Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study.

The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.

Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study.

We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group (p = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively (p < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.

Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients.

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Clinical Benefit of Tamsulosin and the Hexanic Extract of Serenoa Repens, in Combination or as Monotherapy, in Patients with Moderate/Severe LUTS-BPH: A Subset Analysis of the QUALIPROST Study.

To investigate whether tamsulosin (TAM) and the hexanic extract of Serenoa repens (HESr) are more effective in combination than as monotherapy in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Subset analysis of data from a 6-month, multicenter observational study. Patients received either tamsulosin (0.4 mg/day) or HESr (320 mg/day) alone or in combination. Primary endpoints were change in symptoms and quality of life. Tolerability was also assessed. Seven hundred and nine patients were available for intention to treat (ITT) analysis, 263 treated with tamsulosin, 262 with HESr, and 184 with TAM + HESr. After 6 months, International Prostate Symptom Score (IPSS) scores improved by a mean (standard deviation) of 7.2 (5.0) points in the TAM + HESr group compared to 5.7 (4.3) points with TAM alone and 5.4 (4.6) points with HESr (p < 0.001). Quality of life showed greatest improvement with combination therapy (p < 0.02). Adverse effects were reported by 1.9% of patients receiving HESr, 13.3% receiving TAM, and 12.0% receiving TAM + HESr (p < 0.001). In men with moderate/severe LUTS/BPH, combination treatment with TAM + HESr produced more effective symptom relief and greater improvement in quality of life than with either treatment alone, with acceptable tolerability.

[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

Quality of life in patients with lower urinary tract symptoms associated with BPH: change over time in real-life practice according to treatment--the QUALIPROST study.

PURPOSE: To evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice. METHODS: Prospective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics. Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥ 8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS. RESULTS: 1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16.8 (5.4) and 6.8 (2.6), respectively. 8.9 % (n = 153) of study participants did not receive treatment (watchful waiting, WW), 70.3 % (n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95.2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20.8 % (n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2.4 points [2.4]; PT: 1.9 [2.4]; 5ARI: 2.5 [2.3]) and combined therapy (AB + 5ARI: 3.1 [2.9]; AB + PT: 3.1 [2.5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW (p < 0.05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar. CONCLUSIONS: Improvements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.

Documento de consenso sobre vejiga hiperactiva en el paciente mayor / Consensus document on overactive bladder in older patients

La vejiga hiperactiva (VH) es una entidad clínica con una elevada prevalencia en la población mayor, generando un gran impacto en la calidad de vida, sobre todo cuando se presenta con incontinencia urinaria de urgencia. Es importante destacar el bajo índice de consulta por esta entidad en la población mayor, influyendo diferentes factores (educacionales, culturales, profesionales), lo cual condiciona un bajo porcentaje de pacientes mayores que reciban un tratamiento adecuado y por el contrario un gran porcentaje de pacientes mayores con deterioro considerable de su calidad de vida. Por ello, las Sociedades científicas y los Grupos de Trabajo proponen en sus documentos y guías clínicas la detección precoz de la VH. Su etiología no está bien aclarada, relacionándose con procesos vasculares cerebrales y otros problemas neurológicos, con alteraciones del músculo detrusor y de los receptores vesicales, y procesos obstructivos e inflamatorios del tracto urinario inferior. El diagnóstico de la VH es clínico, pudiéndose establecer en la gran mayoría de los casos su diagnóstico y orientación etiopatogénica sin la necesidad de utilizar procedimientos diagnósticos complejos. Actualmente existen tratamientos altamente efectivos para la VH, debiendo decidir de forma individualizada el más adecuado para cada paciente mayor, en base a sus características. Las distintas Guías de buena práctica clínica aconsejan un tratamiento escalonado, siendo los antimuscarínicos el tratamiento farmacológico más recomendado. Por todo ello, un grupo de profesionales muy implicados en la práctica asistencial de personas mayores, y representando a 2 Sociedades científicas (Sociedad Española de Geriatría y Gerontología [SEGG] y la Sociedad Española de Médicos de Atención Primaria [SEMERGEN]), han desarrollado este documento de consenso con el objetivo fundamental de establecer estrategias prácticas y válidas enfocadas a facilitar el manejo de esta entidad clínica en la población mayor y mejorar así su calidad de vida. Las recomendaciones que se presentan en este consenso son el resultado de una amplia revisión y discusión crítica de los artículos, documentos y guías clínicas sobre VH, tanto a nivel nacional como internacional. Se han incluido, cuando ha sido posible, los niveles de evidencia y grados de recomendación (AU)

