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Introduction: The use of a ureteral access sheath (UAS) during ureteroscopy (URS) has been associated with the risk for ureteral injuries. Preoperative administration of α1-blockers presents a potential mitigator of such lesions by inducing ureteral relaxation, which may also contribute to improving other surgical outcomes. Methods: A comprehensive literature search was conducted across MEDLINE, Embase, and Cochrane databases for studies comparing preoperative α1-blockers administration vs its non-use in adult patients without pre-stenting undergoing URS. Binary outcomes were evaluated using risk ratios (RRs) and odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was measured with the Cochran's Q test, I2 statistics, and prediction intervals (PIs). A DerSimonian and Laird random-effects model was utilized for all outcomes. Results: Eleven studies encompassing 1074 patients undergoing URS were included, of whom 522 (48.60%) received α1-blockers before the procedure. Preoperative α1-blockers were associated with a reduction in significant ureteral injuries (RR 0.30; 95% CI 0.17–0.53; I2 = 6%; PI 0.10–0.88) and an increase in mean successful UAS insertion (OR 2.14; 95% CI 1.08–4.23; I2 = 23%; PI 0.51–8.93). In patients undergoing exclusively ureteroscopy lithotripsy (URSL), the medications also reduced total complications (RR 0.62; 95% CI 0.46–0.84; I2 = 0%) and complications graded Clavien–Dindo III or higher (RR 0.16; 95% CI 0.04–0.69; I2 = 0%), but no significant difference between groups was found in the stone-free rate (RR 1.10; 95% CI 0.86–1.40; I2 = 91%; PI 0.47–2.59). Conclusion: Preoperative α1-blockers were linked to a decrease in significant ureteral injuries with UAS use and fewer complications during URSL procedures. However, their impact on the successful insertion of a UAS remains uncertain. Consideration of administering preoperative α1-blockers in non-stented adult patients undergoing URS with UAS is advisable. [ABSTRACT FROM AUTHOR]

Abstract Objectives This work aims to determine the efficacy and safety of preoperative alpha‐blocker therapy on ureteroscopy (URS) outcomes. Methods In this systematic review and meta‐analysis of randomised trials of URS with or without preoperative alpha‐blocker therapy, outcomes included the need for ureteral dilatation, stone access failure, procedure time, residual stone rate, hospital stay, and complications. Residual stone rates were reported with and without adjustments for spontaneous stone passage, medication noncompliance, or adverse events leading to patient withdrawal. Data were analysed using random‐effects meta‐analysis and meta‐regression. Certainty of evidence was assessed using the GRADE criteria. Results Among 15 randomised trials with 1653 patients, URS was effective and safe with a stone‐free rate of 81.2% and rare (2.3%) serious complications. The addition of preoperative alpha‐blockers reduced the need for ureteral dilatation (risk ratio [RR] = 0.48; 95% CI = 0.30 to 0.75; p = 0.002), access failure rate (RR = 0.36; 95% CI = 0.23 to 0.57; p

Objective: To evaluate efficacy and safety of either or both silodosin and mirabegron as MET for distal ureteric stones ≤ 10 mm. Patients and methods: This study enrolled a total of 105 patients, aged between 20 and 56 years, diagnosed by single radiopaque distal ureteral stone measuring ≤ 10 mm. The recruitment period spanned from May 2020 to December 2021. The patients were randomly divided into three groups, with each group consisting of 35 participants. Group A received a once-daily dose of 8 mg of silodosin, group B received a once-daily dose of 50 mg of mirabegron, and group C received a combination of both medications. Treatment was administered to all patients until the stone was expelled or for a maximum duration of four weeks. The stone-free rate was determined by analyzing KUB films with or without ultrasonography. Results: The rate of stone expulsion was significantly higher in group C compared to groups A and B (P = 0.04 and P = 0.004, respectively). The mean (standard deviation) time for stone expulsion in groups A, B, and C was 14 ± 2.3 days, 11 ± 3.1 days, and 7 ± 2.2 days, respectively. Group C demonstrated a significantly shorter stone expulsion time compared to groups A and B (P = 0.001 and P = 0.04, respectively). The frequency of renal colic in group C was significantly lower than that in groups A and B, resulting in a reduced requirement for analgesics (P < 0.05). Anejaculation occurred at a significantly higher rate in the silodosin group (73.9%) and combination group (84%) compared to the mirabegron group (P < 0.05). Conclusions: The findings of this study suggest that both silodosin and mirabegron are effective treatments for the expulsion of lower ureteric stones. Furthermore, the combination of these medications leads to an increased rate of stone expulsion and a reduced duration of expulsion. [ABSTRACT FROM AUTHOR]

Introduction In this study we aimed to compare the efficacy of mirabegron and silodosin as medical expulsive therapy (MET) for distal ureteric calculus ≤10 mm. Material and methods A total of 114 patients who met the inclusion criteria were prospectively randomised into 2 groups, 58 patients in the silodosin group and 56 patients in the mirabegron group. The drugs were given for a maximum of 4 weeks. The primary endpoint was the stone expulsion rate, and secondary endpoints were stone expulsion time and number of pain episodes. Results There were no statistically significant differences between the two groups in terms of mean age, gender, mean stone size, side, or hydronephrosis. Both groups exhibited similar rates of stone expulsion and expulsion time. Regarding pain management, the frequency of renal colic episodes was significantly lower with mirabegron compared to silodosin (2.3 ±0.2 vs 1.9 ±0.2, P <0.0001). Six patients were excluded from the study due to adverse drug reactions: 4 (6.15%) in the silodosin group (retrograde ejaculation, hypotension) and 2 (3.27%) in the mirabegron group (hypertension). Conclusions In among patients with distal ureteric stones measuring 5–10 mm, mirabegron did not demonstrate superiority in stone expulsion rate or expulsion time compared to silodosin. However, mirabegron significantly reduced the frequency of renal colic episodes. Therefore, mirabegron may be considered a preferable option for medical expulsive therapy for distal ureter stones over silodosin. [ABSTRACT FROM AUTHOR]

