The effect of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder.

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.

Alpha-blockers: the magic pill for endourology-The great delusion.

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.

Understanding the side effects of chronic silodosin administration via untargeted metabolomics approach.

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-ß-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.

Development and validation of stability indicating RP-HPLC method for simultaneous estimation of silodosin and mirabegron in synthetic mixture.

The study focuses to validate and develop a precise, simple and accurate stability indicating RP-HPLC method for estimation simultaneously of and silodosin and mirabegron in synthetic mixture. The chromatographic separation was achieved by using Shimpack Solar C18 column (250×4.5mm, 5µm) with acetonitrile: 5mM ammonium acetate in ratio of 90:10% v/v as a mobile phase at a constant flow rate of about 1.2mL/min. The development and validation were carried out at detection wavelength of 229nm. We developed a robust RP-HPLC method, validated for linearity, precision, accuracy, specificity, and system suitability. The method demonstrated excellent linearity with correlation coefficient value r2 was nearly 0.998 with linearity range 8-18µg/mL for Silodosin and 24-54µg/mL for mirabegron. LOD and LOQ were found to be lower; hence, the method is sensitive. Percentage recovery was obtained 99.97% and 99.99% for silodosin and mirabegron, respectively. In case of precision, robustness and repeatability, RSD was found to be less than 2. The validated and developed RP-HPLC method offers an efficient and practical approach for the simultaneous quantification of silodosin and mirabegron in pharmaceutical formulations, making it a valuable tool for quality control and pharmaceutical research.

REVIEW OF ADVERSE DRUG REACTIONS OF MEDICINES USED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA REPORTED TO HALMED.

Benign prostatic hyperplasia is one of the most common diseases in men, with a prevalence rate of 50% in their 50s to 80% in their 80s, and is mostly treated with chronic drug therapy. The aim of this study was to analyze adverse drug reactions (ADR) to drugs used in benign prostate hyperplasia (BPH) treatment reported to HALMED from 2008 to 2021. Data on ADR reports in Croatia were obtained from the VigiFlow national database and on the use of drugs for BPH in Croatia from Drug Utilization Reports from HALMED. In the observed period, the number of reports on each BPH drug, total number of reports, seriousness of reported ADR, patient age and sex, type of reporter, and most reported ADRs were analyzed. Results showed that 438 ADR reports were received, of which 45.95% on tamsulosin as the most frequently used drug for BPH. Of all reports, 84% were non-serious, 96% were reported in men and 82% in patients older than 45 years. The most frequently reported ADRs were consistent with the known safety profile of BPH drugs. Pharmacists were the most common (47%) reporters of ADRs for BPH drugs, while 33% were reported by physicians. Analysis of the reported ADRs showed that most frequently reported ones were in line with the known safety profile of BPH drugs. However, given the prevalence of the disease and the extent of the use of BPH drugs, it could be argued that the number of reports could be higher (i.e., 34 reports/year). Reporting on ADRs is necessary to better understand the safety profile of drugs in the post-authorization period, and more information on the safe use of medicines could be collected by raising awareness of healthcare professionals.

Prospective comparison of tadalafil 5 mg alone, silodosin 8 mg alone, and the combination of both in treatment of lower urinary tract symptoms related to benign prostatic hyperplasia.

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.

Silodosin as a predisposing factor of intraoperative floppy iris syndrome (IFIS): an observational propensity score-matching cohort study.

PURPOSE: To evaluate the correlation between silodosin and intraoperative floppy iris syndrome (IFIS) and compare it with other a1-adrenergic receptor antagonists (a1-ARAs) and other factors predisposing to IFIS. METHODS: From the patients who underwent phacoemulsification between 2014 and 2020, we identified all patients who, during their preoperative assessment, reported an a1-ARAs intake (exposed group). These patients were matched utilizing a propensity score matching analysis with an otherwise homogenous group of patients (control group) based on demographics and systemic/ocular comorbidities. RESULTS: A total of 350 patients were included in each group. In the exposed group, 177 (50.6%) patients were exposed to tamsulosin, 105 (30%) to alfuzosin, 43 (12.2%) to silodosin. Regarding IFIS, it was observed in 21.5% of patients on tamsulosin (38/177), 11.4% on alfuzosin (12/105), 37.2% on silodosin (16/43), and 3.4% in the controlled group (12/350). In a multiple regression model analysis, the only two factors significantly associated with IFIS development were silodosin and tamsulosin yielding an adjusted odds ratio of 8.471 (95%CI 4.005-17.920) and 3.803 (95%CI 2.231-6.485), respectively. CONCLUSION: Silodosin has been demonstrated as a predisposing factor, strongly correlated with IFIS development. These results should increase cataract surgeons' awareness to assess their patients preoperatively for exposure to silodosin carefully and employ the appropriate prophylactic measures to ameliorate the impact of silodosin intake on the surgical outcome.

