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Background: Benign prostatic hyperplasia (BPH) is the most common cause for the lower urinary tract symptoms in men. The conservative management of BPH comprises of alpha blockers, especially selective alpha 1 adrenergic blockers for symptomatic relief. Aims and Objectives: We aimed to evaluate the efficacy and adverse effects of alpha blockers in managing BPH. Materials and Methods: After getting approval from the Institutional Human Ethics Committee and consent from subjects, this prospective, randomized, and controlled trial was conducted. In this study, patients under inclusion criteria were divided into two groups. Group I received silodosin 8 mg once daily for 8 weeks. Group II received tamsulosin 0.4 mg once daily for 8 weeks. Primary outcome measure was reduction in international prostate symptom score (IPSS). Adverse events during study period were recorded. Results: A total of 90 patients were enrolled in this study. Ten patients were excluded and remaining 80 patients were divided as 40 in Group I (Silodosin) and 40 in Group II (Tamsulosin), patients were followed up for 8 weeks. As primary outcome, the IPSS at 8th week was significantly <0 week, that is, baseline in both the groups. The comparison of IPSS within Group I and Group II at 0 week and 8th week was significant (P < 0.05). The quality of life comparison within Group I and Group II at 0 week and 8th week was significant (P < 0.05). Both the drugs were well tolerated. Retrograde ejaculation and diarrhea were noted with silodosin (Group I), dizziness and orthostatic hypotension were noted with Tamsulosin (Group II). Conclusion: The obtained results showed that both silodosin and tamsulosin produced significant improvement in IPSS and quality of Life in BPH patients. In silodosin group, retrograde ejaculation and diarrhea were notable adverse effects and in tamsulosin group, dizziness and orthostatic hypotension were noted.
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Background: Lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) is a common problem among aging men. Several classes of drugs are efficacious and safe, but the first-line treatment is with alpha-1 adrenergic blockers. They provide symptomatic relief and have to be taken for a longer duration to sustain the effect. The preferred alpha-blockers among the stockpile should be efficacious, tolerable, and also cost-effective. Aim and Objective: This study focuses to compare the cost-effectiveness of various alpha blockers prescribed in patients with LUTS-BPH. Materials and Methods: An observational study of 78 patients who were newly diagnosed with LUTS-BPH from April 2014 to May 2015 was conducted. Patients were followed up at 4 weeks and at 12 weeks after the drugs had been prescribed. Efficacy assessment was done on basis of change in International Prostate Symptom Score (IPSS) score over 12 weeks. Average cost-effectiveness ratio of different alpha-blockers prescribed was evaluated and compared with Mann-Whitney U test in order to find the most cost-effective alpha-blocker in the study. Results: All patients were prescribed alpha-blockers either alone or in combination with other drugs. Tamsulosin was prescribed to n = 46, Silodosin to n = 16 and Alfuzosin to n = 16. The efficacy in terms of Mean change in IPSS after 12 weeks of study was 11.34 ± 5.23 for Tamsulosin, 11.70 ± 5.9 for Silodosin and 10.87 ± 4.77 for Alfuzosin and average cost-effectiveness ratio was 108.74, 183.07 and 127.50 for Tamsulosin, Silodosin, and Alfuzosin, respectively. Conclusion: Tamsulosin was the most cost-effective drug among the prescribed alpha-blockers. Since all the prescribed alpha-blockers had comparable efficacy so we concluded that the most cost-effective drug should be preferred for long-duration treatment.
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@#Objective To observe the clinical effect of Mirabegron combined with Silodosin on detrusor hyperactivity with impaired contractile (DHIC).Methods From September, 2019 to December, 2021, 40 patients with DHIC in the Department of Urology of Beijing Bo'ai Hospital were selected and randomly divided into control group and experimental group, with 20 cases in each group. The control group took Silodosin only, and the experimental group took Mirabegron in addition, for four weeks. The urinary diary, residual urine volume, Overactive Bladder Symptom Score (OABSS) and quality of life (QOL) score were compared before and after treatment.Results A total of 18 patients in the control group and 19 in the experimental group finished the trial. After treatment, the number of night urination per day, the residual urine volume and QOL score improved in the control group (P<0.01); the number of urination per 24 hours, the number of night urination per day, the volume per urination, the residual urine volume, the daily urgency score, the OABSS score and QOL score improved in the experimental group (P<0.01). The number decrease of urination per 24 hours, the volume decrease of per urination, the daily urgency score decrease, the OABSS score decrease and QOL score decrease were more in the experimental group than in the control group (P<0.01). The adverse reactions included palpitations, increased heart rate, dyspareunia, increased blood pressure, gastric discomfort, postural hypotension, and retrograde ejaculation, and there was no significant difference between two groups (P > 0.05).Conclusion The efficacy of Mirabellone combined with Silodosin on DHIC is better than Silodosin only, and there was no significant increase in drug-related adverse effects.