The current research developed a high‐performance thin layer chromatographic method based on green analytical chemistry and integrated experimental approaches of analytical quality by design for simultaneous estimation of solifenacin succinate and silodosin. The integration was planned to reduce energy and solvent usage, maximize efficacy, and minimize any negative environmental effects. Taguchi design for screening and optimization a Box–Behnken design was used. The n‐butanol:ethanol:triethylamine (6:4:0.1, v/v/v) mobile phase and ultraviolet detection at 221 nm were used to develop the method. As per International Council for Harmonization Q2(R1) specifications, the method was validated. Rf value for solifenacin succinate and silodosin was found to be 0.29 ± 0.02 and 0.58 ± 0.02 respectively. For solifenacin succinate and silodosin, the linearity was found over the concentration ranges of 500–2500 ng/band and 800–4000 ng/band. For solifenacin succinate, the limits of detection and quantification were found to be 13.00 and 39.34 ng/band, respectively, while for silodosin, they were 33.29 and 100.86 ng/band, respectively. For solifenacin succinate, the method revealed a percent recovery ranging from 98.49% to 99.50%, while for silodosin, it exhibited a range from 98.86% to 99.79%. The tools predicted greenness score to be 63 and 0.78, respectively, indicating the proposed method to be green. [ABSTRACT FROM AUTHOR]

Purpose: To assess whether preoperative administration of silodosin can facilitate the placement of ureteral access sheath (UAS) prior to flexible ureteroscopy (F-URS) and reduce the occurrence of ureteric injury in challenging cases. Methods: This prospective randomized clinical trial was carried out on 147 patients diagnosed with upper ureteric stone or stone kidney, non-stented. The patients were randomly divided into two equal groups. Group A (silodosin group) included patients in whom F-URS was done with daily preoperative intake of 8 mg silodosin for 1 week and group B (placebo/control group) included patients in whom F-URS was done with daily preoperative intake of placebo tablets. Results: In group A, a total of 23 (33.3%) experienced ureteral wall injury following UAS insertion, while in group B, this occurred in 40 patients (59.7%). There was a statistically significant difference in the grade of ureteral wall injury between the two groups (P < 0.001). In the multiple regression analysis, age, operative time and silodosin were found to be significant risk factors for ureteral wall injury (P = 0.007, 0.041 and < 0.001, respectively). Conclusions: The administration of silodosin prior to retrograde intrarenal surgery (RIRS) effectively prevented significant ureteral wall damage and reduced initial postoperative discomfort. [ABSTRACT FROM AUTHOR]

Background: To study the impact of early in comparison to late catheter removal following acute urine retention (AUR) secondary to benign prostatic hyperplasia (BPH) using silodosin therapy on the outcome of trial without catheter (TWOC). Methods: Two hundred sixty patients with AUR 2ry to BPH were catheterized then were randomly divided to receive silodosin 8 mg either for three or 7 days followed by catheter removal and successful voiding unaided was assessed. Results: Out of the 260 men (mean age 64.8 ± 6.5 years) treated, 74 men who were receiving 3 days of silodosin and 88 patients who were receiving 7 days of silodosin didn't require re-catheterization on the day of TWOC (57% and 68% respectively, p = 0.096). Complications like urinary leakage, acute urinary tract infection, hematuria, or catheter blockage recorded in 21 men (16.2%) who received 3 days of silodosin, and in 63 men (48.5%) who received 7 days of silodosin (p ⩽ 0.001). Conclusion: Patients catheterized after AUR 2ry to BPH can spontaneously void following catheter removal if treated by silodosin, independent of the catheterization duration, while side effects have increased with prolonged catheterization. [ABSTRACT FROM AUTHOR]

Background: The existence of β3 receptors in the bladder and ureter was documented in many studies on animals and humans, it was documented that relaxation of the lower ureteral segment is achieved by the stimulation of these receptors. Our aim was to assess the efficacy and safety of mirabegron as a medical expulsive therapy (MET) for distal ureteral stones in comparison with silodosin and placebo. Methods: One hundred eighty patients with distal ureteral stone of 5–10 mm size were included in our study. They were divided into three groups, and each one consisted of 60 patients. Group I was given silodosin 8 mg, group II mirabegron 50 mg and group III placebo once daily. The treatment was prescribed for all the cases till stone expulsion or a maximum duration of 4 weeks. Primary outcome was the stone expulsion rate (SER). While secondary outcomes were stone expulsion time, side effects of the used drugs, hospital visits number for pain, and amount of analgesic taken. Results: We found that the SER was significantly higher in silodosin than mirabegron and placebo groups (61%, 38.6%, and 36.7%, respectively) (p = 0.013). Also, the stone expulsion interval was significantly shorter in silodosin than mirabegron and control groups (p < 0.001). While hospital visits number for pain, and amount of analgesic taken were comparable. There was no difference between the studied medications in terms of the adverse effects except for retrograde ejaculation (silodosin = 63.3%, mirabegron = 0%, and placebo = 0%; p < 0.001). Conclusion: Mirabegron has no medical expulsive effect. While silodosin improves SER and stone expulsion time. However, retrograde ejaculation was its main side effect and occurred in 63.3% of the male patients. Therefore, more research is needed to discover a more tolerable MET. [ABSTRACT FROM AUTHOR]

