[Effectiveness of treatment with Pygeum africanum in patients with lower urinary tract symptoms and benign prostatic hyperplasia: a cross-sectional study in the real-world clinical practice in Spain (The PROFIT Study)]. / Efectividad del tratamiento con Pygeum africanum en pacientes con síntomas del tracto urinario inferior e hiperplasia benigna de próstata: estudio transversal en la práctica clínica real en España (Estudio PROFIT).

OBJECTIVES: To assess the effectivenessand tolerability of treatment with P africanum(P. africanum) in patients with lower urinary tractsymptoms (LUTS) associated with benign prostatichyperplasia (BPH) in routine clinical practice. MATERIAL AND METHODS: Cross-sectional observationalstudy in which 115 patients with LUTS/BPHtreated for 6 months with P. africanum (Tebetane® compuesto)in real-world clinical practice conditions wereincluded. The primary objective was to assess thequality of life (QoL) according to changes in the scoresof item 8 of the International Prostate Symptom Score(IPSS) questionnaire (a score ≥ 4 indicates a significantimpairment of QoL). Secondary objectives includedimprovement of urinary symptoms, urinary flow, satisfactionand compliance with treatment as well astolerability. Data were collected in a single scheduledvisit at 6 months of treatment with P. africanum andwere compared with data registered in the medicalrecords at the beginning of treatment. RESULTS: After 6 months of treatment withP. africanum, the percentage of patient with significantimpairment of QoL was 22.6% as compared with45.2% at the initiation of treatment (P 0,-001). Theoverall IPSS score showed a mean decreas of -4,-5points (median -4,0, interquartile range [IQR] -7,-0 to-2,0) and 69 patients (60%) showed a clinically significantimprovement (reduction of ≥ 4 points). Therewere significant decreases in IPSS subscales of storage(mean -1,-8; median -2,-0, IQR -3,-0 to 0 (P 0,-001)and voiding (mean -1,-9; median -2,-0, IQR -3,-0 to 0)(P 0,-001) symptoms. The degree of satisfaction and compliance with treatment was high with mean scores(median) of 6,9 (7,0) and 9,2 (10), respectively in the1-10 visual analogue scale. Treatment-related adverseeffects did not occur. CONCLUSIONS: Treatment with P. africanum during6 months improved significantly QoL and LUTS inpatients with BPH, with a high level of satisfaction andcompliance with treatment, without adverse events.

OBJETIVO: Evaluar la efectividad y latolerabilidad del tratamiento con Pygeum africanum (P.africanum) en pacientes con síntomas del tracto urinarioinferior (STUI) asociados a hiperplasia benigna depróstata (HBP) en la práctica clínica habitual.MATERIAL Y MÉTODOS: Estudio observacionaltransversal en el que se incluyeron 115 pacientes conSTUI/HBP tratados durante 6 meses con P. africanum (Tebetane® compuesto) en condiciones de prácticaclínica real. El objetivo primario fue evaluar la calidadde vida (CdV) en función del cambio en la pregunta 8del cuestionario de Puntuación Internacional de losSíntomas Prostáticos (IPSS) (puntuación ≥ 4 indicaafectación significativa de la CdV). Los objetivos secundariosincluyeron la mejoría de síntomas urinarios,flujo urinario, satisfacción y cumplimiento con eltratamiento, así como la tolerabilidad del mismo. Losdatos se recogieron en una única visita programada alos 6 meses de tratamiento con P. africanum y se compararoncon los registrados en la historia clínica alinicio del tratamiento. RESULTADOS: Tras 6 meses de tratamiento conP. africanum, el porcentaje de pacientes con afectaciónsignificativa de la CdV fue del 22,6% en comparacióncon un 45,2% al inicio del tratamiento (P 0,001).La puntuación global del IPSS disminuyó de mediaen -4,5 puntos (mediana -4,0, rango intercuartílico [RIQ] -7,0 a -2,0) y 69 pacientes (60%) mostraron unamejoría clínicamente significativa (disminución ≥ 4puntos). Se observaron disminuciones significativasen las subescalas del IPSS de los síntomas de llenado(media -1,8; mediana -2,0, RIQ -3,0 a 0) (P 0,001) yvaciado (media -1,9; mediana -2,0, RIQ -3,0 a 0) (P 0,001). El grado de satisfacción y cumplimiento con eltratamiento fue elevado con valores medios (mediana)de 6,9 (7,0) y 9,2 (10) respectivamente, en una escalaanalógica visual 1-10 cm. No se registraron efectosadversos relacionados con el tratamiento. CONCLUSION: El tratamiento con P. africanum(P. africanum) durante 6 meses mejoró significativamentela CdV y los STUI en pacientes con HBP, con unalto grado de satisfacción y cumplimiento con el tratamiento,sin registrarse reacciones adversas.

