Silodosin 4mg capsules

PURPOSE: To perform a systematic review and meta-analysis evaluating the efficacy and safety of preoperative silodosin in improving ureteroscopy (URS) outcomes for ureterolithiasis. MATERIALS AND METHODS: PubMed, EMBASE and Cochrane Central were systematically searched for studies comparing preoperative silodosin with placebo or 'no preoperative silodosin' in patients undergoing URS for ureteral stones. Primary outcomes included ureteral wall injury, analgesia use, fever, haematuria, stone-free rate (SFR), operative time, and complications. Statistical analysis was performed using Review Manager 5.1.7. Study quality and risk of bias were assessed per Cochrane guidelines. RESULTS: Nine studies, including eight randomized clinical trials, including 960 patients were analysed; 450 (46.8%) received silodosin. Compared to controls, silodosin significantly reduced ureteral injuries (RR 0.30; 95% CI: 0.18-0.49; p < 0.00001) and operative time (MD -17.72 minutes; 95% CI: -24.72 to -10.72; p < 0.00001). It also lowered analgesia needs (RR 0.35; 95% CI: 0.16-0.75; p = 0.007), with trends toward reduced fever (RR 0.67; 95% CI: 0.36-1.22; p = 0.19) and haematuria (RR 0.57; 95% CI: 0.32-1.02; p = 0.06). In studies with ≥10 days of preoperative use, silodosin significantly improved SFR (RR 1.17; 95% CI: 1.10-1.26; p < 0.00001). CONCLUSIONS: Preoperative silodosin reduces ureteral injuries, operative time, and complications, supporting its use to improve safety and efficiency of URS for ureterolithiasis.

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I read with great interest an article published by Ramadhani et al.[1] in the latest edition of the Journal. In this study, the authors have performed a systematic review and meta-analysis of the studies examining the role of silodosin as a medical expulsive therapy for distal ureteric stones. I would like to congratulate the authors on their publication. Multiple randomized control trials have established the efficacy of alpha-blockers as a part of medical expulsive therapy for distal ureteric stones. Most of the studies conducted in this field have been small, single-center, poor-quality randomized studies. Therefore, there is still a scope for a well-conducted multicentric randomized control trial to close this debate. This is where systematic reviews and meta-analyses have proved handy by performing a pooled analysis of these small randomized studies. However, this pooling of data may not be without limitations as there would be heterogeneity in the patient population and outcomes studied. In the present meta-analysis, the authors have tried to handle this delicate issue; however, there are still limitations that need to be addressed. One important limitation of this study that needs to be highlighted is the fact that the placebo or control group was different in the included studies. Most of the included studies did not include a classical “placebo” group but instead had a no-treatment group with hydration with or without anti-inflammatory drugs as control. Second, the authors have included a study by Rathi et al.,[2] which was actually a conference abstract. In the methods’ section, the authors have not adequately highlighted how they handled conference abstracts. Were the data readily available from the study by Rathi et al. to perform pooled and risk-of-bias analysis or did the authors have to contact the original study author for full-text? In any situation, it is generally recommended that conference abstracts should not be included in the systematic reviews as they do not undergo a stringent peer-review process. Furthermore, I have reservations over the inclusion of a study by Cholaraju et al.[3] in the present review. This study did not clearly define the randomization technique and outcome parameters. None of the previous reviews have included this study and we also excluded this study from our two published reviews on the topic due to the reasons mentioned above.[4–6] Heterogeneity due to imaging modality and duration for determining stone-free rate is also an important factor to consider and should have been highlighted in the limitations section. Finally, the authors have not clarified in the introduction section regarding the need for this study. What was the knowledge gap in the literature for which they developed the research question for this study? In my opinion, the study question has been a part of multiple reviews with similar findings published in the past, thereby suggesting redundancy of the current review.[5–10] Furthermore, the authors have not compared their results with the results of previous studies in the discussion section, which in my opinion are not much different from that of the present study. For instance, in a previous network meta-analysis by Sharma et al., comparing three commonly used alpha-blockers for distal ureteric stones, silodosin was noted to be the most efficacious drug.[6] Further minor issues that need rectification/clarification include: References to the included studies cited in Table 1 seem to be incorrect The authors have been quite generous in the risk of bias analysis as most of the included studies were of low quality In Figure 3, instead of fixed-effect analysis, the random-effect analysis should have been used as there was a significant statistical heterogeneity. The authors should also include publication bias either by Funnel plot or by Egger’s method. Financial support and sponsorship: Nil. Conflicts of interest: There are no conflicts of interest.