Background: Men with overactive bladder (OAB) and benign prostatic hyperplasia (BPH), will have deterioration in the quality of life. Objective: The aim of this study was to evaluate the effect of combining pelvic floor muscle training with the urgency suppression technique (PFMT-st) and silodosin in comparison with silodosin in men with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) after 12 weeks of treatment. Patients and methods: A total of 158 patients were randomized into two groups. The control group received oral silodosin at a daily dose of 8 mg. The experimental group was administered PFMT-st and silodosin. The evaluation methods included the number of voids and intensity of urgencies over 24 h using a micturition diary, the International Prostate Symptom Score (IPSS), the Overactive Bladder Questionnaire (OAB-q), and the patient global impression of improvement (PGI-I). Results: 142 of 172 (86.6%) men were assessed (70 in the control group, 72 in the experimental group). The significant changes were in favor of the experimental group (p < 0.001) in the number of voids per 24 h (− 1.95 ± 1.94 vs. − 0.90 ± 1.44), the OAB-q symptom score (− 14.25 ± 10.05 vs. − 9.28 ± 10.60), the intensity of urgencies (− 0.97 ± 0.53 vs. 0.24 ± 0.57), the IPSS (− 4.59 ± 3.00 vs. − 2.30 ± 3.63), and in the PGI-I (2.24 ± 0.79 vs. 3.60 ± 0.92). Conclusions: The addition of PFMT-st to silodosin treatment significantly improved OAB in men with BPH. This is the first study to confirm that PFMT-st should be the first-choice treatment for OAB in BPH. [ABSTRACT FROM AUTHOR]

Purpose: The present paper takes a different and more critical look at the role of alpha-blockers, sometimes nicknamed as “magical pills”, in particular for stone disease and medical expulsive therapy (MET). Methods: A non-systematic narrative review was performed, synthesizing pertinent information from selected articles, and critically evaluating their conclusions. Sometimes different views on alpha-blockers were laid bare, including curiosities or other entertaining nuances suitable to the present topic, but always maintaining sharp objectivity and the foremost scientific rigor. Results and Conclusions: Alpha-blockers seem to be a panacea, being used to treat a wide variety of non-urological diseases and conditions. Urological applications include erectile dysfunction to benign prostatic hyperplasia, from incontinence to urinary retention, or even to facilitate urinary stone passage along the urinary tract. Due to its versatility, alpha-blockers appear to be the Swiss army knife of urological medications. However, the efficacy of alpha-blockers for MET, pain management, or facilitating upper tract access is very disappointing, bringing no, or in some instances, only marginal benefits. Their treatment results are far from being significant or impressive let alone magical. Regular sexual intercourse is an effective alternative to alpha-blockers, providing faster ureteral stone expulsion rates and reducing the need for pain medication. Most of the research supporting alpha-blockers has been based on single-center, underpowered, low-quality studies. These low-quality studies biased several subsequent meta-analyses, contaminating them with their low-quality data, enhancing and prolonging this delusion. These results emphasize the need for large, multi-centric, unbiased, randomized, double-blinded, placebo-controlled trials to prevent future year-long delusions that may afflict any medical field. [ABSTRACT FROM AUTHOR]

BACKGROUND Ureteral stones are a common urological condition causing significant discomfort and morbidity. Medical expulsive therapy (MET) is a noninvasive approach to facilitate the passage of stones. This study aimed to compare the efficacy and safety of silodosin and tamsulosin as MET in patients with distal ureteral stones (DUS). METHODS We searched CINAHL, Cochrane Library, PubMed, and ScienceDirect for randomized controlled trials (RCTs) on the administration of silodosin and tamsulosin for DUS. The primary outcomes analyzed were stone expulsion rates and expulsion times, measured as risk ratio (RR) and mean difference (MD), respectively. Statistical analyses were performed using Review Manager 5.4 and STATA 17. RESULTS 14 RCTs comprising 1,535 patients (770 received silodosin) met the inclusion criteria. The silodosin group had notably higher stone expulsion rates (RR 1.20, 95% confidence interval [CI] 1.13-1.27, p<0.00001, I² = 37%), shorter expulsion times (MD -2.98, 95% CI -4.35-1.62, p<0.01, I² = 85%), and fewer colicky pain episodes (MD -0.35, 95% CI -0.59-0.10, p<0.01, I² = 83%) than the tamsulosin group. Retrograde ejaculation was the only adverse event that had a significant difference between both groups, statistically favoring tamsulosin (RR 1.61, 95% CI 1.12-2.33, p = 0.01, I² = 0%). CONCLUSIONS Silodosin should be preferred as the first-line MET agent for DUS owing to its better expulsion rate, shorter stone expulsion time, and fewer colicky pain episodes. However, tamsulosin may be used in selected cases where patients experience retrograde ejaculation after receiving silodosin. [ABSTRACT FROM AUTHOR]

