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Introduction: Correction of benign prostatic hyperplasia (BPH) with lower urinary tract (LUT) symptoms (LUTS) is treated with drugs of different pharmacological classes having side effects including suppression of sexual function., Aim: To assess the effect of simultaneous intake of dutasteride and solifenacin on the reversibility of severe LUTS and sexual function in men with BPH., Methods: Patients from group A took dutasteride 0.5 mg/d, those from group В took dutasteride 0.5 mg/d and solifenacin 10 mg/d, and those from group С took dutasteride 0.5 mg/d and solifenacin 20 mg/d. The duration of the observation was 6 months. The sexual function was rated with the International Index of Erectile Function questionnaire and Men's Sexual Health Questionnaire-ejaculatory dysfunction. The functional status of LUT was rated with International Prostate Symptom Score, overactive bladder questionnaire-awareness tool, diary voiding, and uroflowmetry., Main Outcome Measure: The state of sexual function and function of the LUT in men improved., Results: The erectile function in all men, having participated in the study, did not change [group A, 9.8 (1.6)/9.4 (3.8), P ≥ .05; group B, 10.1 (2.1)/10.5 (3.7), P ≥ .05; group C, 9.7 (1.5)/9.5 (2.6), P ≥ .05]. The ejaculator function significantly decreased in all groups. According to International Prostate Symptom Score, obstruction diminished in this group [incomplete emptying, 3.7 (0.7)/1.5 (0.3), P ≤ .05; intermittence, 3.5 (1.0)/3.5 (1.0), P ≤ .05; weak stream, 3.8 (0.6)/1.5 (0.4), P ≤ .05; straining, 3.4 (0.5)/0.7 (0.7), P ≤ .05] as did hyperactivity [urgency, 2.8 (0.7)/0.9 (0.7), P ≤ .05; nocturia, 2.8 (0.6)/1.2 (0.4), P ≤ .05]. All numbers in the manuscript are given in points unless otherwise stated. The values in parentheses are SD (unless otherwise specified)., Clinical Implications: The information that a high dose of solifenacin administered concomitantly with dutasteride may contribute to increase in sexual satisfaction and preservation of erectile function at the baseline level can be useful and used by sexologists, urologists, and family doctors., Strength & Limitations: The combination of dutasteride 0.5 mg/d and solifenacin 10 mg/d saves erectile function and improves sexual satisfaction. At the same time, the symptoms of obstruction and hyperactivity disappear or are reduced in most patients. Nevertheless, we did not study late results of the combined therapy., Conclusion: Suggested combination does not impact on erectile function but decreases ejaculator function; however, it does not affect a general high rating of sexual function by patients. Thus, overall sexual function in men with BPH and severe LUTS is not impaired by prolonged intake of double dosage of solifenacin combined with dutasteride. The combination of dutasteride and solifenacin is effective and safe to treat BPH and severe LUTS. Kosilov K, Kuzina I, Kuznetsov V, et al. The Risk of Sexual Dysfunction and Effectiveness of Treatment of Benign Prostatic Hyperplasia With Severe Lower Urinary Tract Dysfunction With Combination of Dutasteride and Solifenacin. J Sex Med 2018;15:1579-1590., (Copyright © 2018 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: The emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs., Materials and Methods: In NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months., Results: Across both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%-1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%-1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/UR events occurred within 4 months of treatment initiation., Conclusions: FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS., Competing Interests: This study was supported by Astellas Pharma Europe. Marcus J. Drake reports non-financial support from Astellas, during the conduct of the study. Outside the submitted work, he reports grants, personal fees, and non-financial support from Allergan, personal fees from Apogepha, grants and personal fees from Ferring, grants and personal fees from Pfizer, and grants, personal fees, and non-financial support from Astellas. Matthias Oelke reports non-financial support from Astellas, during the conduct of the study, and has received lecturer and/or consultant honoraria from Apogepha, Astellas, Bayer, GlaxoSmithKline, Eli Lilly and Company, Ferring, Mundipharma, Pfizer, and Recordati, and has received research grants from Astellas. Dominique Bongaerts, Monique Klaver, Robert Snijder, Klaudia Traudtner, and Karin van Charldorp are employees of Astellas Pharma Europe B.V. Philip van Kerrebroeck reports non-financial support from Astellas, during the conduct of the study, and reports personal fees from Allergan, Astellas, and Ferring, and grants from Medtronic, outside the submitted work. Following this clinical trial program, the FDC tablet of Soli 6 mg + TOCAS 0.4 mg has been registered in 42 countries (Vesomni™ or Urizia™). There are no patents or products in development to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Objective: The objective of this study was to evaluate the safety and efficacy of tamsulosin hydrochloride 0.2 mg (TAM) and its combination with solifenacin succinate 5 mg (SOL) after transurethral resection of the prostate (TURP)., Patients and Methods: The patients were randomized into three groups: TURP (group 1), TURP plus TAM (group 2), and TURP plus TAM + SOL (group 3). Patients in group 2 and group 3 received medication for 4 weeks. The primary efficacy end points were the mean change in total International Prostate Symptom Score (IPSS) and IPSS subscores. The secondary end points included quality-of-life score, Overactive Bladder Symptom Score, and short-form voiding and storage score of International Continence Society., Results: In total, 37 men (31.8%) in group 1, 37 men (31.8%) in group 2, and 42 men (36.2%) in group 3 completed the study. In total IPSS, no significant improvement was seen from baseline to the end of treatment in groups 2 and 3 compared with group 1. However, in group 2, the decrement in the IPSS storage score was smaller than group 1 ( P =0.02), and in group 3, the decrement in the IPSS voiding score was smaller than group 1 ( P =0.05). In groups 2 and 3 compared with group 1, improvements in the quality of life score, total score of Overactive Bladder Symptom Score, and short-form voiding score and storage score of International Continence Society were not statistically significant., Conclusion: Treatment with TAM and combination of TAM and SOL did not have significant additional benefits for lower urinary tract symptoms during the early recovery period after TURP.

