVES: This article aims to analyse the use of solifenacin in the treatment of overactive bladder in order to show its efficacy and safety within the framework of the scientific evidence.METHODS: The available scientific literature was reviewed, including most of the relevant clinical trials performed with solifenacin.RESULTS: All the studies analysed show significant improvements in patients treated with solifenacin versus placebo and tolterodine. Efficacy parameters were assessed in objective and subjective terms, with particular emphasis placed on quality of life. Urgency improves in 60% of patients (40% report no urgency), 58% of patients get continence and 69% perceive an improvement in bladder condition. On completion of treatment, 80% are satisfied with the results and 79% are willing to continue with the treatment in the long term.CONCLUSIONS: Solifenacin is efficacious in the treatment of overactive bladder. The possibility of finding the most effective and tolerable dose with the best response in terms of quality of life constitutes an important difference with regard to other antimuscarinics. The increase to 10 mg gets additional improvements in terms of efficacy, without a significant increase in adverse effects. The side effects perceived were mild or moderate in most cases, and did not lead to more withdrawals compared to placebo. Most patients were satisfied with the treatment and are willing to stay on it in the long term(AU)