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.

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.