To evaluate the impact of silodosin on stages of flexible ureteroscopy (F-URS) procedures, complications, and stone-free rate (SFR). A prospective, randomized, controlled comparison research was conducted on 106 patients who were randomly allocated into two groups: the study group (52 patients) received F-URS with preoperative daily uptake of 8 mg silodosin for 10 days, and the control group (54 patients) received F- URS without silodosin uptake. Two patients were lost during the follow up in the study group and four patients were also lost in the controls. Operative time, application access sheath time (AAST), entrance to ureteric orifice time (ETUOT), and entrance to bladder time (ETBT) were significantly lower in the study group compared to controls. Meanwhile, F-URS time & laser time was higher in the study group compared to controls but without statistically significant difference. Complications were insignificalty different between both studied goups with no impact on SFR. Before ureteroscopy, silodosin, an adjunctive alpha-blocker therapy, was successful in treating stones resulting in shortening the procedural time, with no impact on SFR or complication rate. [ABSTRACT FROM AUTHOR]

Background: An association between adrenergic alpha-1 receptor antagonists and delirium has been suggested, but the details are unclear. Aim: This study investigated the association between adrenergic alpha-1 receptor antagonists and delirium in patients with benign prostatic hyperplasia using the Japanese Adverse Drug Event Report database. Method: First, disproportionality analysis compared the frequency of delirium in the adrenergic alpha-1 receptor antagonists silodosin, tamsulosin, and naftopidil. Next, multivariate logistic analysis was performed to examine the association between delirium and adrenergic alpha-1 receptor antagonists where disproportionality was detected. Results: A disproportionality in delirium was observed in patients receiving tamsulosin (reporting odds ratio [ROR] 1.85, 95% confidence interval [CI] 1.38–2.44, P < 0.01) compared with those who did not, and also in patients receiving naftopidil (ROR 2.23, 95% CI 1.45–3.28, P < 0.01) compared with those who did not. Multivariate logistic analysis revealed that in addition to previously reported risk factors for delirium, delirium in patients receiving tamsulosin was significantly increased with concomitant use of anticholinergics (odds ratio 2.73, 95% CI 1.41–5.29, P < 0.01) and delirium in patients receiving naftopidil was significantly increased with concomitant use of beta3-adrenergic receptor agonists (odds ratio 4.19, 95% CI 1.66–10.6, P < 0.01). Conclusion: Anticholinergics or beta3-adrenergic receptor agonists to treat overactive bladder in patients receiving tamsulosin and naftopidil was strongly associated with delirium. Confirming the medical history and concomitant medications of patients receiving tamsulosin or naftopidil may contribute to preventing delirium in patients with benign prostatic hyperplasia and to improving their outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Medical Expulsive Therapy (MET) involves the utilisation of different drugs that act on the ureter through various mechanisms. Alpha-1 adrenoceptor and Phosphodiesterase (PDE) regulate ureteric motility thus combination of these drugs can increase the ureteric stone expulsion rate by complementing each other's actions. Aim: To assess the synergistic role of alpha-blocker and Tadalafil therapy in facilitating the spontaneous expulsion of distal ureteral stones. Materials and Methods: A prospective cohort study was conducted in the Department of Urology at a Tertiary Care Centre (NSCB Medical College) from April 2020 to January 2022. A total of 281 patients diagnosed with lower ureteric stones (5-10 mm) were divided into five study groups: Group A was treated with tamsulosin, group B with silodosin, group C with tadalafil alone, group D with tamsulosin and tadalafil, and group E treated with a combination of silodosin and tadalafil. Corticosteroid (deflazacort 6 mg) was also included in every group. All patients were reassessed after three weeks of treatment for stone expulsion rate, expulsion time, the number of hospital visits for pain, and adverse effects of drugs. The statistical data was analysed using Statistical Package for Social Sciences (SPSS) software (version 21.0, IBM Corp, USA). The Chi-square test and Analysis of Variance (ANOVA) test were used to determine the effect on stone expulsion rate and expulsion time. The confidence interval was 95%, and the significance level of the p-value was set <0.05. Results: The stone expulsion rates in group A, B, C, D, and E were 70.91%, 79.63%, 52.63%, 84.21%, and 86.20%, respectively, which was significant (p=0.00194). The mean time taken for stone expulsion in group A, B, C, D, and E were 8.95±1.73, 8.43±1.57, 9.86±1.90, 7.96±2.03, and 7.75±1.84 days (p=0.0001). Minor side effects were not significant, except for retrograde ejaculation in group B and E, and 22.8% of patients needed hospitalisation in group C (tadalafil alone). Conclusion: Combination therapy is safe, efficacious, and well-tolerated as MET for distal ureteric calculi in the 5-10 mm range, thereby avoiding surgical procedures and providing faster relief for the patients. [ABSTRACT FROM AUTHOR]

Two unknown impurities were detected during the related substance analysis of the Silodosin crude sample using High- Performance Liquid Chromatography. These impurities were isolated using preparative HPLC and then subjected to LCMS for mass determination. Structural elucidation has been carried out using NMR (¹H NMR, 13C NMR) spectroscopy. These impurities were discovered to have a structural alert, which was confirmed by the Insilico prediction model indicating that they were Potentially Genotoxic Impurities (PGI's). A genotoxic assessment of these impurities was done using the Insilico prediction model for genotoxicity (VEGA and Toxtree). These impurities have not been reported elsewhere, to the best of our knowledge. Thus, a HPLC-UV method was developed and validated for the determination of these impurities at the TTC level. The proposed method was validated in terms of Specificity, Precision, Accuracy, Linearity and Robustness as per ICH guidelines. The LOD and LOQ of the method were established to be 0.0018 ppm and 0.055 ppm with respect to test concentration (1000 µg mL-1 silodosin). [ABSTRACT FROM AUTHOR]