[Evaluation of the efficacy of silodosin 8 mg in comorbid patients with LUTS/BPH].

INTRODUCTION: According to domestic and foreign publications, benign prostatic hyperplasia (BPH) is one of the most common urological diseases among older men, which prevalence reaches 50% by the age of 60. AIM: To analyze the efficiency of the use of the alpha1-blocker silodosin at a dose of 8 mg a day in comorbid patients with lower urinary tract symptoms (LUTS), associated with BPH. MATERIALS AND METHODS: A total of 197 comorbid patients with LUTS/BPH were included in the study. All men underwent a standard examination. They were divided into 2 groups without differences in baseline parameters. In the main group (n=100) patients received silodosin at a dose of 8 mg, while in the control group 97 men did not receive any drug therapy for LUTS. DISCUSSION: There were significant differences between groups in the total IPSS score, postvoid residual (ml), maximum urine flow rate (ml/s), patient satisfaction with treatment efficacy based on the TS-VAS visual analogue scale (total score). However, we didnt find significant differences in rate of cardiovascular side effects between the groups. CONCLUSIONS: Treatment of comorbid patients with LUTS/BPH with silodosin at a dose of 8 mg results in significant improvement and is not associated with cardiovascular adverse events.

Evaluation of static and dynamic Pupillometry changes in men using Silodosin for benign prostatic hypertrophy.

BACKGROUND: Intraoperative floppy iris syndrome is a variant of the small pupil syndrome that has been observed during cataract surgery in some patients currently or previously treated with α1 adrenergic blockers. It is important for cataract surgeons to predict the probable complications preoperatively. Our study aims to evaluate the static and dynamic pupil characteristics of patients treated with silodosin-a selective α1 adrenergic blocker-for benign prostate hypertrophy (BPH) and to compare these values with healthy subjects using an automatic quantitative pupillometry system. METHODS: A total of 74 BPH patients treated with silodosin for six months (group 1) and 30 healthy subjects (group 2) were enrolled in this prospective multidisciplinary cross-sectional study. Static and dynamic pupillometric measurements were obtained under optimized conditions, and the results were compared between the two groups. RESULTS: Seventy-four male patients with a mean age of 63,35 ± 7,21 (46-77) years with BPH treated with silodosin and 30 normal male subjects with a mean age of 63,07 ± 4,73 (52-71) years were analyzed. There were statistically significant differences between the groups with regard to scotopic pupil diameter (PD), high photopic PD, and low photopic PD (p < 0.001, for each one). The patient group had statistically significant higher values of amplitude and velocity of pupil contraction and lower values of duration of pupil contraction and latency as well as duration and velocity of pupil dilation. CONCLUSION: The static and dynamic pupil characteristics of subjects treated with silodosin for BPH are different from those of healthy eyes. In addition, our results may have shed light on the risk for intraoperative floppy iris syndrome (IFIS) before cataract surgery; thus, surgeons can be alert and take precautions.

Comparison of the efficacy of silodosin and a terpene combination in the medical expulsive therapy of distal ureteral stones.

OBJECTIVE: We aimed to compare the efficacy of silodosin and a terpene combination in the treatment of distal ureteral stones. METHODOLOGY: The data of the patients admitted to the urology policlinic with renal colic, diagnosed with distal ureteral stones, and followed up with medical expulsive therapy between December 2017 and June 2018 were retrospectively reviewed. The patients were divided into two groups: Group 1 comprised 72 patients that received 8 mg/day silodosin and Group 2 consisted of 51 patients that were given three capsules of a terpene combination daily. The groups were compared in terms of the patients' demographic characteristics, medical history, localisation of the present stone, renal collecting system status, daily fluid intake, number of emergency service visits, number of additional analgesic applications needed, number of pain attacks, number of days off work, stone expulsion rate and time to stone expulsion. RESULTS: Of the total 123 patients, 98 (79.7%) were stone-free. The stone-free rate was 75.0% in Group 1 and 86.3% in Group 2, with no statistical difference between the two groups. However, the number of visits to the emergency service because of pain, number of additional analgesic applications required, number of days off work, and time to stone expulsion were statistically significantly lower in Group 2 than in Group 1. CONCLUSIONS: The treatment of distal ureteral stones with silodosin is as effective as the terpene combination. However, the terpene combination is more effective than silodosin in managing pain and accelerating stone expulsion.

