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Objective: To evaluate the effectiveness of poloxamer‐based thermo‐sensitive sol–gel instillation, after transurethral resection of the prostate (TURP), for preventing urethral stricture. Patients and Methods: In all, 198 patients underwent TURP for benign prostatic hyperplasia. Recruited patients were randomly divided into two groups: groups A and B. Patients in Group A (100 patients, experimental group) received poloxamer‐based thermo‐sensitive sol–gel instillation and patients in the Group B (98 patients, control group) received lubricant instillation after TURP. Each patient was evaluated at 4 (V1), 12 (V2), and 24 weeks (V3) after TURP. The effectiveness of poloxamer‐based thermo‐sensitive sol–gel instillation was evaluated based on the International Prostate Symptom Score (IPSS), IPSS‐Quality of Life (QoL), Overactive bladder questionnaire (OAB‐q), maximum urinary flow rate (Qmax), post‐void residual urine volume (PVR), and cystoscopy. Results: Amongst the initial 198 participants, 80 patients in Group A and 83 in Group B completed the study. There were no significant differences in IPSS‐QoL and OAB‐q between the groups. However, Qmax was significantly different between groups A and B, at a mean (SD) of 18.92 (9.98) vs 15.58 (9.24) mL/s (P = 0.028) at 24 weeks after TURP. On cystoscopic examination, urethral stricture after TURP was found in two of the 80 patients in Group A and 10 of 83 in Group B (P = 0.023). Conclusions: Poloxamer‐based thermo‐sensitive sol–gel instillation after TURP lowered the incidence of urethral stricture. [ABSTRACT FROM AUTHOR]

Objective: To verify the efficacy and safety of tamsulosin 0.4 mg and tamsulosin 0.2 mg compared with those of placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).Methods: A total of 494 patients from multiple centers participated in this double-blind, randomized, phase 3 trial. Eligible patients were randomly assigned to the tamsulosin 0.4 mg group, tamsulosin 0.2 mg group or placebo group. The International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual (PVR) urine volume, blood pressure, heart rate and adverse events were compared among the three groups at 4, 8 and 12 weeks.Results: A total of 494 BPH patients were analyzed. There were no differences in the baseline characteristics among the three groups. After 12 weeks of treatment, total IPSS was improved in the 0.2 mg and 0.4 mg tamsulosin groups; however, the extent of improvement was greater in the 0.4 mg group than in the 0.2 mg group (0.4 mg: -9.59 vs. 0.2 mg: -5.61; least-squares mean difference [95% confidence interval]: -3.95 [-5.01, -2.89], p < .0001). In addition, in the patients with severe symptoms (IPSS ≥20), total IPSS was improved the most in the 0.4 mg group (-11.27 ± 5.00, p < .0001). Qmax and PVR were improved in the 0.4 mg and 0.2 mg groups; however, the differences were not statistically significant between treatment groups. No patients experienced any serious adverse effects in any of the three groups.Conclusions: Tamsulosin 0.4 mg and 0.2 mg appear to be superior to placebo treatment, and tamsulosin 0.4 mg is more effective than 0.2 mg in terms of total IPSS improvement. Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH. ClinicalTrials.gov Identifier: NCT02390882. [ABSTRACT FROM AUTHOR]

