[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.

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) / 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)

OBJETIVO: Evaluar la efectividad y latolerabilidad del tratamiento con Pygeum africanum (P.africanum) en pacientes con síntomas del tracto urinario inferior (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 secundarios incluyeron 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 compararon con 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.

OBJECTIVES: To assess the effectiveness and 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 observational study 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, satisfaction and 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 significant impairment 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 significant improvement (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 during 6 months improved significantly QoL and LUTS inpatients with BPH, with a high level of satisfaction

Efficacy and Safety of Mirabegron Add-on Therapy to Solifenacin in Incontinent Overactive Bladder Patients with an Inadequate Response to Initial 4-Week Solifenacin Monotherapy: A Randomised Double-blind Multicentre Phase 3B Study (BESIDE).

BACKGROUND: Incontinence has a greater detrimental effect on quality of life than other symptoms of overactive bladder (OAB) and is often difficult to treat with antimuscarinic monotherapy. OBJECTIVE: To evaluate the efficacy and the safety and tolerability of combination (solifenacin 5mg and mirabegron 50mg) versus solifenacin 5 or 10mg in OAB patients remaining incontinent after 4 wk of solifenacin 5mg. DESIGN, SETTING, AND PARTICIPANTS: OAB patients remaining incontinent despite daily solifenacin 5mg during 4-wk single-blind run-in were randomised 1:1:1 to double-blind daily combination or solifenacin 5 or 10mg for 12 wk. Patients receiving the combination were initiated on mirabegron 25mg increasing to 50mg after week 4. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was a change from baseline to end of treatment (EOT) in the mean number of incontinence episodes per 24h (stratified rank analysis of covariance [ANCOVA]). Key secondary end points were a change from baseline to EOT in the mean number of micturitions per 24h (ANCOVA) and number of incontinence episodes noted in a 3-d diary at EOT (mixed-effects Poisson regression). A trial (BESIDE) comparing combination treatment (solifenacin plus mirabegron) with one treatment alone (solifenacin) tested the superiority of combination versus solifenacin 5mg, noninferiority (and potential superiority) of combination versus solifenacin 10mg (key secondary end points), and the safety and tolerability of combination therapy versus solifenacin monotherapy. RESULTS AND LIMITATIONS: A total of 2174 patients were randomised to combination (n=727), solifenacin 5mg (n=728), or solifenacin 10mg (n=719). At EOT, combination was superior to solifenacin 5mg, with significant improvements in daily incontinence (p=0.001), daily micturitions (p<0.001), and incontinence noted in a 3-d diary (p=0.014). Combination was noninferior to solifenacin 10mg for key secondary end points and superior to solifenacin 10mg for improving daily micturitions. All treatments were well tolerated. CONCLUSIONS: Adding mirabegron 50mg to solifenacin 5mg further improved OAB symptoms versus solifenacin 5 or 10mg, and it was well tolerated in OAB patients remaining incontinent after initial solifenacin 5mg. PATIENT SUMMARY: In this 12-wk study, overactive bladder patients who remained incontinent despite initial solifenacin 5mg treatment received additional treatment with mirabegron 50mg. Combining mirabegron 50mg with solifenacin 5mg was superior to solifenacin 5mg alone in improving symptoms of incontinence and frequent urination, and it was well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov NCT01908829.

The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial.

OBJECTIVE: To compare the efficacy and safety of mirabegron 50 mg and solifenacin 5 mg in overactive bladder (OAB) patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy. PATIENTS AND METHODS: This randomized, double-blind, phase IIIb, noninferiority study, enrolled male and female patients aged ⩾18 years old, with symptoms of OAB for ⩾3 months, who were dissatisfied with their previous antimuscarinic drug due to lack of efficacy. A total of 1887 patients were randomized to receive mirabegron 50 mg (n = 943) or solifenacin 5 mg (n = 944) daily for 12 weeks. The primary efficacy endpoint was change from baseline to end of treatment in mean number of micturitions/24 h. Noninferiority was confirmed if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference between solifenacin and mirabegron was > -0.20. Secondary efficacy endpoints, which included change from baseline in mean number of incontinence episodes/24 h, urgency incontinence episodes/24 h, urgency episodes (grade 3 or 4)/24 h and nocturia episodes/24 h, were analyzed using analysis of covariance. RESULTS: For the primary endpoint, adjusted mean treatment difference (95% CI) in mean number of micturitions/24 h was -0.18 (-0.42, 0.06) and therefore noninferiority of mirabegron to solifenacin was not demonstrated. Both treatments demonstrated clinically meaningful reductions in efficacy variables and were well tolerated, with a lower incidence of dry mouth with mirabegron. CONCLUSIONS: Noninferiority of mirabegron compared with solifenacin for reduction in micturition frequency could not be demonstrated in this population of OAB patients who were dissatisfied with previous antimuscarinic therapy due to lack of efficacy. Both mirabegron and solifenacin improved key OAB symptoms with no statistically significant differences observed between the two treatments. Both drugs were well tolerated.

