Recent studies showed that the non-adherence to the pharmacological therapy of patients affected by BPH-associated LUTS increased the risk of clinical progression of BPH. We examined the patients adherence to pharmacological therapy and its clinical consequences in men with BPH-associated LUTS looking at the differences between drug classes comparing mono vs combination therapy. A retrospective, population-based cohort study, using prescription administrative database and hospital discharge codes from a total of 1.5 million Italian men. Patients ≥40 years, administered alpha-blockers (AB) and 5alpha-reductase inhibitors (5ARIs), alone or in combination (CT), for BPH-associated LUTS were analyzed. The 1–year and long term adherence together with the analyses of hospitalization rates for BPH and BPH-related surgery were examined using multivariable Cox proportional hazards regression model and Pearson chi square test. Patients exposed to at least 6 months of therapy had a 1-year overall adherence of 29 % (monotherapy AB 35 %, monotherapy 5ARI 18 %, CT 9 %). Patient adherence progressively declined to 15 %, 8 % and 3 % for AB, 5ARI, and CT, respectively at the fifth year of follow up. Patients on CT had a higher discontinuation rate along all the follow-up compared to those under monotherapy with ABs or 5ARIs (all p < 0.0001). Moreover, CT was associated with a reduced risk of hospitalization for BPH-related surgery (HR 0.94; p < 0.0001) compared to AB monotherapy. Adherence to pharmacological therapy of BPH-associated LUTS is low and varies depending on drugs class. Patients under CT have a higher likelihood of discontinuing treatment for a number of reasons that should be better investigated. Our study suggests that new strategies aiming to increase patient’s adherence to the prescribed treatment are necessary in order to prevent BPH progression.

Background: Oral pharmacotherapies to treat overactive bladder (OAB) are used less in men despite a similar prevalence of storage symptoms as women. The efficacy and safety of once-daily mirabegron 50 mg was evaluated in male OAB patients from five phase III studies that included placebo or antimuscarinic (tolterodine ER 4 mg or solifenacin 5 mg) as a comparator. Methods: Three pooled 12-week placebo-controlled studies (mirabegron 50 mg versus placebo) and one 12-week non-inferiority phase IIIb study (BEYOND; mirabegron 50 mg versus solifenacin 5 mg) were used for efficacy (daily micturition frequency, urgency and incontinence episodes) and safety analyses. An additional 52-week active-controlled phase III safety study (mirabegron 50 mg versus tolterodine ER 4 mg) was included in the safety analysis. Male patients aged ⩾18 years with OAB for ⩾3 months were included in the analyses. Patients may also have a history of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)/benign prostatic enlargement (BPE) or concomitant use of α₁-blockers. Results: In the pooled studies, mirabegron 50 mg demonstrated superiority versus placebo (treatment difference: −0.37 [95% confidence interval (CI): −0.74, −0.01]) for reducing micturition frequency; improvements in urgency and incontinence were not significantly different between mirabegron 50 mg and placebo. In BEYOND, mirabegron 50 mg was comparable with solifenacin 5 mg for reducing micturition frequency, urgency, and incontinence episodes. Mirabegron was well tolerated at 12 and 52 weeks and overall treatment-emergent adverse events (AEs) were similar to those with placebo. Conclusions: In a male OAB population with or without LUTS associated with BPH/BPE, mirabegron 50 mg provided similar improvements in urgency, frequency, and incontinence as solifenacin 5 mg, and is a well-tolerated alternative to antimuscarinics. In the three pooled 12-week studies, significant differences were not seen for urgency and incontinence versus placebo, although mirabegron 50 mg did demonstrate significant improvements versus placebo for frequency.