Overactive nladder (OAB) is a clinical entity with a high prevalence in the population, having a high impact on quality of life, especially when it occurs with urge urinary incontinence. It is very important to highlight the low rate of consultation of this condition by the older population. This appears to depend on several factors (educational, cultural, professional), and thus leads to the low percentage of older patients who receive appropriate treatment and, on the other hand, a large percentage of older patients with a significant deterioration in their quality of life. Therefore, Scientific societies and Working Groups propose the early detection of OAB in their documents and clinical guidelines. Its etiology is not well known, but is influenced by cerebrovascular processes and other neurological problems, abnormalities of the detrusor muscle of bladder receptors, and obstructive and inflammatory processes of the lower urinary tract. Its diagnosis is clinical, and in the great majority of the cases it can be possible to establish its diagnosis and etiopathogenic orientation, without the need for complex diagnostic procedures. Currently, there are effective treatments for OAB, and we should decide the most appropriate for each elderly patient, based on their individual characteristics. Based on the main clinical practice guidelines, a progressive treatment is proposed, with the antimuscarinics being the most recommended drug treatment. Therefore, a group of very involved professionals in clinical practice for the elderly, and representing two scientific Societies (Spanish Society of Geriatrics and Gerontology [SEGG], and the Spanish Society of Primary Care Physicians [SEMERGEN]) developed this consensus document with the main objective of establishing practices and valid strategies, focused to simplify the management of this clinical entity in the elderly population, and especially to improve their quality of life. The recommendations presented in this consensus document are the result of a comprehensive review and critical discussion of articles, documents and clinical guidelines on OAB, both nationally and internationally. Are, where possible, levels of evidence and grades of recommendation are included (AU)

[Consensus document on overactive bladder in older patients]. / Documento de consenso sobre vejiga hiperactiva en el paciente mayor.

Overactive nladder (OAB) is a clinical entity with a high prevalence in the population, having a high impact on quality of life, especially when it occurs with urge urinary incontinence. It is very important to highlight the low rate of consultation of this condition by the older population. This appears to depend on several factors (educational, cultural, professional), and thus leads to the low percentage of older patients who receive appropriate treatment and, on the other hand, a large percentage of older patients with a significant deterioration in their quality of life. Therefore, Scientific societies and Working Groups propose the early detection of OAB in their documents and clinical guidelines. Its etiology is not well known, but is influenced by cerebrovascular processes and other neurological problems, abnormalities of the detrusor muscle of bladder receptors, and obstructive and inflammatory processes of the lower urinary tract. Its diagnosis is clinical, and in the great majority of the cases it can be possible to establish its diagnosis and etiopathogenic orientation, without the need for complex diagnostic procedures. Currently, there are effective treatments for OAB, and we should decide the most appropriate for each elderly patient, based on their individual characteristics. Based on the main clinical practice guidelines, a progressive treatment is proposed, with the antimuscarinics being the most recommended drug treatment. Therefore, a group of very involved professionals in clinical practice for the elderly, and representing two scientific Societies (Spanish Society of Geriatrics and Gerontology [SEGG], and the Spanish Society of Primary Care Physicians [SEMERGEN]) developed this consensus document with the main objective of establishing practices and valid strategies, focused to simplify the management of this clinical entity in the elderly population, and especially to improve their quality of life. The recommendations presented in this consensus document are the result of a comprehensive review and critical discussion of articles, documents and clinical guidelines on OAB, both nationally and internationally. Are, where possible, levels of evidence and grades of recommendation are included.