Cysticlean® a highly pac standardized content in the prevention of recurrent urinary tract infections: an observational, prospective cohort study.

BACKGROUND: The present study was aimed at determining the prophylactic efficacy of American cranberry (AC) extract (Cysticlean®) in women with recurrent symptomatic postcoital urinary tract infections (PCUTI), non-consumer of AC extract in the past 3 months before inclusion, and to determine changes in their quality of life (QoL). METHODS: This was a single center, observational, prospective study in a total of 20 women (mean age 35.2 years; 50.0% were married). Patients were followed up for 3 and 6 months during treatment. RESULTS: The number of PCUTIs in the previous 3 months prior to start the treatment with Cysticlean® was 2.8±1.3 and it was reduced to 0.2±0.5 at Month 6 (P<0.0001), which represent a 93% improvement. At baseline, the mean score on the VAS scale (range from 0 to 100) for assessing the QoL was 62.4±19.1, increasing to 78.2±12.4 at Month 6 (P=0.0002), which represents a 20% improvement. All patients had an infection with positive urine culture at baseline, after 6 months there were only 3 symptomatic infections (P<0.001). The most common bacterium was Escherichia coli. CONCLUSIONS: Prophylaxis with American cranberry extract (Cysticlean®) could be an alternative to classical therapies with antibiotics. Further studies are needed to confirm results obtained in this pilot study.

[Green light laser efficacy in patients with prostatic hyperplasia treatment with 5-alpha reductase inhibitors]. / Eficacia de la fotovaporización prostática con láser verde en el tratamiento de la hiperplasia prostática en pacientes en tratamiento con inhibidores de la 5-alfa-reductasa.

INTRODUCTION: High prevalence of BPH and gradual ageing of the population, combined with the existence of effective medical treatments for this condition, has led to an increasing use of surgery in patients on long-term treatment with 5-alpha reductase inhibitors (5-ARIs). Initially, patients treated with 5-ARIs were not considered good candidates for photoselective vaporization of the prostate with green laser. OBJECTIVE: To assess, using a retrospective study based on our experience, wheter long-term treatment (longer than 6 months) with 5-alpha reductase inhibitors decreases effectiveness of photoselective vaporization of the prostate with green light laser in BPH. MATERIALS AND METHODS: From September 2005 to January 2008, 102 patients underwent photoselective vaporization of the prostate with green light laser. Of these, 25 patients (24.5%) had been treated with 5-ARIs for at least 6 months, and the remaining 77 patients (75.5%) were used as controls. A retrospective study was conducted to compare the pre- and postoperative clinical and functional parameters of patients with and without prior 5-RAI therapy. RESULTS: No statistically significant differences were found between the treated and control groups in preoperative prostatic volume (50 mL vs 49 mL), IPSS (17.6 vs 17.8), postvoiding residue (16% vs 18%), or PSA (1.4 ng/mL vs 2.2 ng/mL). Similarly, while differences were seen in energy spread (180 kJ vs 175 kJ for the treated and control groups respectively) and operating time (63 min vs 57 min), these were not statistically significant. No between-group differences were found either in clinical or flow rate parameters one month after surgery (IPSS 13.8 vs 14 and Qmax 13.9 mL/s vs 14.5 nL/s in the treated and control groups respectively). Surgeons reported a better visualization of the endoscopic field that was attributed to less bleeding during the procedure. CONCLUSIONS: Our results show no statistically significant differences in peroperative and preoperative parameters between patients with and without treatment with 5-alpha reductase inhibitors. We therefore think that photoselective vaporization of the prostate with green light laser is a safe and effective technique in patients treated with 5-ARIs.