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Background:To compare the treatment outcome of Silodosin alone and Silodosin with Tadalafil as a medical expulsive therapy (MET) of lower ureteric stone in western part of Rajasthan. Material And Methods:The study was conducted in a tertiary hospital of Dr. S.N. Medical College, Jodhpur over a period of 12 months (1st January, 2020 to 31st December, 2020). Out of 108 patients, 100 meet the inclusion criteria who were purposively assigned into 2 groups. 48 patients included in Silodosin alone group and 52 in Silodosin with Tadalafil group. Result:There was a significant higher stone expulsionrate in Silodosin with Tadalafil than Silodosin alone which was 88.46% vs75% respectively (P value 0.02). The mean stone expulsion time of Silodosin alone was14.33 (±3.1) days and Silodosin plus Tadalafil was 11.48(±2.3) days (P value 0.001). The episodes of pain in Silodosin alone were 0.7(±0.06) and 0.6(±0.2) in Silodosin with Tadalafil group that was statistically significant. Conclusion:The present study suggested that Silodosin with tadalafil combination therapy significantly increases ureteric stone expulsion rate and decreases the expulsion time and pain episodes than treatment with silodosin alone.
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Ureteric calculi are known to affect approximately 10 – 15% of the overall population. We wanted to determine as to whether silodosin can be used instead of DJ stenting in patients with uncomplicated ureteroscopic lithotripsy.METHODSWe selected 60 patients who underwent ureteroscopic lithotripsy (URSL) in the study group. They were divided into ‘stented group’ and ‘non-stented group on silodosin’. Patients with stone of 5 to 18 mm size with no intraoperative mucosal injury and no stricture were included in the study. All patients underwent surgery using an 8/9.8 Fr rigid ureteroscope, without ureteral dilation, with lithotripsy using an electro-hydraulic lithotripter, without extraction. A 4.5 Fr Double J stent was placed in the first group for three to four weeks. The patients underwent urine routine examination, plain x-ray KUB, and ultrasound abdomen before and after lithotripsy. Lower urinary tract symptoms and pain scores were recorded on 3, 7 and 15 days postoperatively. We compared mean operative time, emergency visits, rehospitalisation rates, and residual fragments between each group.RESULTSOut of 60 patients, 53.3% of patients had lower ureteric calculus, 30% had mid ureteric, and 16.7% had calculus at vesicoureteric junction. The mean calculus size on the left side was 10.23 mm, and on the right side was 10.33 mm. The mean intraoperative time was 33.23 minutes in stented and 29.9 minutes in the silodosin group (p< 0.003). Patients underwent assessment for flank pain, fever, and LUTS on postoperative days (POD) 3, 7 and 15. There was no statistically significant difference between the two groups though patients with DJ stent had more symptoms on inquiry. A total of 5 patients in the treatment groups were re-hospitalised, two patients (6.7%) in the stented group, and three patients (10%) in the silodosin group, out of which three patients (5%) required a secondary procedure which was not statistically significant. Three subjects treated with silodosin and 12 with the DJ stent in situ had residual fragments on POD 21 which was statistically significant (p 0.27).CONCLUSIONSPatients with uncomplicated URSL have similar recovery of renal function when treated with silodosin as compared to the placement of DJ stent. Treatment without stent with silodosin also has less irritative LUTS. We conclude that silodosin can be an alternative to DJ stent after uncomplicated ureteroscopic electrohydraulic lithotripsy, thereby reducing operative time and patient morbidity.
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Background: Post-operative urinary retention (POUR) is a common yet potentially serious morbidity with a reported incidence of 3 to 25%. This study aims to evaluate the effect of Silodosin, a super-selective alpha- 1a adrenergic blocking agent, as prophylaxis for post operative urinary retention in patients undergoing various surgical procedures.Methods: 100 patients were divided into two groups of 50 each. In group 1, patients were given prophylactic silodosin to evaluate its effect in post operative retention of urine and in group 2, patients were not given any medication.Results: In this study, POUR was diagnosed. POUR was higher in the older age group i.e. more in the age group of 41-60 yrs but in group 1, it was less as compared to group 2. POUR rate in general anaesthesia (GA) patients are less (11.1%) in group 1 as compared to (23.6%) in group 2. POUR rate in spinal anaesthesia (SA) patients are more (21.4%) in group 1 as compared (16.6%) in group 2. The total POUR rate in group 1 was lower (14%) as compared to (22%) in group 2.Conclusions: In our opinion patients operated under GA, irrespective of gender and type of surgery will benefit from prophylactic silodosin given in pre-operative period for the prevention of POUR and we highly recommend this. Patients who were operated under SA were not benefitted by giving prophylactic silodosin. Probably this is due to use of long acting spinal anesthetic agent in the form of bupivacaine in our patients.