Introduction: Medical Expulsive Therapy (MET) involves the utilisation of different drugs that act on the ureter through various mechanisms. Alpha-1 adrenoceptor and Phosphodiesterase (PDE) regulate ureteric motility thus combination of these drugs can increase the ureteric stone expulsion rate by complementing each other’s actions. Aim: To assess the synergistic role of alpha-blocker and Tadalafil therapy in facilitating the spontaneous expulsion of distal ureteral stones. Materials and Methods: A prospective cohort study was conducted in the Department of Urology at a Tertiary Care Centre (NSCB Medical College) from April 2020 to January 2022. A total of 281 patients diagnosed with lower ureteric stones (5-10 mm) were divided into five study groups: Group A was treated with tamsulosin, group B with silodosin, group C with tadalafil alone, group D with tamsulosin and tadalafil, and group E treated with a combination of silodosin and tadalafil. Corticosteroid (deflazacort 6 mg) was also included in every group. All patients were reassessed after three weeks of treatment for stone expulsion rate, expulsion time, the number of hospital visits for pain, and adverse effects of drugs. The statistical data was analysed using Statistical Package for Social Sciences (SPSS) software (version 21.0, IBM Corp, USA). The Chi-square test and Analysis of Variance (ANOVA) test were used to determine the effect on stone expulsion rate and expulsion time. The confidence interval was 95%, and the significance level of the p-value was set

Luo Jindan,&ast; Wang Xiao,&ast; Xie Liping Department of Urology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Xie Liping, Department of Urology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China, Email xielp@zju.edu.cnAbstract: Use of α-androgenic receptor blockers remains a mainstay therapeutic approach for the treatment of urological diseases. Silodosin is recommended over other α-blockers for the treatment of lower urinary tract symptoms (LUTS) and benign prostate hyperplasia (BPH), due to its high α1A uroselectivity. Current research data suggest that silodosin is efficacious in the management of various urological diseases. Thus, we herein review the current evidence of silodosin related to its efficacy and tolerability and appraise the available literature that might ultimately aid in management of various urological conditions at routine clinical practice. Literature reveals that silodosin is beneficial in improving nocturia events related to LUTS/BPH. Silodosin exerts effect on relaxing muscles involved in detrusor obstruction, therefore prolonging the need for patients undergoing invasive surgery. Silodosin treatment, either as a monotherapy or combination, significantly improves International Prostate Symptom Score (IPSS) including both storage and voiding symptoms in patients with BPH/LUTS. Patients on other treatment therapies such as phosphodiesterase 5 inhibitors or other α-blockers are well managed with this drug. Steadily, silodosin has proved beneficial in the treatment of other urological disorders such as chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), overactive bladder/acute urinary retention (AUR), premature ejaculation (PE), and prostate cancer post brachytherapy-induced progression. In patients with distal ureteral stones, silodosin treatment is beneficial in decreasing stone expulsion time without affecting stone expulsion rate or analgesic need. Moreover, there were significant improvements in intravaginal ejaculation latency time, quality of life scores, and decrease in PE profile among patients with PE. Silodosin has also demonstrated promising results in increasing the likelihood of successful trial without catheter in patients with AUR and those taking antihypertensive drugs. Reports from Phase II studies have shown promising role of silodosin in the treatment of CP/CPPS as well as facilitating ureteral stone passage. From the robust data in this review, further silodosin treatment strategies in the management of different urological conditions need to be focused on.Keywords: efficacy, benign prostate hyperplasia, ureteral calculi, prostatitis, silodosin, urological

OBJECTIVE: To our knowledge, there is no study in the literature so far to investigate the effect of silodosin therapy on the ureteric jet parameters. Therefore, the objective of this study was to investigate the effect of silodosin 8 mg/day for medical therapy of lower urinary tract symptoms (LUTS) on the color flow Doppler parameters and patterns of the ureteric jets. PATIENTS AND METHODS: This prospective cohort study included 34 male patients who presented to our outpatient clinic with the complaint of lower urinary tract symptoms (LUTS) and received silodosin 8 mg once a day as medical therapy. In the color flow Doppler examinations, ureteric jets were observed and mean flow rate (JETave), maximum flow rate (JETmax), flow duration (JETdura), and flow frequency (JETfre) were examined. In addition, patterns of the ureteric jets (JETpat) were also evaluated. RESULTS: There was no statistically significant difference in JETave; however, JETmax, JETdura and JETfre were significantly higher at post-silodosin treatment. The patterns of ureteric jet were significantly changed following a 6-week treatment with silodosin (p<0.001). One ureter in the monophasic pattern group (9.1%) and three in the biphasic group (13.6%) turned to polyphasic pattern after silodosin use. None of the patients developed side effects that would require discontinuation of the drug. CONCLUSIONS: Six-week silodosin 8 mg/day therapy for the treatment of LUTS in men changed the parameters and patterns of ureteric jets at follow-up examination. Furthermore, comprehensive studies are needed on this issue. [ABSTRACT FROM AUTHOR]

A reliable HPLC method for the simultaneous estimation of Silodosin and Solifenacin was developed using the quality by design approach. In this study, the main goal was to find a dependable chromatographic system for acceptable component separation. The peaks were sharp within a reasonable run time. For the risk measurement related to the study, critical quality attributes were evaluated. To create an analytical design and a control strategy, the quantitative relationship between critical materials attributes and critical quality attributes was built utilizing the Box‐Behnken design. The optimum and ideal mobile phase ratio selected as per the quality by design approach was acetonitrile:methanol:buffer (50:20:30, v/v/v) which has a pH 4.5 flow rate of 1 ml/min. The buffer system used in this mobile phase was potassium dihydrogen orthophosphate. The retention time for Silodosin and Solifenacin determined was 3.626 and 5.754 min. respectively at λmax = 210 nm. The R2 value calculated for Silodosin and Solifenacin was 0.9994 and 0.9982, respectively. The related standard deviation was less than 2% for the developed method showing good reproducibility and recovery. A simple, precise, and repeatable high‐performance liquid chromatography method for regular quality control testing was developed simultaneously by applying a quality by design approach. [ABSTRACT FROM AUTHOR]

