Solifenacin 6mg / Tamsulosin 400microgram modified-release tablets

BackgroundPatients with benign prostatic hyperplasia (BPH) receive α-blockers as first-line therapy to treat lower urinary tract symptoms; however, some individuals still experience residual storage symptoms. Antimuscarinics, β3-agonists, and desmopressin are effective add-on medications. Nevertheless, there is currently no evidence for the appropriate choice of the first add-on medication. This systematic review aimed to investigate the clinical benefits of antimuscarinics, β3-agonists, and desmopressin, in addition to α-blockers, for persistent storage symptoms in BPH patients.MethodsA comprehensive literature search of randomized controlled trials (RCTs) comparing the efficacy of different add-on medications in BPH patients with persistent storage symptoms despite α-blocker treatment was conducted. Clinical outcomes included the International Prostate Symptom Score (IPSS), IPSS storage subscore, nocturia, micturition, and urgency. A network meta-analysis was performed to estimate the effect size. Surface under cumulative ranking curves (SUCRAs) were used to rank the included treatments for each outcome.ResultsA total of 15 RCTs were identified. Add-on imidafenacin and mirabegron resulted in significant improvement in all outcomes assessed. Other add-on medications such as desmopressin, tolterodine, solifenacin, fesoterodine, and propiverine showed positive benefits for most, but not all, outcomes. Based on the SUCRA rankings, add-on desmopressin was the best-ranked treatment for IPSS and nocturia, and add-on imidafenacin was the best for the IPSS storage subscore and micturition.ConclusionsBPH patients presenting with persistent storage symptoms despite α-blocker administration are recommended to include additional treatment. Desmopressin and imidafenacin may be considered high-priority add-on treatments because of their superior efficacy compared with other medications.

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BackgroundUreteral stent insertion, crucial for managing ureteral obstructions, often results in stent-related symptoms (SRSs) adversely affecting patient quality of life. This meta-analysis compares the effectiveness of tamsulosin or mirabegron versus placebo in alleviating these symptoms.MethodsFollowing PRISMA guidelines, we systematically reviewed randomized controlled trials (RCTs) comparing mirabegron or tamsulosin to placebo in managing SRSs. Data sources included PubMed, Embase, Web of Science and CENTRAL, up to November 2023. The inclusion criteria focused on studies reporting on Ureteral Stent Symptom Questionnaire (USSQ), International Prostate Symptom Score (IPSS), quality of life (QoL) assessments, analgesic usage and adverse events. Meta-analysis employed a random-effects model, assessing heterogeneity and publication bias. For assessing the risk of bias in the included randomized trials, we employed the Cochrane Collaboration's tool. This protocol was registered at the International Prospective Register of Systematic Reviews (registration number: CRD42024511842).ResultsSixteen RCTs with 1635 patients met the inclusion criteria. Tamsulosin significantly improved body pain (MD -1.80; 95% CI -3.53 to -0.07; p = 0.04), sexual function (MD -0.63; 95% CI -1.16 to -0.10; p = 0.02) and improved quality of life score (MD -2.36; 95% CI -3.56 to -1.17; p = 0.0001), while mirabegron was more effective in reducing urinary symptoms (MD -8.71; 95% CI -15.81 to -1.61; p = 0.02), enhancing general health (MD -2.58; 95% CI -3.78 to -1.37; p p = 0.008). Both medications significantly reduced total International Prostate Symptom Score (Tamsulosin MD -8.4; 95% CI -15.63 to -1.22; p = 0.02; Mirabegron MD -6.29; 95% CI -8.50 to -4.08; p p = 0.42 and OR 0.93; 95% CI 0.30-2.88; p = 0.89).ConclusionsTamsulosin and mirabegron effectively manage SRSs, with distinct benefits in different symptom domains. This suggests a potential for complementary therapeutic strategies. Future high-quality RCTs are needed to explore their combined efficacy.

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BackgroundLower urinary tract symptoms (LUTS) are common in men and can lead to impaired quality of life. While phosphodiesterase type 5 inhibitors (PDE5-Is) are established in managing LUTS related to benign prostatic hyperplasia (BPH), their role in non-BPH male LUTS remains unclear. This systematic review aimed to evaluate the efficacy and safety of PDE5-Is in men with LUTS unrelated to prostate enlargement.MethodsA systematic search of four databases (PubMed, Web of Science, ScienceDirect, and EBSCO) identified five eligible clinical trials that enrolled men with LUTS secondary to non-BPH etiologies such as post-prostate brachytherapy, overactive bladder (OAB), and double-J (DJ) ureteral stents. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB-2) tool for randomized trials and the Risk of Bias in Non-randomized Studies of Intervention (ROBINS-I) tool for non-randomized trials. Data were synthesized descriptively due to heterogeneity and limited number of studies. Our review was registered in advance in PROSPERO (CRD420251072896).ResultsFrom 341 identified studies, 5 clinical trials met the inclusion criteria. Interventions included tadalafil, sildenafil, and combination regimens with tamsulosin or solifenacin. PDE5-Is consistently improved urinary symptoms, International Prostate Symptom Score (IPSS) reduction, pain, storage and voiding scores, and sexual function. Tadalafil showed the most consistent benefits, particularly in sexual health and pain relief, while combination therapy (tamsulosin + solifenacin or sildenafil) yielded broader urinary symptom improvement. Objective measures such as the maximum urinary flow rate (Qmax) and post-void residual (PVR) improved modestly but less consistently. This review is limited by the small number of studies and the heterogeneity of participants among the included studies.ConclusionsPDE5-Is, especially tadalafil, are effective and well-tolerated for non-BPH LUTS in men, offering advantages beyond urinary symptom relief, including sexual function preservation and pain reduction. These potential effects should be further explored, particularly when erectile dysfunction (ED) or discomfort is present.