Efficacy of mirabegron in patients with and without prior antimuscarinic therapy for overactive bladder: a post hoc analysis of a randomized European-Australian Phase 3 trial.

BACKGROUND: Antimuscarinic agents are currently the predominant treatment option for the clinical management of the symptoms of overactive bladder (OAB). However, low rates of persistence with these agents highlight the need for novel, effective and better-tolerated oral pharmacological agents. Mirabegron is a ß3-adrenoceptor agonist developed for the treatment of OAB, with a mechanism of action distinct from that of antimuscarinics. In a randomized, double-blind, placebo- and active-controlled Phase 3 trial conducted in Europe and Australia (NCT00689104), mirabegron 50 mg and 100 mg resulted in statistically significant reductions from baseline to final visit, compared with placebo, in the co-primary end points - mean number of incontinence episodes/24 h and mean number of micturitions/24 h. We conducted a post hoc, subgroup analysis of this study in order to evaluate the efficacy of mirabegron in treatment-naïve patients and patients who had discontinued prior antimuscarinic therapy because of insufficient efficacy or poor tolerability. METHODS: Patients were randomized to placebo, mirabegron 50 or 100 mg, or tolterodine extended release (ER) 4 mg orally, once-daily, for 12 weeks. For the post hoc analysis, the primary patient population was divided into the following subgroups: (1) patients who had not received any prior antimuscarinic OAB medication (treatment-naïve) and (2) patients who had received prior antimuscarinic OAB medication. The latter subgroup was further subdivided into patients who discontinued due to: (3) insufficient efficacy or (4) poor tolerability. Analysis of the co-primary efficacy endpoints by subgroup was performed using analysis of covariance with treatment group, subgroup, sex, geographical region, and subgroup-by-treatment interaction as fixed factors; and baseline value as a covariate. RESULTS: Mirabegron, 50 mg and 100 mg once-daily, demonstrated similar improvements in the frequency of incontinence episodes and micturitions in OAB patients who were antimuscarinic-naïve and who had discontinued prior antimuscarinic therapy. While mirabegron demonstrated improvements in incontinence and micturition frequency in patients who had discontinued prior antimuscarinic therapy due to insufficient efficacy, the response to tolterodine was similar to that of placebo. CONCLUSION: In this post hoc subgroup analysis, mirabegron provided treatment benefits in OAB patients who were antimuscarinic treatment-naïve and in patients who had received prior antimuscarinic treatment.

Efficacy and tolerability of mirabegron, a ß(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial.

BACKGROUND: Mirabegron, a ß(3)-adrenoceptor agonist, has been developed for the treatment of overactive bladder (OAB). OBJECTIVE: To assess the efficacy and tolerability of mirabegron versus placebo. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomised double-blind, parallel-group placebo- and tolterodine-controlled phase 3 trial conducted in 27 countries in Europe and Australia in patients ≥ 18 yr of age with symptoms of OAB for ≥ 3 mo. INTERVENTION: After a 2-wk single-blind placebo run-in period, patients were randomised to receive placebo, mirabegron 50mg, mirabegron 100mg, or tolterodine extended release 4 mg orally once daily for 12 wk. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients completed a micturition diary and quality-of-life (QoL) assessments. Co-primary efficacy end points were change from baseline to final visit in the mean number of incontinence episodes and micturitions per 24h. The primary comparison was between mirabegron and placebo with a secondary comparison between tolterodine and placebo. Safety parameters included adverse events (AEs), laboratory assessments, vital signs, electrocardiograms, and postvoid residual volume. RESULTS AND LIMITATIONS: A total of 1978 patients were randomised and received the study drug. Mirabegron 50-mg and 100-mg groups demonstrated statistically significant improvements (adjusted mean change from baseline [95% confidence intervals]) at the final visit in the number of incontinence episodes per 24h (-1.57 [-1.79 to -1.35] and -1.46 [-1.68 to -1.23], respectively, vs placebo -1.17 [-1.39 to -0.95]) and number of micturitions per 24h (-1.93 [-2.15 to -1.72] and -1.77 [-1.99 to -1.56], respectively, vs placebo -1.34 [-1.55 to -1.12]; p<0.05 for all comparisons). Statistically significant improvements were also observed in other key efficacy end points and QoL outcomes. The incidence of treatment-emergent AEs was similar across treatment groups. The main limitation of this study was the short (12-wk) duration of treatment. CONCLUSIONS: Mirabegron represents a new class of treatment for OAB with proven efficacy and good tolerability. TRIAL IDENTIFICATION: This study is registered at ClinicalTrials.gov, identifier NCT00689104.

Radiologic findings of segmental testicular infarction.

OBJECTIVE: Our objective was to describe the radiologic findings of segmental testicular infarction and to establish a proper diagnosis that can avoid orchiectomy. CONCLUSION: The presence of a triangular-shaped avascular intratesticular lesion on sonography or MRI and enhancement of the surrounding borders on enhanced MR images may suggest a presurgical diagnosis of segmental testicular infarction and therefore avoid a total orchiectomy in these patients.