[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.

The Effect of Antibiotic Prophylaxis on Post-Operative Infection in Patients Undergone Flexible Cystos-copy.

PURPOSE: The aim of this study is to determine whether antibiotic prophylaxis is required in this outpatient procedure. MATERIALS AND METHODS: A non-randomised, prospective observational study that included 184 patients subjected to flexible cystoscopy divided into three groups: - Group 1:60 patients with prophylaxis of 500 mg of ciprofloxacin;- Group 2:62 patients with prophylaxis of 3 g of phosphomycin; and Group 3:62 without antibiotic prophylaxis. Prior to inclusion in the study, absence of infection was checked by means of a urine culture obtained 7 days before the procedure. An analysis was made of urinary infection after 7 days, the cystoscopy indications and its diagnosis, the presence of comorbidities, and the urinary symptoms during the following 7 days. RESULTS: The mean age of the patients in Group 1 was 65.3 (SD: 12.5) years, 66.7 (10.8) years in Group 2, and 66.9 (10.8) years in Group 3 (P = .7). Bacteriuria was present in 15% of the patients in Group 1, compared to 22.6% in Group 2, and 12.9% in Group 3, with the differences not statistically significant. In multivariate analysis, it was observed that there was no association with the appearance of bacteriuria between the groups for age (P = .8), diabetes (P = .2), smoking (P = .4), lower urinary tract symptoms (P = .7), or immunosuppression (P = .6). CONCLUSION: The use of ciprofloxacin or phosphomycin as prophylaxis does not appear to be indicated in flexible cystoscopy in our health area.

Prospective non-randomized study on the use of antibiotic prophylaxis with ciprofloxacin in flexible urethrocystoscopy. / Estudio prospectivo no aleatorizado sobre el uso de profilaxis antibiótica en la uretrocistoscopia flexible.

OBJECTIVE: The goal of this study is to analyze whether there is a need for antibiotic prophylaxis in this outpatient procedure. METHODS: Prospective observational non-randomized study including 100 patients divided into two groups: - Group 1: 48 patients receiving 500 mg of ciprofloxacin prophylaxis 1 hour before urethrocystoscopy; - Group 2: 52 patients without antibiotic prophylaxis. Before inclusion of the patients in the study, we checked the absence of urinary tract infection by means of a urinalysis obtained 3 days before the procedure. We analyze: cystoscopy indication, cystoscopy results, presence of comorbidities, urinalysis 7 days after the procedure, and urinary symptoms within 7 days of the procedure. The statistical analysis was performed using SPSS 20.0 and the statistical significance was p=0.05. RESULTS: The average age of patients in group 1 was 66.7±12.4 versus 65.6±10.8 years in group 2 (p=0.6). There are no differences in the percentage of men/women included in the groups. 14% of patients of group 1 and 12% of group 2 presented bacteriuria, without showing any significant differences. In the multivariate study, it is observed that neither age, nor diabetes, smoking, lower urinary tract symptoms, nor immunosuppression are related with the onset of bacteriuria in the groups. CONCLUSION: We do not consider the use of ciprofloxacin as prophylaxis for flexible cystoscopy is appropriate in this area of health, since it does not reduce the presence of urinary infection or bacteriuria.

Estudio prospectivo no aleatorizado sobre el uso de profilaxis antibiótica en la uretrocistoscopia flexible / Prospective non-randomized study on the use of antibiotic prophylaxis with ciprofloxacin in flexible urethrocystoscopy

OBJETIVO: La uretrocistoscopia flexible es un procedimiento que se realiza de rutina en urología para el seguimiento de tumores vesicales y como diagnóstico en pacientes con síntomas del tracto urinario inferior y hematuria entre otra sintomatología. El objetivo de este estudio es analizar la necesidad o no de profilaxis antibiótica en este procedimiento ambulatorio. MÉTODOS: Estudio observacional prospectivo no aleatorizado en el que se incluyen 100 pacientes divididos en dos grupos: - Grupo 1: 48 pacientes con profilaxis de 500 mg de ciprofloxacino 1 h antes de la uretrocistoscopia; - Grupo 2: 52 pacientes sin profilaxis antibiótica. Previamente a la inclusión en el estudio se comprueba ausencia de infección urinaria mediante urocultivo obtenido 3 días antes del procedimiento. Se analiza indicación de cistoscopia, resultado de cistoscopia, presencia de comorbilidades, urocultivo a los 7 días, síntomas urinarios durante los 7 días siguientes. Análisis estadístico con SPSS 20.0 y significación estadística p≤0,05. RESULTADOS: La edad media de los pacientes del grupo 1 fue de 66,7±12,4 años versus 65,6±10,8 años del grupo 2 (p = 0,6). No hubo diferencias en el porcentaje de hombres/mujeres incluidos entre los grupos. El 14% de los pacientes del grupo 1 presentó bacteriuria frente al 12% del grupo 2, sin diferencias significativas. En el estudio multivariante, se observa que ni la edad, diabetes, tabaquismo, síntomas del tracto urinario inferior ni inmunosupresión se relacionan con la aparición de bacteriuria entre grupos. CONCLUSIÓN: El uso de ciprofloxacino como profilaxis en la cistoscopia flexible no lo consideramos indicado en nuestra área de salud, ya que no disminuye la presencia de infección urinaria o bacteriuria