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PURPOSE: This study aimed to evaluate the efficacy of the α1 adrenergic receptor antagonist silodosin in preventing lower urinary tract symptoms after rectal cancer surgery. METHODS: We conducted a 2-arm, double-blind, single-center randomized controlled trial. The study included 150 patients with rectal cancer who underwent radical surgery between 2019 and 2022. On the first postoperative day, the urinary catheter was removed for all patients. Of these, 100 patients were administered silodosin, while 50 patients (control group) receive placebo (glucose tablet). Urinary dysfunction (urinary retention, infection, dysuria) and other complications were monitored. RESULTS: Among the 150 patients, 84 (56.0%) were male and 66 (44.0%) were female. Surgical procedures included abdominoperineal resection in 33 patients, partial mesorectal excision in 45, and total mesorectal excision in 72. A laparoscopic approach was used in 69 patients, while the remaining 81 underwent open surgery. Urinary tract symptoms developed in 10 patients (6.7%): 7 (7.0%) in the silodosin group and 3 (6.0%) in the control group (P=0.92). In the silodosin group, there was 1 case (1.0%) of urinary retention, 3 cases (3.0%) of urinary tract infection, and 3 cases (3.0%) of dysuria. In the control group, there was 1 case (2.0%) each of urinary retention, urinary tract infection, and dysuria (all P=0.92). CONCLUSION: Early urinary catheter removal on the first postoperative day was safe in both groups. The use of the oral α-antagonist silodosin did not provide additional benefits in preventing lower urinary tract symptoms in patients undergoing rectal cancer surgery. Trial registration: ClinicalTrials.gov identifier: NCT03607370.

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BACKGROUND: Premature ejaculation (PE) is a prevalent male sexual dysfunction with limited comparative data on pharmacological treatments. This randomized clinical trial aimed to evaluate the efficacy and safety of four active pharmacological interventions for lifelong PE. METHODS: A prospective randomized trial was conducted from June 2024 to March 2025 at Beni-Suef University Hospital. Four hundred eligible patients diagnosed with lifelong PE were randomly allocated to one of four active treatment groups (n = 100 per group): (1) citalopram 20 mg/day, (2) silodosin 4 mg/day, (3) dapoxetine 30 mg on-demand (1-3 h before intercourse), or (4) dapoxetine 30 mg daily. The primary outcome was the change in intravaginal ejaculatory latency time (IELT) measured by stopwatch. Secondary outcomes included changes in the Premature Ejaculation Profile Questionnaire (PEPQ) scores and the incidence of treatment-emergent adverse events. Statistical analysis was performed using ANOVA with post-hoc tests for continuous variables and chi-square tests for categorical data. RESULTS: All four treatment groups demonstrated significant within-group improvements in IELT from baseline (p < 0.001 for all). The citalopram group exhibited the greatest mean IELT increase (from 110.4 ± 31.5s to 391.2 ± 45.9s; 260% median gain), outperforming the daily dapoxetine (220%), on-demand dapoxetine (197%), and silodosin (149.5%) groups. Improvements in PEPQ scores mirrored the IELT findings, with citalopram showing a 300% improvement compared to 225%, 166.7%, and 175% in the daily dapoxetine, on-demand dapoxetine, and silodosin groups, respectively. In inter-group comparisons, citalopram was superior to silodosin in all PEPQ domains (p < 0.001) and to both dapoxetine regimens in the domain of interpersonal difficulty (p < 0.01). Adverse event profiles differed: silodosin was associated with a higher incidence of ejaculatory dysfunction (23% retrograde ejaculation), while daily dapoxetine led to more systemic effects (18% dizziness). CONCLUSION: In this direct head-to-head comparison of active treatments for lifelong PE, daily citalopram (20 mg) demonstrated superior efficacy in prolonging IELT and improving psychosocial outcomes compared to daily or on-demand dapoxetine and silodosin. The findings suggest that citalopram is a highly effective first-line option, while the dose-dependent efficacy of dapoxetine and the distinct side-effect profile of silodosin provide alternative considerations for personalized treatment strategies. TRIAL REGISTRATION: This clinical trial was registered at ClinicalTrials.gov (Identifier NCT07113145) on 7 August 2025 after the enrollment of the first participant and is therefore retrospectively registered."

