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 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.

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.

[Prostate biopsy: Diagnostic responsibility and recent changes]. / Biopsia prostática: responsabilidad diagnóstica y cambios recientes.

In this bibliographic review we reexamine the different features in relation to indication, performance and interpretation of prostatic biopsy (PB). The main objective is to place methodological features involving PB in the current scientific scenario, establishing the correlation between the most relevant and analyzing the historic evolution this procedure has followed, particularly over the last two decades. Prostate biopsy has evolved to be a regular element in urologists` daily practice and its learning process has been simplified to the point it can be approached with adequacy during the first years of residency in Urology. This privileged position PB enjoys in daily practice and the performance obtained from it would have not been a reality without optimization of transrectal ultrasound or local anesthesia techniques, yet reviled in some forums, the real responsible of such success. The consensus reached in the various scientific associations, the clinical guidelines of which are widely consulted worldwide, is the best to support the current state of the art, being the starting point for the addition of new improvements to PB.

Biopsia prostática: responsabilidad diagnóstica y cambios recientes / No disponible

En esta revisión bibliográfica se repasan los distintos aspectos relacionados con la indicación, realización e interpretación de la biopsia de próstata (BP).El objetivo principal es situar los aspectos metodológicos que rodean a la BP en el escenario científico actual, correlacionando entre sí los más relevantes y analizando la evolución histórica que este procedimiento ha seguido, particularmente, en las dos últimas décadas. La BP ha pasado a ser un elemento habitual en la práctica diaria del urólogo y su aprendizaje se ha simplificado hasta el punto de ser abordado con suficiencia durante los primeros años de la residencia en Urología. Esta posición privilegiada de que disfruta la BP en la práctica diaria y el rendimiento que de ella se obtiene, no hubiera sido una realidad sin la optimización de la ecografía transrectal ni las técnicas de anestesia local, aún denostadas en algunos foros, pero verdareros responsables de este éxito. El consenso adquirido en las diferentes asociaciones científicas cuyas guías clínicas son ampliamente consultadas en todo el mundo, es el mejor apoyo para afianzar el estado del arte actual y suponen el punto de partida a la incorporación de nuevas mejoras a la BP(AU)

In this bibliographic review we reexamine the different features in relation to indication, performance and interpretation of prostatic biopsy (PB).The main objective is to place methodological features involving PB in the current scientific scenario, establishing the correlation between the most relevant and analyzing the historic evolution this procedure has followed, particularly over the last two decades. Prostate biopsy has evolved to be a regular element in urologists` daily practice and its learning process has been simplified to the point it can be approached with adequacy during the first years of residency in Urology. This privileged position PB enjoys in daily practice and the performance obtained from it would have not been a reality without optimization of transrectal ultrasound or local anesthesia techniques, yet reviled in some forums, the real responsible of such success. The consensus reached in the various scientific associations, the clinical guidelines of which are widely consulted worldwide, is the best to support the current state of the art, being the starting point for the addition of new improvements to PB(AU)