Background: Short-term trials have demonstrated the efficacy and safety of combination therapy using antimuscarinics and α-blockers in men with lower urinary tract symptoms (LUTS). The Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS (oral controlled absorption system) in Males with Lower Urinary Tract Symptoms (NEPTUNE) II is the first long-term study using solifenacin (Soli) and the oral controlled absorption system formulation of tamsulosin (TOCAS)., Objective: To evaluate long-term (up to 52 wk) safety and efficacy of flexible dosing of two fixed-dose combinations (FDC) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms., Design, Setting, and Participants: Patients with both storage and voiding LUTS, maximum urinary flow rate of 4.0-12.0 ml/s, prostate size <75 ml, and postvoid residuals ≤ 150 ml, who completed the 12-wk, double-blind NEPTUNE study could continue in the 40-wk, open-label NEPTUNE II study., Intervention: FDC of Soli 6 mg plus TOCAS 0.4 mg, or Soli 9 mg plus TOCAS 0.4mg; patients could switch between doses in NEPTUNE II., Outcome Measurements and Statistical Analysis: Safety and efficacy data from NEPTUNE and NEPTUNE II were combined to cover a 52-wk period. Primary efficacy end points were total International Prostate Symptom Score (IPSS) and total urgency and frequency score (TUFS); secondary end points included IPSS storage and voiding subscores, micturition diary variables, and quality of life parameters., Results: In all, 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II. Treatment-emergent adverse events were reported in 499 (46.8%) patients who participated in NEPTUNE II; most were mild or moderate. Urinary retention occurred in 13 of 1208 (1.1%) patients receiving one or more FDCs in NEPTUNE and/or NEPTUNE II; 8 (0.7%) required catheterisation (acute urinary retention [AUR]). Reductions in total IPSS and TUFS during NEPTUNE were maintained for up to 52 wk of FDC treatment, with mean reductions of 9.0 (standard deviation [SD]: 5.7) and 10.1 (SD: 9.2), respectively, from baseline to end of treatment. Clinically relevant improvements were also observed for secondary efficacy end points., Conclusions: Long-term treatment with FDC Soli plus TOCAS was well tolerated and efficacious in men with storage and voiding LUTS, with a low incidence of AUR., Patient Summary: Treatment with solifenacin plus tamsulosin in a fixed-dose combination tablet was well tolerated by men with lower urinary tract symptoms. Improvements in symptoms were achieved after 4 wk of treatment, with further improvements at week 16 maintained for up to 52 wk throughout the study., (Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To evaluate the efficacy and safety of tamsulosin and solifenacin combination therapy compared with tamsulosin monotherapy for male lower urinary tract symptoms (LUTS)., Methods: We identified all eligible studies that compared tamsulosin and solifenacin combination therapy with tamsulosin monotherapy for male LUTS (up to January 2015). The fixed- or random-effects model was selected depending on the proportion of heterogeneity., Results: Seven articles were identified as eligible for this meta-analysis, with a total of 3063 participants. Synthetic data showed combination therapy had significant improvements in Storage International Prostate Symptom Score (WMD = -0.60; 95% CI: -0.81 to -0.38, P < 0.0001), quality of life (WMD = -0.23; 95% CI: -0.34 to -0.11, P < 0.0001), micturitions per 24 hours (WMD = -0.70; 95% CI: -0.86 to -0.55, P < 0.0001) and urgency episodes per 24 hours (WMD = -0.26; 95% CI: -0.48 to -0.05, P = 0.018). The incidence of adverse effects in the tamsulosin and solifenacin combined therapy group (30.82%) was similar to the tamsulosin monotherapy group (25.75%). Acute urinary retention was seldom reported in the studies and no clinically significant changes regarding Qmax were showed in our meta-analysis., Conclusions: Tamsulosin and solifenacin combination therapy may be a reasonable option for male LUTS patients, especially for those who have significant storage symptoms. However, PVR should be measured during treatment to assess the increase in PVR or the incidence of AUR.

We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system (TOCAS) with placebo or TOCAS monotherapy. The aim of the meta-analysis was to clarify the efficacy and safety of the combination treatments method for lower urinary tract symptoms (LUTS). We searched for trials of men with LUTS that were randomized to combination treatment compared with TOCAS monotherapy or placebo. We pooled data from three placebo-controlled trials meeting inclusion criteria. Primary outcomes of interest included changes in International Prostate Symptom Score (IPSS) and urinary frequency. We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention (UR), adverse events. Data were pooled using random or fixed effect models for continuous outcomes and the Mantel-Haenszel method to generate risk ratio. Reductions in IPSS storage subscore and total urgency and frequency score (TUFS) were observed with solifenacin 6 mg plus TOCAS compared with placebo (P< 0.0001 and P< 0.0001, respectively). Reductions in IPSS storage subscore and TUFS were observed with solifenacin 9 mg plus TOCAS compared with placebo (P = 0.003 and P= 0.0006, respectively). Reductions in TUFS was observed with solifenacin 6 mg plus TOCAS compared with TOCAS (P = 0.01). Both combination treatments were well tolerated, with low incidence of UR. Solifenacin 6 mg plus TOCAS significantly improved total IPSS, storage and voiding symptoms compared with placebo. Solifenacin 6 mg plus TOCAS also improved storage symptoms compared with TOCAS alone. There was no additional benefit of solifenacin 9 mg compared with 6 mg when used in combination with TOCAS.