Prostate cancer (PC) is a frequent male malignancy and represents the second most diagnosed cancer in men. Since pre-cancerous lesions, i.e., the high-grade prostatic intraepithelial neoplasia (HGPIN), can be detected years before progression to PC, early diagnosis and chemoprevention are targeted strategies to reduce PC rates. Animal studies have shown that lycopene, a carotenoid contained in tomatoes, is a promising candidate for the chemoprevention of PC. However, its efficacy in humans remains controversial. The present study aimed to investigate the relevance of plasma and prostate concentration of lycopene after a lycopene-enriched diet in patients diagnosed with HGPIN. Thirty-two patients diagnosed with HGPIN were administered a lycopene-enriched diet (20–25 mg/day of lycopene; through 30 g/day of triple concentrated tomato paste) for 6 months. A 6-month follow-up prostate biopsy assessed progression to PC. Patients were classified into three groups according to the histopathological features of the 6-month follow-up biopsy results: prostatitis; HGPIN and PC. PSA and plasma lycopene levels were measured before and after the dietary lycopene supplementation. Prostatic lycopene concentration was only assessed after the supplementation diet. Only prostatic lycopene concentration showed significant differences between the three groups (p = 0.03). Prostatic lycopene concentration below a 1 ng/mg threshold was associated with PC at 6-month follow-up biopsy (p = 0.003). We observed no overall benefits from a 6-month lycopene supplementation, as the rate of HGPIN progression to PC in our population (9/32, 28%) was similar to rates reported in the literature. Baseline PSA levels also showed no significant changes after a lycopene-enriched diet. Our findings point to prostatic lycopene concentration as a promising biomarker of PC. Further prospective longitudinal studies are needed to assess the prognostic role of prostatic lycopene in PC.

In last years Metabolic Syndrome (MetS) has been closely associated to Benign Prostatic Enlargement (BPE) Aim of our study is to evaluate the effect of MetS and each single MetS parameter on prostate growth in men surgically treated for BPE. Overall, 379 men were prospectively enrolled in two tertiary referral centers. Calculated prostate volume (PV) was measured with transrectal US defining the antero-posterior (AP), the cranio-caudal (CC) and the latero-lateral (LL) diameters through the ellipsoid formula, while raw PV was calculated by suprapubic US. MetS was defined according to the NCEP-ATPIII criteria. One-hundred and forty men (36.9%) were affected by MetS. The number of MetS parameters (0 to 5) and the presence of MetS were correlated with the calculated PV. The number of MetS parameters were also directly related to increasing prostate diameters. At the binary logistic regression, MetS resulted associated to high (>60 cc) raw and calculated PV. Moreover, multivariate analysis suggested that AP diameter was mainly correlated with HDL cholesterol (r:-0.3103, p = 0.002) CC diameter with triglycerides (r:-0.191, p = 0.050) and LL diameter with systolic blood pressure (r:0.154, p = 0.044). However, at the binary logistic regression, only low HDL Cholesterol was the main determinant for the enlargement of all diameters and consequently of the whole PV. Metabolic factors, specially dyslipidemia, could play a central role in the pathogenesis and progression of BPE/LUTS. Interventional studies are needed to evaluate the impact of early treatment of dyslipidemia on progression of LUTS/BPH.

Even though evidence based medicine, guidelines and algorithms still represent the pillars of the management of chronic diseases (i.e: hypertension, diabetes mellitus), a patient centred approach has been recently proposed as a successful strategy, in particular to improve drug adherence. Aim of the present review is to evaluate the unmet needs in LUTS/BPH management and the possible impact of a patient centered approach in this setting. A National Center for Biotechnology Information (NCBI) PubMed search for relevant articles published from January 2000 until December 2016 was performed by combining the following MESH terms: patients centred medicine, patient centered care, person centered care, patient centered outcomes, value based care, shared decision making, male, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, treatment. We followed the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). All studies reporting on patient centred approach, shared decision making and evidence-based medicine were included in the review. All original article, reviews, letters, congress abstracts, and editorials comments were included in the review. Studies reporting single case reports, experimental studies on animal models and studies not in English were not included in the review. Overall 751 abstracts were reviewed, out of them 87 full texts were analysed resulting in 36 papers included. The evidence summarised in this systematic review confirmed how a patient centred visit may improve patient’s adherence to medication. Although a patient centred model has been rarely used in urology, management of Low Urinary Tract Symptoms (LUTS) and Benign Prostatic Obstruction (BPO) may represent the perfect ground to experiment and improve this approach. Notwithstanding all the innovations in LUTS/BPO medical treatment, the real life picture is far from ideal. Recent evidence shows a dramatical low drug adherence and satisfaction to medical treatment in LUTS/BPH patients. A patient centred approach may improve drug adherence and some unmet needs in this area, potentially reducing complications and costs. However further well designed studies are needed to confirm this data.