Efficacy and safety of a hexanic extract of Serenoa repens (Permixon® ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies.

OBJECTIVES: To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon® ; Pierre Fabre Médicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (≥1 year). RESULTS: Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/night (P < 0.001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with α-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5α-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for ≥1 year (n = 447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). CONCLUSION: The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Qmax compared with placebo and had a similar efficacy to tamsulosin and short-term 5-ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the long-term medical treatment of LUTS/BPH.

Listening to the patient: a flexible approach to the use of antimuscarinic agents in overactive bladder syndrome.

Several studies with modern antimuscarinics have used a flexible-dosing strategy. We reviewed data from several studies with solifenacin, darifenacin and oxybutynin extended-release that evaluated the impact of dose flexibility on clinical management. A strategy based on patient-requested dose increases was found to be consistently effective in improving the symptoms of overactive bladder. Patients requesting a dose increase often had more severe symptoms at baseline than those who did not request a dose increase, and these patients derived most benefit from the increased dose. Specialists and family doctors should encourage open discussion with their patients about requesting dose titration so as to meet patients' individual needs.

[Psychometric validation of the OAB-V8 and OAB-V3 scales for the screening of patients with probable overactive bladder in the Spanish population]. / Validación psicométrica de las escalas OAB-V8 y OAB-V3 para la detección de pacientes con probable vejiga hiperactiva en la población española.

BACKGROUND AND OBJECTIVE: To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB). PATIENTS AND METHODS: A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity. Subjects were classified according to the likelihood of OAB, using an automated algorithm validated previously. ROC curve analysis was performed, and the sensitivity, specificity, and positive and negative predictive values were also assessed. RESULTS: A total of 2,035 subjects with a mean+SD age of 52.7+12.1 years were included (50.8%) men. In total 13.7% were classified as «Probable¼, 27.9% «Possible¼, and 58.3% «No¼ OAB. The internal consistency of both OAB-V8 and OAB-V3 scales was high (0.894 and 0.851, respectively). The item-total correlation coefficients were high; 0.87-0.88 and 0.71-0.83, respectively. Intraclass correlation coefficient for OAB-V8 was 0.826 (confidence interval 95% 0.695-0.901) and it was 0.828 (confidence interval 0.623-0.922) for OAB-V3. The optimum cut-off value of OAB-V8 for detecting probable OAB was≥8 points (AUC=0.895, sensitivity 0.875, specificity 0.735), while for the OAB-V3 it was ≥ 3 (AUC=0.910, sensitivity 0.828, specificity 0.825). CONCLUSION: Both OAB-V8 and OAB-V3 scales were considered useful online self-administered screening tools, which were also feasible, reliable and valid for the detection of patients with probable OAB in the general population in Spain.

Validación psicométrica de las escalas OAB-V8 y OAB-V3 para la detección de pacientes con probable vejiga hiperactiva en la población española / Psychometric validation of the OAB-V8 and OAB-V3 scales for the screening of patients with probable overactive bladder in the Spanish population

Fundamento y objetivo: Realizar la validación psicométrica en la población española de la escala Overactive Bladder Awareness Tool (OAB-V8), y de su versión abreviada, OAB-V3, para la detección de pacientes con probable vejiga hiperactiva (VH). Pacientes y método: Estudio transversal en población general > 18 años realizado por vía telemática (Internet) sobre una población representativa de la prevalencia de VH en la población española. Las propiedades evaluadas incluyeron factibilidad, fiabilidad y validez. Los sujetos incluidos fueron clasificados según la probabilidad de VH usando un algoritmo automatizado validado previamente. Se realizó análisis de curvas ROC y se determinaron sensibilidad, especificidad, y valores predictivos positivo y negativo. Resultados: Se incluyeron 2.035 sujetos, con una edad media + DE de 52,7 + 12,1 años (50,8% varones). El 13,7% fue clasificado como «Probable»; el 27,9% como «Posible» y el 58,3% como «No» VH. La consistencia interna para las escalas OAB-V8 y OAB-V3 fue alta (0,894 y 0,851 respectivamente), con correlaciones ítem-total asimismo elevadas en ambos casos (0,87-0,88 y 0,71-0,83 respectivamente). Ambas escalas fueron fiables con coeficientes de correlación intraclase de 0,826 (intervalo de confianza del 95%: 0,695-0,901) y 0,828 (intervalo de confianza del 95%: 0,623-0,922), respectivamente. El punto de corte óptimo en la escala OAB-V8 para identificar probable VH fue ≥ 8 puntos (área bajo la curva 0,895; sensibilidad 0,875 y especificidad 0,735), mientras que en la OAB-V3 fue ≥ 3 (área bajo la curva 0,910, sensibilidad 0,828 y especificidad 0,825). Conclusión: Las escalas OAB-V8 y OAB-V3 resultaron ser herramientas útiles de cribado autoadministrado por vía telemática, factibles, fiables y válidas para la detección de pacientes con probable VH en la población general en España (AU)

Background and objective: To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB). Patients and methods: A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity. Subjects were classified according to the likelihood of OAB, using an automated algorithm validated previously. ROC curve analysis was performed, and the sensitivity, specificity, and positive and negative predictive values were also assessed. Results: A total of 2,035 subjects with a mean + SD age of 52.7 + 12.1 years were included (50.8%) men. In total 13.7% were classified as «Probable», 27.9% «Possible», and 58.3% «No» OAB. The internal consistency of both OAB-V8 and OAB-V3 scales was high (0.894 and 0.851, respectively). The item-total correlation coefficients were high; 0.87-0.88 and 0.71-0.83, respectively. Intraclass correlation coefficient for OAB-V8 was 0.826 (confidence interval 95% 0.695-0.901) and it was 0.828 (confidence interval 0.623-0.922) for OAB-V3. The optimum cut-off value of OAB-V8 for detecting probable OAB was ≥ 8 points (AUC = 0.895, sensitivity 0.875, specificity 0.735), while for the OAB-V3 it was ≥ 3 (AUC = 0.910, sensitivity 0.828, specificity 0.825). Conclusion: Both OAB-V8 and OAB-V3 scales were considered useful online self-administered screening tools, which were also feasible, reliable and valid for the detection of patients with probable OAB in the general population in Spain (AU)