Objectives We aimed to examine the treatment patterns, and patient-reported outcomes ( PROs) in benign prostatic hyperplasia ( BPH) patients with overactive bladder ( OAB) symptoms. Methods Seven hundred and forty seven patients were included in this prospective observational study. The primary endpoint was to describe the medical treatment patterns for BPH patients with OAB symptoms. The secondary endpoint was to determine the PROs of these patients. Clinical outcome was assessed using International prostate symptom score ( IPSS), and PROs were measured using BPH-Related QoL Questionnaire Korea 1 ( BPH QoL K1) and Euroqol-5 Dimension ( EQ-5D). Results When starting the study, 391 patients (52.3%) received α-blocker monotherapy, whereas 356 (47.7%) received combination therapy with anticholinergics. Of the 369 patients who completed the 6-month treatment, 139 patients (37.7%) still received α-blocker monotherapy, 122 (33.1%) still received combination therapy with anticholinergics, and 108 (29.3%) received subsequent anticholinergics in addition to α-blocker. When the patients were stratified, storage subscore was higher (9.5 vs. 8.8, P = 0.034) and voiding subscore (9.7 vs. 11.6, P = 0.001) was lower in patients with anticholinergics than those without it. Although all treatment groups reported a significant improvement from baseline, no significant between-group differences in changes in IPSS, EQ-5D and BPH QoL K1 was found. Conclusions About one-third of patients received α-blocker monotherapy, one-third received combination therapy with anticholinergics, and another one-third received subsequent anticholinergics in addition to α-blocker. Storage subscore was higher in patients with anticholinergics than those without it, but vice-versa for voiding subscore. Similar improvement on clinical outcomes and PROs was observed in all treatment groups. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the clinical characteristics of patients with maximal urine flow rate ( Qmax) ≥ 25 ml/s complaining of lower urinary tract symptoms (LUTS), using propensity score-matching analysis to compare with the control group. Methods: Medical records from a prospectively maintained database for first visit male patients with LUTS/benign prostatic hyperplasia between 2010 and 2012 were used to select 818 patients. Of these patients, 68 men with Qmax ≥ 25 ml/s were defined as the supervoider group, and 68 patients were selected for the control group using propensity scores, which were calculated for each patient using multivariable logistic regression model based on the following covariates: age, prostate volume, voided urine volume, and post-voided residual volume. International Prostate Symptom Score (IPSS), quality of life score, and Overactive Bladder Symptom Score (OABSS) were also analyzed. Results: Mean Qmax was 30.82 ± 5.13 in supervoiders and 15.95 ± 4.88 ml/s in controls ( p < 0.001). There were statistical differences in IPSS between supervoiders and controls (12.63 ± 5.81 vs. 16.13 ± 6.90; p = 0.002). Although the IPSS voiding symptom sub-score in supervoiders was lower than controls (5.09 ± 3.35 vs. 7.40 ± 4.00; p < 0.001), there were no significant differences in storage symptom and post-micturitional symptom sub-scores. In OABSS and subdomain scores for frequency, nocturia, and urgency, there were no significant differences between the groups. However, the urge incontinence subdomain score was significantly higher in supervoiders versus controls (0.69 ± 1.26 vs. 0.18 ± 0.52; p = 0.003). Conclusions: Supervoiders experience comparable levels of storage and post-micturition symptoms, but display more severe urge incontinence despite milder voiding symptoms and better uroflowmetric measurements than propensity score-matched controls. [ABSTRACT FROM AUTHOR]

Background Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Aims To assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED. Methods A randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED. Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg (FDC 0.4/5 mg), tamsulosin 0.2 mg plus tadalafil 5 mg (FDC 0.2/5 mg), or tadalafil 5 mg for a 12-week treatment period. For a subsequent 12-week extension period, the patients were administered FDC 0.4/5 mg. Outcomes The primary outcomes were changes from baseline in total International Prostate Symptom Score (IPSS) and International Index of Erectile Function erectile function domain (IIEF-EF) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg. The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24. Results The mean changes in total IPSS and IIEF-EF scores were −9.46 and 9.17 for FDC 0.4/5 mg and −8.14 and 9.49 for tadalafil 5 mg, respectively, which indicated superiority in LUTS improvement ( P = .0320) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg. However, the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement. No clinically significant adverse events regarding the investigational products were observed during the 24-week period. Clinical Implications The FDC 0.4/5 mg is the first combined formulation of an α-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED. Strengths and Limitations The study clearly demonstrated the advantage of FDC 0.4/5 mg. The main advantage of FDC 0.4/5 mg was the enhanced efficacy on BPH-associated LUTS comorbidity with ED, the lower incidence of side effects, and the simplification and convenience of therapy, which led to better overall patient compliance. However, the lack of a tamsulosin monotherapy control group was a limitation of this study. Conclusion The FDC 0.4/5 mg therapy was safe, well tolerated, and efficacious, indicating that combination therapy could provide clinical benefits for patients with BPH-associated LUTS complaints and ameliorate the comorbidity of ED. Kim SW, Park NC, Lee SW, et al. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial. J Sex Med 2017;14:1018–1027. [ABSTRACT FROM AUTHOR]