Silodosin versus Tamsulosin as Medical Expulsive Therapy for Children with Lower-Third Ureteric Stones: Prospective Randomized Placebo-Controlled Study.

AIM: To compare the efficacy and safety of silodosin versus tamsulosin as medical expulsive therapy for stones of lower-third ureter in children. PATIENTS AND METHODS: This prospective single-blind placebo-controlled randomized study included 167 pediatric patients who presented with distal ureteric stone (DUS) less than 1 cm. Patients were randomized into 3 groups; group I received silodosin 4 mg once daily, and group II received tamsulosin 0.4 mg while those in group III had placebo. The side effects of the used drugs, both rate and time of stone expulsion, and number of pain episodes were compared among the study groups for a maximum of 4 weeks. RESULTS: Follow-up data of our patients after treatment revealed that the stone expulsion rate was significantly higher and the time to stone expulsion was significantly shorter in group I (89.3%, 12.4 ± 2.3 days) and group II (74.5%, 16.2 ± 4.2 days) compared to group III (51.8%, 21.2 ± 5.6). However, a statistically significant difference between silodosin and tamsulosin groups in favor of the former one was reported regarding the 2 studied items. Meanwhile, pain episodes requiring analgesia were statistically fewer in group I and II in contrast to placebo group. Adverse events were comparable among all groups. CONCLUSION: Silodosin provides significantly better stone expulsion rate and shorter expulsion time than tamsulosin for treatment of DUS. Both medications showed good safety profiles in children. However, further studies are required on a larger scale to confirm our results. Assessment of drug safety on younger age-group is still needed.

The clinical significance of abnormal ejaculation by silodosin. Is it important?

We aimed to evaluate the effect of the abnormal ejaculation (AEj) on patients using silodosin in terms of drug cessation. We also analysed the possible factors that may affect the decisions of patients with AEj to proceed or change their medication. The patients (n = 118) treated with silodosin 8 mg daily were prospectively analysed. In order to evaluate the erectile function, ejaculatory function, depression and sexual satisfaction; IIEF, MSHQ-EjD, Beck's depression and Golombok-Rust questionnaires were given to patients respectively. Patients were re-evaluated at the 3rd month of their treatment. The rate of AEj was 52.5%. Nearly 42% of the patients with AEj desired to stop their medication whereas it was 7.1% at patients without AEj (p < .001). The pre-treatment International Prostate Symptom Score (IPSS) and the decrease in IPSS score were significantly lower in patients who demand to stop their treatment (p < .05). AEj was significantly higher in patients who wanted to stop their medication (p < .001). Even if they had an AEj, patients who were happy with the clinical efficacy of silodosin did not want to change their drug. In addition to this, pre-treatment ejaculatory status was an important indicator for patients to decide drug cessation due to AEj side effect of silodosin.

Effects of tadalafil versus silodosin on voiding function in male patients with non-neurogenic detrusor underactivity: A comparative study using propensity score matching.

OBJECTIVES: To investigate and compare the effects of tadalafil and silodosin on lower urinary tract symptoms and voiding functions in men with non-neurogenic detrusor underactivity. METHODS: A total of 126 treatment-naive men with lower urinary tract symptoms diagnosed as non-neurogenic detrusor underactivity received tadalafil (5 mg/day) or silodosin (8 mg/day) for 12 months. After propensity score matching, parameter changes from before administration to 12 months since treatment initiation were assessed based on subjective symptoms and urodynamic findings, including bladder contractility index and maximum urinary flow rate, and were compared between the tadalafil treatment group and the silodosin group. Detrusor underactivity was defined as bladder contractility index <100 and bladder outlet obstruction index <40. RESULTS: After propensity score matching, the final analysis included 48 patients each in the tadalafil and silodosin groups. No significant differences in prostate volume, subjective symptoms or urodynamic parameters were detected between the groups at baseline. Compared with baseline, significant improvements in subjective symptoms and storage and voiding functions were observed at month 12 in both groups. Maximum urinary flow rate significantly improved by 1.7 mL/s in the silodosin group and by 3.0 mL/s in the tadalafil group. In addition, the mean bladder contractility index increased from 80.0 to 86.1 in the silodosin group and from 77.9 to 97.6 in the tadalafil group. Improvements in maximum urinary flow rate and bladder contractility index were significantly superior in the tadalafil group. CONCLUSIONS: Both tadalafil and silodosin significantly improve lower urinary tract symptoms and voiding function in patients with non-neurogenic detrusor underactivity. Furthermore, tadalafil is more effective than silodosin in improving bladder contractility index and maximum urinary flow rate.

