Solifenacin 6mg / Tamsulosin 400microgram modified-release tablets

Background: Although ureteral stents are a well-established and commonly used method for renal drainage, the ureteral stent-related symptoms (SRSs) they cause in patients cannot be ignored. It is currently unclear whether mirabegron has a place in the treatment of SRSs. Our study aims to systematically evaluate the efficacy and safety of mirabegron in treating SRSs in adult patients. Methods: Through a systematical search of multiple scientific databases before August 2023, we performed a systematic review and meta-analysis of the primary outcomes of interest according to the PRISMA. Analysis was performed under multivariate random-effects network models and effects of drugs was ranked with surface under the cumulative ranking curves (SUCRA) probabilities. Results: Sixteen studies involving 2,002 patients were included. All regimens (including mirabegron, solifenacin, and tamsulosin) were significantly better than placebo in urinary symptoms. Solifenacin was associated with more adverse drug events than mirabegron and tamsulosin. The SUCRA values showed that mirabegron was the best in the outcomes of body pain (71.5%), sexual matters (76.4%), and adverse events (70.5%). Solifenacin was the best in the outcomes of urinary symptoms (73.1%), general health (81.0%), and work performance (85.1%). Tamsulosin had the lowest rate of all outcomes. Conclusions: Compared with traditional drugs for relieving SRSs, mirabegron performs best in terms of alleviating body pain, sexual matters, and adverse events, with little difference in urinary symptoms and general health. Further high-quality prospective double-blinded randomized controlled trials (RCTs) are required to provide sufficient evidence supporting our observations.

Abstract licence: CC BY-NC-ND

Ureteral stents, commonly used in urology, can cause side effects affecting patient quality of life. However, studies on managing lower urinary tract symptoms showed inconsistencies due to the use of various alpha-blockers and antimuscarinic drugs. The aim of this study was to evaluate the effectiveness of combining tamsulosin and solifenacin therapy compared to tamsulosin and solifenacin monotherapy for treating stent-related symptoms. Randomized controlled trials assessing tamsulosin, solifenacin, or their combination for stent-related symptoms treatment were identified through a comprehensive search of four databases (PubMed, Scopus, Web of Science, and Cochrane) from January 2018 to December 2023. Ureteral stent symptom questionnaire (USSQ), international prostate symptom score (IPSS), visual analog scale (VAS), and quality of life (QoL) were pooled for meta-analysis. Eleven studies with a total of 1,627 patients were included in the quantitative analysis. Solifenacin significantly improved urinary symptoms (MD: 15.31; 95%CI: 0.36–30.26; p=0.040) and reduced the IPSS (MD: -2.52; 95%CI: -3.68–-1.36; p<0.00001) compared to the control group. Tamsulosin reduced urinary symptoms on the USSQ (MD: 14.27; 95%CI: 8.68–19.86; p<0.00001), general health problems (MD: 4.53; 95%CI: 2.13­–6.94; p=0.0002), and IPSS (MD: -0.95; 95%CI: -1.86–-0.03; p<0.00001) compared to the control group. Solifenacin demonstrated a more significant reduction in the overall IPSS compared to tamsulosin (MD: -1.57; 95%CI: -2.85–-0.29; p=0.020). The combination of solifenacin and tamsulosin resulted in a significantly superior reduction in IPSS compared to solifenacin monotherapies (MD: -2.30; 95%CI: -3.23–-1.37; p<0.00001) and tamsulosin monotherapy (MD -3.17; 95%CI: -5.07­–-1.27; p=0.00001). No significant differences were found between tamsulosin and solifenacin in terms of QoL (MD: 0.12; 95%CI: -0.01–0.26; p=0.070) and VAS (MD: 0.25; 95%CI: -0.95–1.44; p=0.690). In conclusion, solifenacin was more effective than tamsulosin in reducing stent-related symptoms, and the combination of tamsulosin and solifenacin was superior to either monotherapy in alleviating stent-related symptoms.