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Objectives: Pharmacological treatment options for underactive bladder (UAB) syndrome are limited. Urapidil is the only alpha1‐adrenoceptor (AR) antagonist that can be used for urinary disorders in women in some countries. However, no studies have directly verified the effects of alpha1‐AR antagonists on the female urethra and UAB‐like dysfunctions. We investigated the effects of silodosin (alpha1A‐AR antagonist) and urapidil (nonselective alpha1‐AR antagonist) on the voiding function in female rats with diabetes mellitus (DM). Methods: Changes in intraurethral pressure (IUP) induced by midodrine (alpha1‐AR agonist) and mean blood pressure (MBP) were continuously measured in normal female rats to verify the pharmacological profiles of the drugs. To establish a DM model, rats were administered streptozotocin (STZ; 50 mg/kg, intravenous). Eight weeks after STZ administration, drugs were subcutaneously delivered through an osmotic pump. Four weeks after drug administration, emptied bladder blood flow (BBF), intravesical pressure, and the micturition volume were measured. Results: Both silodosin and urapidil inhibited the midodrine‐induced increase in IUP and decreased MBP in a dose‐dependent manner. Silodosin had a more substantial effect on the lower urinary tract than on MBP. Twelve weeks after STZ administration, DM rats exhibited UAB‐like dysfunction (increased bladder capacity/bladder weight and residual volume and decreased bladder voided efficiency) and decreased BBF. Both drug treatments controlled this dysfunction. Conclusions: Alpha1‐AR antagonists induced dose‐dependent urethral relaxation in female rats. These drugs ameliorated UAB‐like dysfunction in STZ‐induced DM rats. In addition, alpha1A‐AR antagonists such as silodosin, which have limited effects on blood pressure, appear to be useful for treating UAB. [ABSTRACT FROM AUTHOR]

Purpose: Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) is a bladder-related chronic inflammatory disease. Data indicate that stress enhances the excitability of bladder nociceptors through the stimulation of alpha1A-adrenoceptors. Stress is known to play a crucial role in BPS/IC patients. We aimed to assess the efficacy and safety of daily silodosin in refractory BPS/IC female patients and its correlation with stress coping. Materials and Methods: An open-label trial was conducted with 20 refractory BPS/IC patients. Evaluations occurred at baseline and the 8th and 12th weeks. Primary endpoint was bladder pain evaluated by visual analogue scale (VAS). Secondary endpoints included daily frequency, nocturia and maximum voided volume obtained from a 3-day bladder diary, the O'Leary–Sant Symptom Score, and two questions accessing stress coping. Patients initiated daily doses of 8 mg silodosin, which could be titrated to 16 mg. Median values with percentiles 25 and 75 (25; 75) were used. Wilcoxon signed-rank test was used for comparisons. A minimally important difference of 3 points for pain was established to define clinically relevant improvement. Results: Median age was 56 years. Median pain score decreased from 8.00 (6.00; 8.00) at baseline to 4.00 (2.00; 5.50) (p < 0.001), meaning that the primary endpoint was reached. Total urinary frequency decreased from 14.00 (13.00; 21.00) to 9.00 (7.50; 11.00) (p < 0.05), and all the other secondary endpoints also showed a statistically significant improvement. Eleven patients improved by ≥3 pain points in VAS, meaning that 65% of patients that ended the study protocol achieved clinical significant improvement or, in the full analysis set, that 55% of the 20 initial patients improved significantly. Fourteen (82%) decreased by ≥2 micturitions/day. Overall, the cohort's stress coping was low. Conclusions: Silodosin can be an effective and well-tolerated treatment for refractory BPS/IC female patients. [ABSTRACT FROM AUTHOR]

Background: Men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), will have deterioration in the quality of life. Likewise, BPH can be complicated by damage to bladder function, bladder stones formation, hematuria, and impaired kidney function. The goal of treatment is to avoid all those effects caused by BPH. Objective: To evaluate the efficacy of tadalafil alone, silodosin alone, and the combination of both in the treatment of LUTS associated with BPH. Patients and methods: Patients in our department with BPH who had LUTS were assigned randomly to three groups: A (101 patients) received tadalafil, 5 mg; B (102 patients) received silodosin, 8 mg; and group C (105 patients) received the combination of tadalafil, 5 mg, and silodosin, 8 mg. For all participants, we asses changes in the maximum urinary flow rate (Qmax), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) score, Post-voiding urine (PVR) and all results were recorded and analyzed with the (SPSS) and Microsoft Excel 2010. Results: Qmax, IPSS, PVR and IIEF score improved significantly more with the combination of tadalafil and silodosin than with either drug alone (p < 0.001). Three months after treatment, the mean Qmax values were 14.4 ml/sec in group A, 15.2 ml/sec in group B, and 15.8 ml/sec in group C; and the mean IPSSs were 17.6 in group A, 16.7 in group B, and 15.6 in group C (p < 0.001). Conclusion: Tadalafil and silodosin are effective treatment options in men with BPH who have LUTS, but the combination of both is more effective and feasible in treating LUTS of BPH. [ABSTRACT FROM AUTHOR]