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Background: In men with progressive benign prostatic hyperplasia (BPH), acute urine retention (AUR) stands out as one of the most severe outcomes associated with aging. AUR is characterized by a sudden, painful inability to urinate. This research investigates the potential benefits of adding pyridostigmine to silodosin in the management of acute urinary retention secondary to benign prostatic hyperplasia. Methods: Patients aged 50 and above experiencing their first episode of AUR due to BPH, with a retention volume below 1000 milliliters, were enrolled in this study. A total of 140 patients were randomized into two groups: Group A received a daily dose of pyridostigmine bromide (60 mg tablet) alongside an 8 mg silodosin capsule, while Group B received a daily dose of silodosin (8 mg capsule) only. Trial registration number: NCT06319469 13 March 2024. Results: Among the 140 patients, 58 (82.9%) in Group A successfully underwent a trial without catheter (TWOC), compared to 47 (67.1%) in Group B. Group A exhibited significant improvements in international prostatic symptom score (IPSS) and uroflowmetry (UFR) at both 2 weeks and 3 months, with p-values of 0.001 and 0.003, respectively. Regarding postvoid residual volume (PVR), both groups were initially matched at baseline, showing significant continuous improvement at the second week and third month. Conclusions: The combination of pyridostigmine bromide (60 mg tablet) with silodosin proved to be more effective than silodosin alone in managing acute urinary retention caused by BPH. This was particularly true for patients who were suspected to have detrusor underactivity in addition to BPH.

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Background: Medical expulsive therapy (MET) helps patients with lower ureteric calculi (LUC) pass their stones more easily. Although tadalafil and silodosin are promising MET agents, it is yet unknown how effective they are in comparison. The treatment efficacy of these medicines in LUC patients was compared in the current investigation. Methods: 90 patients were divided into two groups at random and given tadalafil (Group B) and silodosin (Group A) as prospective treatments. Every patient's age, sex, stone type, size, ejection rate, and pain episodes were noted and examined. Results: Groups A and B had mean ages of 39.1 (± 8.0) and 37.4 (± 8.2) years, respectively. With mean BMI values (kg/m2) of 27.1 (± 1.7) and 27.5 (± 1.6) for Groups A and B, respectively, the groups' sex distribution and comorbidities were comparable. Additionally, the mean stone type (radiopaque: 75.6% vs. 80.0%) and size (7.6 mm vs. 7.8 mm) were comparable. Silodosin treatment, however, resulted in a lower use of analgesics (198.8 mg vs. 247.8 mg, p &lt; 0.001), fewer pain episodes (1.1 vs. 2.5, p &lt; 0.001), and a greater expulsion rate (80.0% vs. 60.0%) and shorter expulsion duration (14.4 vs. 17.7 days, p &lt; 0.001). With the exception of frequent irregular ejaculation with silodosin (17.8% vs. 4.4%), the side effects were comparable. Conclusion: In conclusion, even though silodosin is linked to an increased risk of irregular ejaculation, it is superior to tadalafil in encouraging stone removal while lowering pain episodes. Clinical Trial Registration: CTRI/2025/03/082491

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Silodosin, a highly selective α1A-adrenoceptor blocker, is an effective treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Despite its growing use, there remains a lack of comprehensive evidence evaluating the efficacy/effectiveness and safety of silodosin in BPH patients, especially in patients with comorbidities. This review aimed to synthesize recent clinical evidence on the efficacy/effectiveness and overall safety of silodosin in treating BPH. The PubMed literature search identified 23 articles (clinical trials: n = 18; observational studies: n = 5) published between 2014-2024 for inclusion. Silodosin alone (n = 4) significantly improved urological outcomes and alleviated LUTS in BPH patients. In total, 19 studies examined the efficacy/effectiveness of silodosin compared with placebo (n = 2) or various pharmacological treatments (n = 17) for BPH, including other α1-adrenoceptor blockers and combination therapies. Silodosin reduced nocturia in BPH patients (n = 5). In BPH patients with comorbidities such as heart diseases, silodosin alleviated LUTS and enhanced quality of life (n = 5). Across 21 studies evaluating safety, silodosin was well-tolerated; the frequency of retrograde ejaculation/ejaculatory disorder ranged from 0.85% to 34.4%. Notably, the selective action of silodosin on α1A-adrenergic receptors was associated with minimal cardiovascular adverse events. This review demonstrated that silodosin is efficacious/effective and well-tolerated in BPH patients, including patients with cardiovascular comorbidities.

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