OBJECTIVE: The goal of this study is to analyze whether there is a need for antibiotic prophylaxis in this outpatient procedure. METHODS: Prospective observational non-randomized study including 100 patients divided into two groups: - Group 1: 48 patients receiving 500 mg of ciprofloxacin prophylaxis 1 hour before urethrocystoscopy; - Group 2: 52 patients without antibiotic prophylaxis. Before inclusion of the patients in the study, we checked the absence of urinary tract infection by means of a urinalysis obtained 3 days before the procedure. We analyze: cystoscopy indication, cystoscopy results, presence of comorbidities, urinalysis 7 days after the procedure, and urinary symptoms within 7 days of the procedure. The statistical analysis was performed using SPSS 20.0 and the statistical significance was p≤0.05. RESULTS: The average age of patients in group 1 was 66.7±12.4 versus 65.6±10.8 years in group 2 (p = 0.6). There are no differences in the percentage of men/women included in the groups. 14% of patients of group 1 and 12% of group 2 presented bacteriuria, without showing any significant differences. In the multivariate study, it is observed that neither age, nor diabetes, smoking, lower urinary tract symptoms, nor immunosuppression are related with the onset of bacteriuria in the groups. CONCLUSION: We do not consider the use of ciprofloxacin as prophylaxis for flexible cystoscopy is appropriate in this area of health, since it does not reduce the presence of urinary infection or bacteriuria

Percepción del dolor en cistoscopia flexible con el uso de lidocaína intrauretral / Perception of pain in flexible cystoscopy using intraurethral lidocaine

OBJETIVO: La cistoscopia flexible es una técnica utilizada en el diagnóstico de la patología del tracto urinario inferior. El objetivo de este estudio es evaluar la eficacia del anestésico local intrauretral en la percepción del dolor en el paciente. MÉTODOS: Estudio observacional prospectivo no aleatorizado que incluye 142 hombres a los que se realiza cistoscopia flexible. Se dividen en dos grupos en función del uso o no de anestésico local intrauretral (Grupo 1: 70 hombres con anestésico intrauretral [lidocaína 2%]; Grupo 2: 72 hombres sin anestésico intrauretral). Se analiza escala visual analógica y cuestionario del dolor. Análisis estadístico con SPSS 17.0 y significación estadística p≤0,05. RESULTADOS: La edad media del grupo 1 fue de 64,7±10,3 años frente a 66,7±10,8 años en el grupo 2, sin diferencias significativas. La puntuación en la escala visual analógica en el grupo 1 fue 2,23±2,20 frente a 1,69±1,74 en el grupo 2 (p = 0,1). La intensidad del dolor total y actual en el cuestionario del dolor fue de 1,81 ± 0,87 y 1,66 ± 1,65, respectivamente, en el grupo 1 y de 1,72 ± 0,72 y 1,21±1,45, respectivamente, en el grupo 2 (no diferencias significativas). Tras dividir a los pacientes en función de una puntuación en la escala visual analógica ≤ 2, se observa que la causa que motivó la cistoscopia es un factor independiente asociado a la percepción del dolor, incrementando el riesgo de percibir más dolor en 1,89. CONCLUSIÓN: El uso de anestésico local como lubricante previo a cistoscopia flexible no parece disminuir el dolor y consideramos que no está indicado de rutina en esta técnica diagnóstica

OBJECTIVE: The aim of this study is to evaluate the efficacy of a local intraurethral anesthetic on the pain perceived by the patient during flexible cystoscopy. METHODS: An observational, prospective, nonrandomized, study was conducted on 142 males subjected to a flexible cystoscopy. The patients were divided into two groups: Group 1: 70 patients with intraurethral anesthetic (lidocaine 2%), and Group 2:72 patients without intraurethral anesthetic. The results were scored on a visual analog scale and a pain questionnaire and analyzed. The statistical analysis was performed using SPSS 17.0 and with a statistical significance of p ≤ 0.05. RESULTS: The mean age of Group 1 was 64.7 ± 10.3 years compared to 66.7 ± 10.8 years in Group 2, with no significant differences. The score on the visual analog scale in Group 1 was 2.23 ± 2.20 versus 1.69 ± 1.74 in Group 2 (p = 0.1). The overall and current pain intensity in the pain questionnaire was 1.81 ± 0.87 and 1.66 ± 1.65, respectively, in Group 1, and 1.72 ± 0.72 and 1.21 ± 1.45, respectively, in Group 2 (no significant differences). After dividing the patients into groups according to a visual analog scale score ≤ 2, it was observed that the cause that led to cystoscopy was an independent factor associated with the perception of pain, increasing the risk of perceiving more pain by 1.89. CONCLUSIÓN: The use of local anesthetic as a lubricant prior to flexible cystoscopy does not appear to reduce pain, and we consider that its routine use is not indicated

[Usefulness of antimicrobial prophylaxis with ciprofloxacin prior to flexible cystoscopy]. / ¿Está indicada la profilaxis antibiótica con ciprofloxacino en la realización de cistoscopia flexible?