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Abstract Background Ureteral 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. Methods Following 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). Results Sixteen 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 < 0.0001) and reducing analgesia use (MD −1.56; 95% CI −2.70 to −0.41; 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 < 0.00001) without a significant rise in adverse events (tamsulosin OR 1.90; 95% CI 0.40–9.18; mirabegron p = 0.42 and OR 0.93; 95% CI 0.30–2.88; p = 0.89). Conclusions Tamsulosin 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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This study is aimed to systematically evaluate the efficacy of tamsulosin combined with solifenacin and provide clinical evidence for treatment of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS). PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang data information service platform were searched to select randomized controlled trials (RCTs) of tamsulosin combined with solifenacin in the treatment of BPH with LUTS. After extraction of the data, the statistical information was calculated by means of STATA 12.0. The publication bias was calculated using Egger's test and Begg's funnel plot. A total of 17 articles contained 1,870 patients treated with tamsulosin in combination with solifenacin and 1,897 patients treated with tamsulosin only were included in this study. Results show that tamsulosin combined with solifenacin therapy was more effective in reducing the Total International Prostate Symptom Score (TIPSS), Storage International Prostate Symptom Score (SIPSS), Quality of life (QOL), and Overactive bladder symptom score (OABSS) in comparison with tamsulosin monotherapy treatment. However, it was found that the combination therapy may increase levels of prostate-specific antigen (PSA) and the maximal urinary flow rate (QMAX). Differences between the combination therapy and tamsulosin monotherapy were not statistically significant for urgency episodes per 24 h, micturitions per 24 h, Voiding International Prostate Symptom Score (VIPSS), and postvoid residual volume (PVR). Tamsulosin combined with solifenacin therapy is more effective than tamsulosin monotherapy for the treatment of BPH concurrent with LUTS and won't increase the risk of dysuria.

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Introduction: The application of double-J ureteral stents in urology is widespread, but their use is often accompanied by complications and bothersome symptoms, affecting patients’ quality of life (QoL). While various medications have been tested for alleviating the symptoms associated with double-J stents, consensus on their effectiveness remains elusive. This study aims to investigate the effectiveness of tamsulosin, solifenacin, mirabegron, desloratadine, and combination therapy using a Romanian-adapted version of the Ureteral Stent Symptom Questionnaire (USSQ). Materials and Methods: A prospective, observational, randomised trial was conducted at the Urology and Renal Transplant Clinic of Dr. “C.I. Parhon” Clinical Hospital in Iasi between 1 January 2022 and 1 August 2023. Three hundred twenty seven patients who underwent their first double-J stent insertion were evaluated with the Romanian-adapted USSQ at baseline and 30 days post-insertion. Patients were randomly divided into six groups based on the prescribed medications: control, tamsulosin, mirabegron, solifenacin, desloratadine, and combination therapy. Results: The data suggest a significant reduction in symptoms in patients who received medication compared with the control group. Furthermore, the combined medication of solifenacin 10 mg and tamsulosin 0.4 mg was particularly effective in reducing pain with statistical significance compared to the control group (p = 0.001). The highest mean scores for urinary symptom severity were observed in the control group (12.37 ± 6.82), and the lowest was in the mirabegron group (9.94 ± 5.82). The individuals who received a daily dose of 50 mg of mirabegron saw the most notable influence on their job. Conclusions: While no single medication emerged as a “miracle drug” for managing symptoms related to double-J stent insertion, the combination therapy of solifenacin and tamsulosin is the most promising option for improving symptoms related to double-J stent insertion and QoL. Additional extensive research is required to validate these initial results.

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Treatment of male lower urinary tract symptoms (LUTS) has traditionally focused on the management of benign prostatic obstruction, but the contribution of bladder dysfunction has been recently recognized. Therefore, it is well understood that LUTS have multifactorial etiology and often occur in clusters and not in isolation. Voiding LUTS are highly prevalent in men, but storage LUTS have been proved to be more bothersome. α1-Blockers are the most widely used pharmacologic agents for the treatment of symptoms relating to benign prostatic enlargement due to benign prostatic hyperplasia (BPH), while antimuscarinics are the drug class of choice for overactive bladder symptoms. A combination of the two drug classes would be a reasonable approach to treat men with both storage and voiding symptoms, and several short-term studies have proved the efficacy and safety of different combinations with an α1-blocker and an antimuscarinic. Following previous studies on the separate administration of solifenacin and tamsulosin, a fixed-dose combination tablet of tamsulosin oral controlled absorption system (OCAS) 0.4 mg and solifenacin succinate 6 mg has been recently introduced, and the current review evaluates the available data on the use of this fixed-dose combination in the treatment of LUTS in men with BPH.

