Combining mirabegron 25/50 mg and solifenacin 5/10 mg improves objective and subjective efficacy outcomes compared with placebo or solifenacin 5 mg.

Study Type – Therapy (RCT)
Level of Evidence 1b OBJECTIVES To evaluate the efficacy and safety of the phosphodiesterase type 5 inhibitor UK‐369,003 for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in men with and without erectile dysfunction (ED). PATIENTS AND METHODS This was a multicentre, double‐blind, placebo‐ and active‐controlled, parallel‐group study conducted across 45 centres in North and South America, Europe, and Australia. In all, 418 men aged ≥40 years with a clinical diagnosis of BPH, an International Prostate Symptom Score (IPSS) of ≥13, and maximum urinary flow rate (Qmax) of 5–15 mL/s for a voided volume of >150 mL were stratified into two groups (with and without ED) and randomized to one of seven treatment groups, i.e. UK‐369,003 at 10, 25, 50 or 100 mg modified release (MR), UK‐369,003 40 mg immediate release (IR), tamsulosin 0.4 mg prolonged release, or placebo, for 12 weeks. The primary study endpoint was the change in total IPSS after 12 weeks of treatment. Secondary efficacy measures were IPSS storage and voiding subscores, Qmax, International Index of Erectile Function–Erectile Function domain, questions 5 and 6 of the Quality of Erection Questionnaire, the International Consultation on Incontinence Questionnaire–Male LUTS, the patient‐reported treatment‐impact questionnaire, and a bladder diary in which patients recorded the number of voluntary urinary voids, volume of urine voided per micturition, leaks, and urgency episodes. RESULTS The mean change in the IPSS from baseline at week 12 for UK‐369,003 100 mg MR and 40 mg IR was −2.91 and −2.50 better than placebo, respectively. There was increasing efficacy with increasing dose of the MR formulation. For UK‐369,003 100 mg MR, Qmax improved by 2.10 mL/s compared with 0.84 mL/s in the placebo group. CONCLUSIONS UK‐369,003 had clinically meaningful efficacy and was well tolerated in men with LUTS associated with BPH. The Bayesian statistical analysis gave high posterior probabilities for true differences between UK‐369,003 100 mg MR and placebo. There was greater preference, satisfaction and willingness to use UK‐369,003 again for all treatment groups compared with placebo.

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Purpose: Authors analyzed their experience with urinary bladder tumours. This article discusses clinical and histopathological diagnostics and treatment procedures, and follow up of patients with rare benign urinary bladder tumours. Methods: 406 patients with bladder tumours were treated in our department between January 2000 and December 2008. 322 patients had superfi cial tumours and 84 had primary invasive tumours. All patients who underwent transurethral resections of these tumours were operated under general or spinal anaesthesia. The resected specimens were histologically examined in the department of Pathology. Results: 399 of the 406 patients had urothelial bladder cancer, 7 patients had a histologically uncommon type of bladder tumour, one female was diagnosed with sarcomatoid bladder cancer, one patient had a histologically confi rmed feochromocytoma of the urinary bladder. Two males had epidermoid carcinoma. One female had a histologically described uncommon benign pseudoneoplastic lesion, chararacteristic for endosalpingiosis. Another two patients were diagnosed with infl ammatory myofi broblastic tumour of the urinary bladder. Both patients presented with gross macroscopic haematuria. Authors performed complete transurethral tumour resections, which required several sessions and the deliberation of a blocked ureter through nephrostomy in one case. Conclusion: More than 98 % of all treated patients had urothelial bladder cancer in different stages and grades. Two patients had rare benign infl ammatory proliferation of the bladder wall which formed large tumorous bleeding masses obstructing the ureter in one case. These types of bladder tumour could be treated conservatively with meticulous long term follow up similarly to patients with bladder cancer (Tab. 1, Fig. 4, Ref. 15).

Objectives To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer. Patients and methodsIn this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336. Results Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/ dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported. Conclusions LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.