Eficacia de la fotovaporización prostática con láser verde en el tratamiento de la hiperplasia prostática en pacientes en tratamiento con inhibidores de la 5-alfa-reductasa / Green light laser efficacy in patients with prostatic hyperplasia treatment with 5-alpha reductase inhibitors

Introducción: El progresivo envejecimiento de la población y la elevada prevalencia de la hiperplasia benigna prostática (HBP), unidos a la existencia de tratamientos médicos efectivos para esta afección, produce que cada vez más indiquemos la cirugía en pacientes tratados a largo plazo con inhibidores de la 5-alfa-reductasa (5ARI). En un principio, los pacientes tratados con 5ARI no se consideraban buenos candidatos para la fotovaporización prostática con láser verde. Objetivo: En el siguiente trabajo, mediante un estudio retrospectivo basado en nuestra experiencia, pretendemos dilucidar si el tratamiento a largo plazo (mas de 6 meses) con inhibidores de la 5ARI reduce la eficacia del tratamiento con láser verde en pacientes afectados de HBP. Material y métodos: Entre septiembre de 2005 y enero de 2008 hemos tratado a 102 pacientes mediante fotovaporización prostática con láser verde, de los que 25 (24,5%) se encontraban en tratamiento con 5ARI durante al menos 6 meses; los otros 77 (75,5%) pacientes formaron el grupo control. Realizamos un estudio retrospectivo en el que comparamos los parámetros clínicos y funcionales pre y postoperatorios de los pacientes tratados con 5ARI respecto a los que no lo estaban. Resultados: No encontramos diferencias estadísticamente significativas en cuanto a volumen prostático (50 cc y 49 cc), IPSS (17,6 y 17,8), residuo posmiccional (16% y 18%) o antígeno prostático específico (PSA) (1,4 ng/ml y 2,2 ng/ml) preoperatorios entre los grupos tratamiento y control, respectivamente. Del mismo modo, si bien existieron diferenciasen cuanto a la energía usada (180 kJ y 175 kJ) y el tiempo quirúrgico empleado (63 min y 57 min), ambas fueron más elevadas en el grupo tratado con 5ARI, estas diferencias no resultaron significativas estadísticamente. Tampoco encontramos diferencias en los parámetros clínicos (IPSS 13,8 y 14 al primer mes) ni flujométricos (Qmáx 13,9 ml/s y 14,5ml/s en la revisión al primer mes) entre pacientes tratados y no tratados. Subjetivamente, se apreció una mejor visualización del campo endoscópico atribuida a un menor sangrado durante la intervención. Conclusiones: Nuestros resultados no demuestran diferencias estadísticamente significativas entre pacientes con y sin tratamiento con inhibidores de la 5ARI en cuanto a parámetros intra y preoperatorios, por lo que pensamos que este tratamiento no disminuye la eficacia de la fotovaporización prostática con láser verde (AU)

Introduction: High prevalence of BPH and gradual ageing of the population, combined with the existence of effective medical treatments for this condition, has led to an increasing use of surgery in patients on long-term treatment with 5-alpha reductase inhibitors (5-ARIs). Initially, patients treated with 5-ARIs were not considered good candidates for photoselective vaporization of the prostate with green laser. Objective: To assess, using a retrospective study based on our experience, wheter long-term treatment (longer than 6 months) with 5-alpha reductase inhibitors decreases effectiveness of photoselective vaporization of the prostate with green light laser in BPH. Materials and methods: From September 2005 to January 2008, 102 patients underwent photoselective vaporization of the prostate with green light laser. Of these, 25 patients (24.5%) had been treated with 5-ARIs for at least 6 months, and the remaining 77 patients (75.5%) were used as controls. A retrospective study was conducted to compare the pre and postoperative clinical and functional parameters of patients with and without prior 5-RAI therapy. Results: No statistically significant differences were found between the treated and control groups in preoperative prostatic volume (50 mL vs 49 mL), IPSS (17.6 vs 17.8), postvoiding residue (16% vs 18%), or PSA (1.4 ng/mL vs 2.2 ng/mL). Similarly, while differences were seen in energy spread (180 kJ vs 175 kJ for the treated and control groups respectively) and operating time (63 min vs 57 min), these were not statistically significant. No between group differences were found either in clinical or flow rate parameters one month after surgery (IPSS 13.8 vs 14 and Qmax 13.9mL/s vs 14.5 nL/s in the treated and control groups respectively). Surgeons reported a better visualization of the endoscopic field that was attributed to less bleeding during the procedure. Conclusions: Our results show no statistically significant differences in peroperative and preoperative parameters between patients with and without treatment with 5-alphareductase inhibitors. We therefore think that photoselective vaporization of the prostate with green light laser is a safe and effective technique in patients treated with 5-ARIs (AU)