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Background: Urinary calculus disease is one of the 3 most common urological diseases. It affects about 12% of the world population and has become a worldwide health problem. Of all the urinary tract stones 20% are ureteral stones, of which 70% are found in the distal ureter. The objective of the study is to study the effect of silodosin in the passage of calculi in the distal ureter compared to non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac sodium) and oral fluids.Methods: This study included a total of 90 patients between the study period from October 2016 to October 2018. 45 patients were chosen randomly and advised to take plenty of oral fluids and treated with NSAIDs and the other 45 patients were treated with silodosin 8 mg HS for one month along with oral fluids and NSAIDs. After 1 month if the stone was passed successfully, it was confirmed with ultrasonography, if failed, advised for surgery.Results: Majority of the patients were in the age group of 20-45 yrs. The mean size of the calculus was 5.60 cm on the right side and 5.71 cm on the left side. Out of the 45 patients who were on treatment with silodosin 35 patients had passed the calculi and 10 patients had no results with a success rate of 77.7%. In the 45 patients who were not on silodosin, 8 patients passed the calculi and 37 patients did not pass the calculi. 21 patients among the 45 underwent urethrorenoscopy.Conclusions: Silodosin is an effective and safe drug in the management of calculi in the distal ureter.
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Background: BPH is a major cause of bothersome lower urinary tract symptoms (LUTS) and affects quality of life (QoL) which deteriorates if not taken care with the passage of time. The aim and objective of the study was to compare the efficacy and safety of combination of silodosin and dutasteride with the combination of alfuzosin and dutasteride in patients of BPH.Methods: A randomized, open label, intention to treat study was carried out on newly diagnosed patients of BPH. Patients were randomly divided into two groups and followed up to 12 weeks. Group 1 of patients received a combination of silodosin 8 mg and dutasteride 0.5 mg (SD) (n=20) while the patients of group 2 received combination of alfuzosin 10 mg and dutasteride 0.5 mg (AD) (n=20). Primary endpoint was measured by changes in the mean baseline International prostate symptom score (I-PSS) and uroflowmetry and secondary outcome with changes observed on ultrasonography.Results: IPSS and IPSS-QOL significantly improved in both the treatment groups (p <0.001) along with mean maximum flow rate (Qmax) and mean average flow rate (Qavg). Prostate volume and residual urine volume showed a significant improvement in both the treatment groups at 12 weeks. However, the intergroup differences in IPSS, uroflowmetry and USG parameters were not significant. Both treatments were well tolerated.Conclusions: The current study established that both the drug combinations i.e. silodosin and dutasteride (SD) and alfuzosin and dutasteride (AD) largely have a comparable effect on both the dynamic and static components of BPH. Further, both drug combinations appear to have a comparable safety profile.
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PURPOSE: The urinary bladder (UB) is innervated by both sensory and autonomic nerves. Recent studies have shown that sensory neuropeptides induced contractions in the detrusor muscle. Therefore, in a mouse model, we investigated the presence of interactions between the submucosal sensory nerves and the autonomic nerves that regulate the motor function of the detrusor muscle. METHODS: UB samples from male C57BL/6 mice were isolated, cut into strips, and mounted in an organ bath. Dose-response curves to norepinephrine and phenylephrine were studied in UB strips with and without mucosa, and the effects of preincubation with a receptor antagonist and various drugs on relaxation were also studied using tissue bath myography. RESULTS: Phenylephrine-induced relaxation of the UB strips showed concentration-related effects. This relaxation appeared in both mucosa-intact and mucosa-denuded UB strips, and was significantly inhibited by lidocaine, silodosin, and guanethidine (an adrenergic neuronal blocker). Meanwhile, phenylephrine-induced relaxation was inhibited by pretreatment with propranolol and calcitonin gene-related peptide (CGRP)–depletory capsaicin in UB strips with and without mucosa. CONCLUSIONS: The present study suggests that phenylephrine activates the α-1A adrenergic receptor (AR) of the sensory nerve, and then activates capsaicin-sensitive sensory nerves to release an unknown substance that facilitates the release of norepinephrine from adrenergic nerves. Subsequently, norepinephrine stimulates β-ARs in the detrusor muscle in mice, leading to neurogenic relaxation of the UB. Further animal and human studies are required to prove this concept and to validate its clinical usefulness.