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BACKGROUND: Benign prostatic hyperplasia (BPH) is a common urological condition in aging men that causes lower urinary tract symptoms. Pharmacotherapy is central to BPH management; however, considering updated guidelines, recent prescription trends remain insufficiently explored. This study aimed to assess initial pharmacotherapy trends in patients newly diagnosed with BPH. METHODS: This cross-sectional analysis used 2015-2020 data from the Health Insurance Review and Assessment Service to examine the trends and influencing factors of BPH drug utilization among South Korean patients aged ≥ 40 years with no prior history of BPH. Subgroup analyses were performed by categorizing patients into five age groups (40-49, 50-59, 60-69, 70-79, and ≥ 80 years) to evaluate age-specific prescription patterns. RESULTS: Of the 1,445,144 patients newly diagnosed with BPH, 1,336,695 (92.4%) initiated treatment within 60 days of diagnosis. Among those treated, 54.9% received α-blocker (AB) monotherapy and 17.9% received 5α-reductase inhibitor (5-ARI)/AB combinations. Use of 5-ARI/AB combinations increased with age, from 8.0% in patients in their 40s to 25.4% in those aged ≥ 80 years. Tamsulosin (a selective AB), dutasteride (a 5-ARI), and mirabegron (a β3-agonist) were the most frequently prescribed agents. CONCLUSION: Recent American Urological Association (AUA) guidelines recommend combination therapy as an effective strategy for reducing the risk of BPH-related complications. Although the largest proportion of patients was prescribed AB monotherapy, the growing adoption of combination therapy in South Korea, particularly among older age groups, suggests a shift toward more guideline-concordant and effective therapeutic approaches.

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Background Urinary retention (UR) is a clinical condition where patients cannot fully empty their bladder. Although numerous drugs are associated with UR, comprehensive and reliable studies identifying drugs that induce UR are scarce. Methods This study leveraged data from the FDA Adverse Event Reporting System (FAERS) and the Canadian Vigilance Adverse Reaction (CVAR) database to explore adverse events (AEs) related to UR from 2004 to Q1 2024. The top 50 drugs were analyzed for annual reporting trends using linear regression. Disproportionality analysis using the reporting odds ratio (ROR) method, with P -values adjusted via Bonferroni correction, identified significant signals, which were then validated against drug labels and re-evaluated using the CVAR database. Time-to-onset analysis was also performed. Results From 2004 to Q1 2024, FAERS recorded 17,785,793 AEs, with 16,183 (0.09%) identified as UR cases. The median age among these cases was 65 years, with males comprising 53.4%. There were significant annual increases in UR reports associated with antineoplastic agents (0.19% per year) and antidiabetic drugs (0.09% per year), while reports linked to bronchodilators decreased (−0.53% per year). Disproportionality analysis revealed significant signals for 34 drugs (68%), with the highest RORs observed in Fesoterodine, Mirabegron, and Solifenacin. Initial signal detection identified potential new UR signals for Abiraterone, Valacyclovir, Fluoxetine, Empagliflozin, Clopidogrel, and Amlodipine, with CVAR confirming signals for Abiraterone, Fluoxetine, and Empagliflozin. The median time to onset of UR was 29 days, with over half of the cases occurring within 30 days of initiating medication. Conclusion The study identifies a rising trend in drug-related UR reports over the past 2 decades. The validation of new signals for Abiraterone, Fluoxetine, and Empagliflozin underscores the critical need for continuous drug safety monitoring and targeted research to better understand the mechanisms behind drug-induced UR.

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