BACKGROUND: Flexible cystoscopy is a common test in clinical practice done with or without antibiotic prophylaxis. AIM: To evaluate the efficacy of antibiotic prophylaxis with ciprofloxacin to reduce the incidence of urinary infection. MATERIAL AND METHODS: Prospective, non-randomized observational study that included 60 patients divided into two groups. Group 1 received prophylactic ciprofloxacin 500 mg, one hour prior to the procedure and group 2 did not receive prophylaxis. The presence of bacteriuria, symptoms or signs of urinary infection or attending Emergency rooms or primary care for these symptoms were recorded during the seven days after the cystoscopy. RESULTS: In groups 1 and 2, four and one patients had a positive urine culture, respectively. Only one patient in group 1 consulted in primary care for symptoms. No significant differences in symptoms or signs of urinary infection between groups were observed. CONCLUSIONS: In this group of patients, antibiotic prophylaxis with ciprofloxacin 500 mg prior to cystoscopy had no benefit.

¿Está indicada la profilaxis antibiótica con ciprofloxacino en la realización de cistoscopia flexible? / Usefulness of antimicrobial prophylaxis with ciprofloxacin prior to flexible cystoscopy

Background: Flexible cystoscopy is a common test in clinical practice done with or without antibiotic prophylaxis. Aim: To evaluate the efficacy of antibiotic prophylaxis with ciprofloxacin to reduce the incidence of urinary infection. Material and Methods: Prospective, non-randomized observational study that included 60 patients divided into two groups. Group 1 received prophylactic ciprofloxacin 500 mg, one hour prior to the procedure and group 2 did not receive prophylaxis. The presence of bacteriuria, symptoms or signs of urinary infection or attending Emergency rooms or primary care for these symptoms were recorded during the seven days after the cystoscopy. Results: In groups 1 and 2, four and one patients had a positive urine culture, respectively. Only one patient in group 1 consulted in primary care for symptoms. No significant differences in symptoms or signs of urinary infection between groups were observed. Conclusions: In this group of patients, antibiotic prophylaxis with ciprofloxacin 500 mg prior to cystoscopy had no benefit.

Calcium nephrolithiasis induced by topiramate.

Topiramate is an approved drug to treat seizures, but its indications have been extended to other diseases of the nervous system and as an adjuvant to chronic pain. We present four cases of topiramate-induced nephrolithiasis from 2006-2012 in women whose treatment was prescribed for pain control and as a mood stabilizer at doses of 250-300 mg/day. In two cases, the lithiasis was caused by calcium phosphate (patite) and in the other two cases by oxalate and calcium phosphate. The most common metabolic alteration was an alkaline pH, followed by hypocitraturia. The drug was discontinued in two patient; it was reduced in one and was maintained in the fourth. An increase in fluid and potassium citrate intake was prescribed. In patients starting treatment with topiramate, an adequate control and prevention of nephrolithiasis should be performed due to the risk of mixed tubular acidosis and hypocitraturia. to the risk of mixed tubular acidosis and hypocitraturia.

Nefrolitiasis cálcica inducida por topiramato / Calcium nephrolithiasis induced by topiramate

El topiramato es un fármaco aprobado para el tratamiento de crisis convulsivas, pero cuya indicación se ha extendido a otras patologías del sistema nervioso y como adyuvante del dolor crónico. En el periodo de 2006-2012 presentamos 4 casos de litiasis renal inducida por topiramato en mujeres cuyo tratamiento fue prescrito para control del dolor y como estabilizador del ánimo en dosis entre 250-300 mg/día. En dos casos la litiasis fue de fosfato cálcico (apatita) y otros dos casos de litiasis de oxalato y fosfato cálcico. La alteración metabólica más frecuente fue pH urinario alcalino seguido de hipocitraturia. Se retiró el fármaco en 2 pacientes, en 1 se redujo la dosis y en otro se mantuvo. Se indicó aumento de ingesta hídrica y citrato potásico. En pacientes que inician tratamiento con topiramato debe realizarse un control y profilaxis adecuada de litiasis renal por riesgo de acidosis tubular mixta e hipocitraturia

Topiramate is an approved drug to treat seizures, but its indications have been extended to other diseases of the nervous system and as an adjuvant to chronic pain. We present four cases of topiramate-induced nephrolithiasis from 2006-2012 in women whose treatment was prescribed for pain control and as a mood stabilizer at doses of 250-300 mg/day. In two cases, the lithiasis was caused by calcium phosphate (apatite) and in the other two cases by oxalate and calcium phosphate. The most common metabolic alteration was an alkaline pH, followed by hypocitraturia. The drug was discontinued in two patients; it was reduced in one and was maintained in the fourth. An increase in fluid and potassium citrate intake was prescribed. In patients starting treatment with topiramate, an adequate control and prevention of nephrolithiasis should be performed due to the risk of mixed tubular acidosis and hypocitraturia