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Animales , Humanos , Masculino , Ratones , Neuronas Adrenérgicas , Vías Autónomas , Baños , Péptido Relacionado con Gen de Calcitonina , Capsaicina , Guanetidina , Lidocaína , Membrana Mucosa , Miografía , Neuropéptidos , Norepinefrina , Fenilefrina , Propranolol , Receptores Adrenérgicos , Receptores Adrenérgicos alfa 1 , Relajación , Vejiga UrinariaRESUMEN
PURPOSE: To evaluate the efficacy and safety of silodosin 8 mg once daily in a 12-week treatment of subjects with severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 100 subjects from 10 urology centers in Korea were included in this study. The inclusion criteria were as follows: age > or =50 years, International Prostate Symptom Score (IPSS) > or =20, quality of life (QoL) score > or =3, urine volume > or =120 mL and maximal urinary flow rate (Qmax) <15 mL/s, and postvoid residual volume (PVR) <100 mL. We assessed the improvement of LUTS with change in IPSS, QoL score, Qmax, PVR, and adverse events at baseline and 4 and 12 weeks after treatment with silodosin 8 mg once daily. RESULTS: The IPSS values were 23.27+/-3.34, 15.89+/-6.26, and 13.80+/-6.31 at baseline, 4, and 12 weeks, respectively, with significant improvements (p<0.0001, p=0.0214, respectively). QoL scores were 4.44+/-0.85, 3.38+/-1.20, and 3.04+/-1.20 at baseline, 4, and 12 weeks, respectively, and the differences were statistically significant (p<0.0001). There was a significant difference in Qmax between baseline and 12 weeks (p<0.0001) but not in PVR (p=0.9404) during the clinical trial. The most frequent adverse event in this study was ejaculation failure with 13 cases. However, no subject dropped out because of ejaculation failure, and in 12 of the 13 cases it was fully resolved without further treatment. CONCLUSIONS: Silodosin 8 mg once daily may be effective and safe in Korean patients with severe LUTS associated with BPH.
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Humanos , Masculino , Eyaculación , Corea (Geográfico) , Síntomas del Sistema Urinario Inferior , Estudios Prospectivos , Próstata , Hiperplasia Prostática , Calidad de Vida , Volumen Residual , UrologíaRESUMEN
Objective To evaluate the efficacy and safety of silodosin in the treatment of benign prostatic hyperplasia (BPH).Methods Randomized controlled trials (RCT) on the efficacy and safety of silodosin for the treatment of BPH were retrieved from Medline (1966-2012),Embase (1988-2012),Cochrane liberary,CMCC (1979-2012),CNK1 (1979-2012) and the quality of the included RCTs were evaluated using Cochrane systematic evaluation to analyze the data statistically using Rev Man 5.1.0 software.Results Six RCTs involving 2543 participants were included for the meta-analysis.Results of analysis showed that silodosin was effective in the treatment of BPH in term of total international prostate symptom score (IPSS) (standard mean difference (SMD) =2.92,95 ％ CI =2.19-3.65,P ＜ 0.05),voiding symptom score (SMD =1.92,95％ CI =1.44-2.39,P ＜0.05),storage symptom score (SMD =0.92,95％ CI=0.60-1.24,P ＜0.05),and maximum flow rate (Qmax) score (SMD =1.56,95％ CI=1.38-1.75,P ＜ 0.05),compared with the placebo.Silodosin 8 mg was more effective than tamsulosin 0.2 mg in term of IPSS-related parameters and Qmax (P ＜ 0.05).Silodosin 8mg and tamsulosin 0.4 mg were similarly effective in all the efficacy analyses.Abnormal ejaculation was less common with tamsulosin 0.2 mg and 0.4mg (P＜0.05); overall adverse events were similar with tamsulosin 0.2 and 0.4 mg (P ＜0.05).Conclusions Silodosin was significantly more effective than placebo and tamsulosin 0.2 mg in improving symptoms and as effective as tamsulosin 0.4 mg.For adverse events,abnormal ejaculation was more common with silodosin.
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Aim: To search for novel α_1-adrenoceptor(α_1-AR) antagonists. Methods: On the basis of hybridization principle with silodosin as the lead compound, twelve 5-[2-[4-[ ( substituted phenoxy) alkyl] piperazin-1-yl] propyl] indoline compounds were designed and synthesized by maintaining indoline while incorporating the 1-[(substituted phenoxy) alkyl] piperazine group. Results: The structures of synthesized target compounds were confirmed by the elemental analysis, IR, ESI-MS and ~1H NMR. Preliminary pharmacological test showed that pA_2 values of six target compounds were greater than 7. 50, which suggested that the compounds possessed considerable α_1-AR antagonic activity. Conclusion: 5-[2-[4-[ ( substituted phenoxy) alkyl] piperazin-1-yl] propyl] indoline compounds is potentially a new candidate for α_1-AR antagonist.