Background Ureteral stents represent a simple and effective method for renal and ureteric drainage and preservation of renal function owing to ureteric obstruction without external or visible devices. Objectives To evaluate the safety and efficacy of silodosin versus darifenacin and their combinations in reducing ureteral stent-related symptoms (SRS). Patients and methods A total of 178 patients who underwent ureteral stent stenting and developed SRS at first week were randomized into four groups (groups A–D) and assessed using a ureteral stent symptom questionnaire (USSQ) in each group. Group A used silodosin 8mg, group B used darifenacin 7.5mg, group C used both medications, and group D was the control group. All groups received the drugs for 14 days and then USSQ assessed in each group. Results USSQ score showed no statistically significant difference among the four groups after 1 week of ureteral stent application. At the end of the third week there was a significant decrease in USSQ score compared with group D. Comparing groups with each other showed that group C had the least USSQ score, indicating the best response. Conclusion The study showed significant improvement of ureteric SRSs in favor of combination of silodosin and darifenacin when compared with use only one of them. Both medications demonstrated a good safety and tolerability profile for medical improvement therapy in patients with ureteric stents. [ABSTRACT FROM AUTHOR]

Background: Precision medicine, which looks for high efficacy and low toxicity in therapies, has increased in popularity with omics technology. This work aims to discover novel and low-toxicity therapy options by examining the complex relationship between silodosin-induced side effects and the metabolomic profiles associated with its administration., Materials and Methods: The plasma samples of the control group and silodosin-treated rats were analyzed by LC-Q-TOF-MS/MS. Employing XCMS and MetaboAnalyst software, MS/MS data processed to detect compounds and investigate metabolic pathways. MATLAB 2019b was used for data categorization and multivariate analysis. A thorough comparison of METLIN and HMDB databases revealed 41m/z values with significant differences between the drug-treated and control groups (p <0.01 and fold analysis≥1.5)., Results: According to multivariate data analysis, 17-β-estradiol, taurocholic acid, L-kynurenine, N-formylkynurenine, D-glutamine, L-arginine, prostaglandin H2, prostaglandine G2, 15-keto-prostaglandin E2, calcidiol, thromboxane A2, 5'-methylthioadenosine, L-methionine and S-adenosylmethionine levels changed significantly compared to the control group. Differences in the metabolisms of glycerophospholipid, tyrosine, phenylalanine, arachidonic acid, cysteine and methionine, and biosynthesis of phenylalanine, tyrosine, and tryptophan, and aminoacyl-tRNA have been successfully demonstrated by metabolic pathway analysis. According to this study, vitamin D, D-glutamine, and L-arginine supplements can be recommended to prevent side effects such as fatigue, intraoperative floppy iris syndrome, blurred vision, and dizziness in the treatment of silodosin. Silodosin treatment negatively affected the immune system by affecting the kynurenine and tryptophan metabolism pathways., Conclusions: The study is a guide for silodosin treatments that offer low side effects and high therapeutic effect within the scope of precision medicine., (Copyright © 2024 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Objective: We aimed to investigate the efficacy of silodosin in patients with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) refractory to previous α-adrenergic receptor (AR) blocker therapy. Materials and Methods: Patients who did not benefit from alpha-blocker therapy but avoided surgical treatment constitute the population of our study. Seventy-five patients were studied in each group; Group 1 was given 8 mg of silodosin, while Group 2 continued the previous alpha-blocker treatment. Results: The initial mean international prostate symptom score (IPSS) was calculated as 20.81±0.97 in Group 1, in the third month there was a decrease of 17.12±1.25 (p

Background: Alpha-adrenoreceptor antagonists or alpha-blockers are used in the treatment of hypertension, in the therapy of benign prostatic hyperplasia and in medical expulsive treatment of ureteral stones. These agents may affect the sexual function, with differences between drugs within the same class, depending on their selectivity for receptor subtypes. The aim of this review was to analyze the effects of alpha-blockers on sexual function. Materials and methods: We conducted a systematic review and meta-analysis by searching PubMed, EMBASE and other databases for randomized controlled trials (RCTs) reporting sexual adverse effects in patients treated with alpha-blockers. Odds ratios for sexual dysfunction were calculated using random effects Mantel-Haenszel statistics. Results: Out of 608 records retrieved, 75 eligible RCTs were included in the meta-analysis. Compared with placebo, alphablockers were associated with increased odds of ejaculatory disorders both in patients with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH) (OR: 7.53, 95% CI: 3.77-15.02, Z = 5.73, p < 0.00001, I2 = 55%) and in patients with ureteral stones (OR: 2.88, 95% CI: 1.50-5.44, Z = 3.19, p < 0.001, I2 = 31%). Uroselective alpha-blockers showed higher odds of ejaculatory disorders. Conversely, nonselective alpha-blockers were not associated with higher odds of ejaculatory dysfunction. Silodosin was associated with increased odds of ejaculatory dysfunction compared with tamsulosin (OR: 3.52, 95% CI: 2.18-5.68, 15 series, 1512 participants, Z = 5.15, p < 0.00001, I2 = 0%). Naftopidil and alfuzosin showed lower odds of ejaculatory dysfunction compared to uroselective alpha-blockers. No statistically significant differences in the odds of erectile dysfunction were observed when alpha-blockers were compared to placebo. [ABSTRACT FROM AUTHOR]