Utilidad de los alfa-bloqueantes en el tratamiento de distintos trastornos urológicos / Update of the usefulness of alpha-blockers in the treatment of different urologic pathologies

Objetivo. Revisar el papel de los alfa-bloqueantes en distintos trastornos urológicos como son la hipertrofia benigna de próstata, la vejiga hiperactiva, la prostatitis crónica, la disfución eréctil y el tratamiento expulsivo de la litiasis ureteral distal. Material y método. Se revisa la evidencia científica más actual en todos los campos anteriormente citados, haciéndose un análisis crítico de los mismos. Conclusiones. Los alfa-bloqueantes se consideran en la actualidad el tratamiento de primera elección en los síntomas del tracto urinario inferior secundarios al crecimiento prostático benigno, pero sus indicaciones van más allá, pudiendo mejorar solos o en adyuvancia con otros fármacos los procesos patológicos anteriormente citados. La uroselectividad de alguno de ellos les hace que tengan una seguridad muy alta en su utilización(AU)

Objective. To review the role of alpha-blockers in various urological conditions such as benign prostatic hyperplasia, overactive bladder, chronic prostatitis, and erectile dysfunction and as expulsive treatment of distal ureteral stones. Material and methods. We reviewed the latest scientific evidence in all the fields mentioned above, performing a critical analysis. Conclusion. alpha-blockers are now considered first-line treatment in lower urinary tract symptoms secondary to benign prostatic hyperplasia, but the indications go beyond, and are able to improve, alone or in combination with other drugs, the previously mentioned pathologies. The uroselective properties of some alpha-blockers make them a highly safe medication(AU)

[Update of the usefulness of α-blockers in the treatment of different urologic pathologies]. / Utilidad de los alfa-bloqueantes en el tratamiento de distintos trastornos urológicos.

OBJECTIVE: To review the role of α-blockers in various urological conditions such as benign prostatic hyperplasia, overactive bladder, chronic prostatitis, and erectile dysfunction and as expulsive treatment of distal ureteral stones. MATERIAL AND METHODS: We reviewed the latest scientific evidence in all the fields mentioned above, performing a critical analysis. CONCLUSION: α-blockers are now considered first-line treatment in lower urinary tract symptoms secondary to benign prostatic hyperplasia, but the indications go beyond, and are able to improve, alone or in combination with other drugs, the previously mentioned pathologies. The uroselective properties of some α-blockers make them a highly safe medication.

Criterios de derivación en hiperplasia benigna de próstata para atención primaria / Referral criteria for benign prostatic hyperplasia in primary care

La hiperplasia benigna de próstata (HPB) es una enfermedad con alta prevalencia entre los varones de más de 50 años que requiere una continuidad asistencial entre los 2 niveles existentes en nuestro país, el de atención primaria (AP) y el de atención especializada; motivo por el que era necesario consensuar unos criterios de derivación o de continuidad que sirvan de orientación a ambos colectivos. La historia clínica del paciente, el Índice Internacional de Síntomas Prostáticos (IPSS, International Prostate Symptom Score), el tacto rectal y el antígeno prostático específico (PSA, prostate-specific antigen) son herramientas accesibles en el ámbito de la AP que permiten un diagnóstico adecuado de la HBP. Conscientes de tal necesidad, las sociedades científicas de atención primaria (Sociedad Española de Médicos de Atención Primaria [SEMERGEN], Sociedad Española de Medicina General [SEMG] y Sociedad Española de Medicina de Familia y Comunitaria [semFYC]) y la Asociación Española de Urología (AEU) elaboraron este documento de consenso. A los pacientes con IPSS<8 se los deberá mantener en vigilancia y evaluar anualmente; en los pacientes con IPSS 8-20, si el tamaño de la próstata es pequeño, se recomienda el tratamiento con bloqueadores alfa y evaluación al primer y tercer mes, si el tamaño de la próstata es grande se recomienda el tratamiento con bloqueadores alfa o inhibidores de la 5-alfa-reductasa y evaluación al tercery sexto mes, y en el caso de pacientes con próstata grande y PSA 41,5 ng/ml se recomienda el tratamiento combinado y la evaluación al primer y sexto mes. En este documento se establecen unos criterios de derivación al urólogo claros, que facilitan el tratamiento de este tipo de pacientes. Se derivarán al urólogo aquellos pacientes con HBP que no presenten mejoría al tercer mes de tratamiento con bloqueadores alfa, o al sexto mes de tratamiento con inhibidores de la 5-alfa-reductasa(AU)