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PURPOSE: Doxazosin and tamsulosin are the most frequently used α1-blockers for the treatment of male lower urinary tract symptoms. Clinical practice guidelines state that all α1-blockers have a similar clinical efficacy but differ in tolerability when used in appropriate doses. We compared the efficacy and tolerability of different doses/formulations of doxazosin (immediate release 2, 4 or 8mg; gastrointestinal therapeutic system [GITS] 4 or 8mg) versus tamsulosin (modified release 0.2, 0.4 or 0.8mg; oral controlled absorption system [OCAS] 0.4mg). METHODS: PubMed, EMBASE and Cochrane databases were systematically searched until December 2024 to identify RCTs with doxazosin and/or tamsulosin. Bayesian random-effects models estimated efficacy and tolerability outcomes, including all International Prostate Symptom Score (IPSS) variations, QoL, overall adverse events (AE) and discontinuation. Tests for heterogeneity, similarity, and consistency ensured robust estimates. RESULTS: In total, 1,866 abstracts were identified, of which we included 40 publications with 12,201 participants. Doxazosin GITS 4mg had the largest mean (95% credible interval) improvement from baseline in total IPSS (-10.07 [-11.96, -8.25]), IPSS-QoL (-1.82 [-2.07, -1.60]) and IPSS storage-subscore (-4.26 [-4.29, -3.40]), and was statistically superior compared to most tamsulosin doses. No significant differences between different doses or formulations for the two drugs were seen for the IPSS voiding-subscore, maximum urine flow or post-void residuals. Only doxazosin GITS 4mg had significantly lower odds of discontinuation due to AE compared to tamsulosin OCAS 0.4mg. CONCLUSIONS: This network meta-analysis found a statistically significantly greater clinical efficacy (IPSS-T, IPSS-S, QoL improvement) for doxazosin GITS 4mg versus most tamsulosin formulations and a similar overall tolerability profile.

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BackgroundWe conducted a meta-analysis to assess the efficacy and safety of mirabegron on overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving tamsulosin therapy.MethodsWe performed the analysis by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The databases including MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were retrieved to get information regarding randomized controlled trials of mirabegron on OAB induced by BPH in men receiving tamsulosin therapy. We also searched the references of included literatures.ResultsThree randomized controlled trials containing a total of 1317 BPH patients were included in the analysis. Co-primary efficacy end points: the mean number of micturitions per day [the mean difference (MD) = -0.27, 95% confidence interval (CI): -0.46 to -0.09, P = .004], the urgency episodes per day (the MD = -0.50, 95% CI: -0.77 to -0.22, P = .0004), the total OAB symptom score (the MD = -0.69, 95% CI: -1.00 to -0.38, P ConclusionsThis analysis demonstrates that mirabegron is an effective and safe treatment for OAB symptoms induced by BPH in men receiving tamsulosin therapy with a low occurrence of side effects. Besides, we should be aware that the administration of mirabegron might have the risk of increasing post-void residual urine volume.

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Beta-3 adrenoceptor (B3AR) agonist which mediate detrusor relaxation has been tried as a new treatment modality for men with benign prostatic hyperplasia (BPH). However, it remains unclear whether the B3AR agonist has more clinical benefits and fewer adverse effects in men with BPH than in women. We performed a comprehensive search using multiple databases, trials registries, other sources of grey literature, and conference proceedings regardless of language or publication status and included randomized controlled trials. Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. Primary outcomes were urologic symptom scores, quality of life (QoL), and overall adverse events. We found 4 randomized controlled trials with 1,105 participants in 3 comparisons. All studies reported short-term outcomes (ranged from 8 weeks to 12 weeks). Mirabegron, tamsulosin, silodosin, fesoterodine, and tadalafil were administrated as intervention. While B3AR agonist can improve the patient-important outcomes within group (before and after treatment), B3AR agonist combination therapy with current standard BPH treatment such as alpha blocker or anticholinergic may not have additional effects on urological symptom scores and QoL compared to alpha blocker or anticholinergic monotherapy. B3AR agonist therapy with phosphodiesterase 5 inhibitor (PDE5I) showed statistical improvement on urological symptom scores or QoL compared to PDE5I monotherapy. For safety profile, B3AR agonist in all 3 comparisons may not increase adverse event rate. While B3AR agonists may be used for the treatment of lower urinary tract symptoms in men with BPH if storage symptoms with standard BPH treatment are insufficient, B3AR agonists appear to have trivial or similar effects compared to current standard BPH treatment.

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