Purpose The objective of this study was to investigate the change in near visual function after the administration of oral silodosin to patients with lower urinary tract symptoms (LUTS). Methods This prospective study included treatment-naive patients who were scheduled to start treatment with silodosin for LUTS. A comprehensive ophthalmological evaluation including the near vision and the automated pupillometry was performed at baseline and after 3 months of silodosin treatment. For subjective assessment of near visual ability and satisfaction, a Near Activity Visual Questionnaire-10 (NAVQ-10) was also used at the same time (higher scores indicating worse quality). Results Of 23 patients enrolled in this study, 15 continued with silodosin (8 mg once daily) treatment for 3 months and completed a follow-up evaluation. The mean age of participants was 60.4±8.4 years. Distant visual acuity and spherical error were unchanged after silodosin treatment. However, near vision acuity (logMAR) was improved after treatment (right, 0.47±0.36 vs. 0.38±0.39, P=0.018; left, 0.41±0.37 vs. 0.31±0.34, P=0.068; both, 0.27±0.26 vs. 0.21±0.27, P=0.043). Pupil size under room light decreased significantly in both eyes (right, 3.77±0.60 vs. 3.16±0.58, P=0.001; left, 3.72±0.80 vs. 3.21±0.75, P=0.002). The Rasch scale at NAVQ-10 improved from 54.7±9.9 to 48.5±11.2 (P=0.004). Conclusions This preliminary study demonstrated that highly selective alpha-1A adrenergic receptor antagonists such as silodosin improve near visual acuity and quality in patients with LUTS/benign prostatic hyperplasia. Decrease in pupil size caused by inhibition of adrenergic alpha 1 mediated contraction of iris dilator muscle is a possible mechanism underlying improved near vision.

Background: Alpha-adrenoreceptor antagonists or alpha-blockers are used in the treatment of hypertension, in the therapy of benign prostatic hyperplasia and in medical expulsive treatment of ureteral stones. These agents may affect the sexual function, with differences between drugs within the same class, depending on their selectivity for receptor subtypes. The aim of this review was to analyze the effects of alpha-blockers on sexual function. Materials and methods: We conducted a systematic review and meta-analysis by searching PubMed, EMBASE and other databases for randomized controlled trials (RCTs) reporting sexual adverse effects in patients treated with alpha-blockers. Odds ratios for sexual dysfunction were calculated using random effects Mantel-Haenszel statistics. Results: Out of 608 records retrieved, 75 eligible RCTs were included in the meta-analysis. Compared with placebo, alphablockers were associated with increased odds of ejaculatory disorders both in patients with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH) (OR: 7.53, 95% CI: 3.77-15.02, Z = 5.73, p < 0.00001, I2 = 55%) and in patients with ureteral stones (OR: 2.88, 95% CI: 1.50-5.44, Z = 3.19, p < 0.001, I2 = 31%). Uroselective alpha-blockers showed higher odds of ejaculatory disorders. Conversely, nonselective alpha-blockers were not associated with higher odds of ejaculatory dysfunction. Silodosin was associated with increased odds of ejaculatory dysfunction compared with tamsulosin (OR: 3.52, 95% CI: 2.18-5.68, 15 series, 1512 participants, Z = 5.15, p < 0.00001, I2 = 0%). Naftopidil and alfuzosin showed lower odds of ejaculatory dysfunction compared to uroselective alpha-blockers.No statistically significant differences in the odds of erectile dysfunction were observed when alpha-blockers were compared to placebo.

ObjectivePediatric urolithiasis is a common condition, and medical expulsive therapy has grown to be accepted by many parents. We carried out a meta-analysis to identify the efficacy and safety of α-adrenergic blockers for the treatment of pediatric urolithiasis.MethodsWe identified related articles from the PubMed, Embase, and Cochrane Library databases. All published randomized controlled trials (RCTs) describing the use of α-adrenergic blockers and placebo treatment for pediatric distal urolithiasis were involved. The outcomes included stone expulsion rate, stone expulsion time, pain episodes, need for analgesia, adverse events, and related subgroup analyses.ResultsA total of nine RCTs were involved in our study, including 586 patients. We found that α-adrenergic blockers could significantly increase the rate of stone expulsion [odds ratio (OR), 3.49; 95% confidence interval (CI), 2.38–5.12; p < 0.00001], reduce the stone expulsion time [mean difference (MD), −5.15; 95% CI, −8.51 to −1.80; p = 0.003], and decrease pain episodes (MD, −1.02; 95% CI, −1.33 to −0.72; p < 0.00001) and analgesia demand (MD, −0.92; 95% CI, −1.32 to −0.53; p < 0.00001) but had a higher incidence of side effects (MD, 2.83; 95% CI, 1.55 to 5.15; p = 0.0007). During subgroup analyses, different medications (tamsulosin, doxazosin, and silodosin) also exhibited better efficiencies than placebo, except for doxazosin, which showed no difference in expulsion time (MD, −1.23; 95% CI, −2.98 to 0.51; p = 0.17). The three kinds of α-adrenergic blockers also appeared to be better tolerated, except for tamsulosin with its greater number of adverse events (MD, 2.85; 95% CI, 1.34 to 6.03; p = 0.006). Silodosin led to a better expulsion rate than tamsulosin (OR, 0.42; 95% CI, 0.20 to 0.92; p = 0.03). In addition, α-adrenergic blockers increased the stone expulsion rate regardless of stone size and decreased the expulsion time of stones measuring 5 mm in expulsion time (MD, −3.61; 95% CI, −10.17 to 2.96; p = 0.28).ConclusionOur review suggests that α-adrenergic blockers are well-tolerated and efficient for treating pediatric distal urolithiasis. We also conclude that silodosin is the best choice of drug, offering a better expulsion rate, but it remains to be evaluated further by future studies.