Se derivarán también los pacientes con síntomas del tracto urinario inferior en los que se observe algún hallazgo patológico durante el tacto rectal, IPSS >20, PSA >10 ng/ml o PSA >4 ng/ml y PSA libre <20% o pacientes con edades < 50 años y sospecha de HBP, así como aquellos pacientes con alguna complicación urológica(AU)

Benign prostatic hyperplasia (BPH) is a high prevalence condition in men over 50 years that requires continued assistance between primary care and urology. Therefore, consensus around common referral criteria was needed to guide and support both levels. Medical history, symptom assessment with International Prostate Symptom Score (IPSS) questionnaire, digital rectal examination and prostate-specific antigen (PSA) measurement are diagnostic tests available for general practitioners that allow setting a correct BPH diagnose. Patients with an IPSS<8 should be monitored by evaluating them annually. Treatment with α-blockers and an evaluation at the first and third month is recommended in patients with an IPSS 8-20 and if the prostate is small, if the prostate size is large treatment with α-blockers or 5α-reductase inhibitors and evaluation at the third and six month is recommended, and in patients with a large prostate and a PSA >1.5ng/ml combined treatment and evaluation at the first and sixth month is recommended. Some clear criteria for referral to urology are established in this document, which help in the management of these patients. Those patients with BPH who do not show any improvement at the third month of treatment with α-blockers, or the sixth month with 5α-reductase inhibitors, will be referred to urology. Patients will also be referred to urology if they have lower urinary tract symptoms, a pathological finding during rectal examination, IPSS>20, PSA>10ng/ml or PSA>4ng/ml and free PSA<20% or if they are <50 years with suspected BHP, or if they have any urological complication(AU)

[Referral criteria for benign prostatic hyperplasia in primary care]. / Criterios de derivación en hiperplasia benigna de próstata para atención primaria.

Benign prostatic hyperplasia (BPH) is a high prevalence condition in men over 50 years that requires continued assistance between primary care and urology. Therefore, consensus around common referral criteria was needed to guide and support both levels. Medical history, symptom assessment with International Prostate Symptom Score (IPSS) questionnaire, digital rectal examination and prostate-specific antigen (PSA) measurement are diagnostic tests available for general practitioners that allow setting a correct BPH diagnose. Patients with an IPSS<8 should be monitored by evaluating them annually. Treatment with alpha-blockers and an evaluation at the first and third month is recommended in patients with an IPSS 8-20 and if the prostate is small, if the prostate size is large treatment with alpha-blockers or 5alpha-reductase inhibitors and evaluation at the third and six month is recommended, and in patients with a large prostate and a PSA >1.5 ng/ml combined treatment and evaluation at the first and sixth month is recommended. Some clear criteria for referral to urology are established in this document, which help in the management of these patients. Those patients with BPH who do not show any improvement at the third month of treatment with alpha-blockers, or the sixth month with 5alpha-reductase inhibitors, will be referred to urology. Patients will also be referred to urology if they have lower urinary tract symptoms, a pathological finding during rectal examination, IPSS>20, PSA>10 ng/ml or PSA>4 ng/ml and free PSA<20% or if they are <50 years with suspected BHP, or if they have any urological complication.

[Diagnosis and management of patients with overactive bladder syndrome in urology clinics and general practitioner clinics in Spain]. / Diagnóstico y manejo de pacientes con síndrome de vejiga hiperactiva en las consultas de urología y atención primaria en España.

OBJECTIVES: Despite its high prevalence and its important impact on patient's life, overactive bladder is a disorder poorly known and not usually tackled in daily clinical practice. The aim of this study is to know the main procedures and techniques used by both urologists and general practitioners to diagnose overactive bladder in usual clinical practice in Spain. METHODS: A standardized questionnaire was administered to 748 physicians specialized in urology and to 696 primary core physicians or general practitioners. The questionnaire collected information about the management of patients who attended surgery with urinary symptoms suggesting overactive bladder. RESULTS: A total of 64.8% of urologists argued they followed a standardized protocol in order to diagnose patients suffering from overactive bladder. Concerning primary care physicians, 58.4% of them admitted not referring patients with urinary symptoms suggesting overactive bladder to specialist. Up to 77.8% of urologists confirmed that referred patients from primary care had no previous exam or diagnosis. Health history, physical examination and urinalysis were the usual diagnosis procedures in clinical practice conditions for both specialities. Other instruments such as the micturition diary or the questionnaires to assess symptoms or patients' quality of life are still little used for the diagnosis and management of overactive bladder. CONCLUSIONS: Although overactive bladder is a condition that causes a high impairment in the quality of life (QoL) and daily activities of those patients suffering from it, it still remains poorly tackled by doctors. Therefore, it is important to define strategies to detect its symptoms in the clinical practice.

Diagnóstico y manejo de pacientes con síndrome de vejiga hiperactiva en las consultas de urología y atención primaria en España / Diagnosis and management of patients with overactive bladder syndrome in urology clinics and general practitioner clinics in Spain

OBJETIVOS: El Síndrome de Vejiga Hiperactiva (SVH), a pesar de presentar una elevada prevalencia y un impacto importante en la vida del paciente, es un trastorno mal conocido y poco abordado en la práctica asistencial. El objetivo del estudio es conocer las diferentes técnicas y procedimientos empleados en el diagnóstico de SVH, tanto por urólogos como por médicos de atención primaria (AP), en condiciones de práctica clínica habitual en España. METODOS: Se administró un cuestionario estandarizado a 748 médicos especialistas en urología y 696 médicos de AP. Dicho cuestionario recogía información sobre el manejo de los pacientes que acudían a su consulta con síntomas urinarios sugestivos de SVH. RESULTADOS: Un 64,8% de los urólogos afirmaron seguir algún protocolo estandarizado para el diagnóstico de pacientes con SVH. Un 58,4% de los médicos de AP afirmaron no derivar a los pacientes con síntomas urinarios sugestivos de SVH. Un 77,8% de los urólogos afirmaron que los pacientes que venían derivados desde AP llegaban sin ningún diagnóstico ni estudio previo. En ambas especialidades la historia clínica, la exploración física y el análisis de orina son procedimientos que forman parte de la práctica diagnóstica habitual. Otras medidas como son el diario miccional y los cuestionarios de síntomas o de evaluación de la calidad de vida son aún poco utilizados en el diagnóstico y manejo del SVH. CONCLUSIONES: Si bien el SVH es una condición que conlleva una gran afectación de la Calidad de Vida (CdV) y de las actividades diarias de los pacientes que lo padecen, todavía está poco abordada desde el punto de vista asistencial. Es importante establecer estrategias de detección de los síntomas en la práctica clínica (AU)

OBJECTIVES: Despite its high prevalence and its important impact on patient's life, overactive bladder is a disorder poorly known and not usually tackled in daily clinical practice. The aim of this study is to know the main procedures and techniques used by both urologists and general practitioners to diagnose overactive bladder in usual clinical practice in Spain. METHODS: A standardized questionnaire was administered to 748 physicians specialized in urology and to 696 primary core physicians or general practitioners. The questionnaire collected information about the management of patients who attended surgery with urinary symptoms suggesting overactive bladder. RESULTS: A total of 64.8% of urologists argued they followed a standardized protocol in order to diagnose patients suffering from overactive bladder. Concerning primary care physicians, 58.4% of them admitted not referring patients with urinary symptoms suggesting overactive bladder to specialist. Up to 77.8% of urologists confirmed that referred patients from primary care had no previous exam or diagnosis. Health history, physical examination and urinalysis were the usual diagnosis procedures in clinical practice conditions for both specialities. Other instruments such as the micturition diary or the questionnaires to assess symptoms or patients' quality of life are still little used for the diagnosis and management of overactive bladder. CONCLUSIONS: Although overactive bladder is a condition that causes a high impairment in the quality of life (QoL) and daily activities of those patients suffering from it, it still remains poorly tackled by doctors. Therefore, it is important to define strategies to detect its symptoms in the clinical practice