Comparison of effects of tamsulosin and silodosin on subfoveal choroidal thickness and pupil size diameters in patients with prostatic hyperplasia.

PURPOSE: To compare the effects of selective α-1 adrenoceptor antagonists on subfoveal choroidal thickness (SFCT) and pupil diameter size (PDS). METHODS: This prospective study included 87 patients diagnosed with benign prostatic hyperplasia who were treated with tamsulosin hydrochloride (n = 41) or silodosin (n = 46). SFCT measurements were obtained using spectral domain optic coherence tomography (SD-OCT), and PDS measurements were obtained under mesopic, photopic and scotopic conditions using a photography-based topography system. SFCT and PDS were evaluated at baseline and 3-, 6- and 12-mo follow-ups. RESULTS: The initial mean SFCT was 270.53 ± 21.48 µm in tamsulosin group and 271.95 ± 24. 73 in silodosin group (P = 0.078). There was no statistically significant change in SFCT at the 3-mo visit. At the 6-mo follow-up, the mean SFCT was 281.34 ± 22.09 µm in tamsulosin group and 272.5 ± 22.4 µm in silodosin group. At the 12th month, the mean SFCT in tamsulosin group was 290.80 ± 17.27 µm, and it was 270.80 ± 13.14 µm in silodosin group. There was statistically significant difference in at 6th and 12-mo visits (P = 0.014 and P = 0.00). During the follow-up, both drugs induced a similar significant decrease in PDS under all conditions. CONCLUSIONS: Tamsulosin hydrochloride caused a significant increase in SFCT. In contrast, SFCT did not increase in silodosin group. The decreases in PDS achieved using both drugs were similar. This should be kept in mind when choroidal disease and its response to treatment are followed by CT imaging.

[A place of silodosin in the treatment of LUTS/BPH according to evidence-based medicine and real clinical practice].

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are common disorder in older men. The mainstay of conservative treatment for BPH is 1-adrenoblockers. A review of the literature on silodosin, a selective -adrenergic blocker, is discussed in the article. In clinical studies, there was a significant improvement in IPSS scores and maximum urinary flow rate in patients who received silodosin at a daily dose of 8 mg compared to those receiving placebo. It should be noted that silodosin has demonstrated long-term safety and early onset of efficacy. Compelling literature data to support the clinical benefit of silodosin for the treatment of LUTS associated with BPH is presented.

Changing Aspects of Male Sexual Functions Accompanying Treatment of Benign Prostatic Hyperplasia With Silodosin 8 mg Per Day.

BACKGROUND: Alpha-adrenergic antagonist treatment for benign prostatic hyperplasia (BPH) and drug-related sexual side effects are frequent in aging men. AIM: To investigate functional changes in erectile and ejaculatory aspects of male sexuality under Silodosin 8 mg per day treatment for BPH. METHODS: Sexually active patients diagnosed with BPH and who initiated Silodosin treatment were the subjects of the study. The International Prostate Symptom Score, premature ejaculation patient profile (PEP-male) questionnaire, Sexual Health Inventory for Men (SHIM) questionnaire, and estimated intravaginal ejaculation latency time (IELT) values of the participants were used to evaluate sexual functions. Data evaluation was performed in 8 urology clinics retrospectively. OUTCOMES: Participant ratings for SHIM, PEP, and estimated IELT were the primary outcome measures in the study. RESULTS: Among 187 recruited patients, data of 98 patients, who completed the trial period in the study, were eligible. The median age of the eligible participants who completed the trial period for 3 months was 59.5 years (range 45-82). 16 patients of 187 (8%) reported a desire for drug withdrawal for anejaculation during the recruitment period. 46 (46.9%) and 49 (50%) patients reported anejaculation in the first and third month of the treatment, respectively. De novo erectile dysfunction was noticed in 15 patients (15.3%). There was a significant increase in the estimated IELT of subjects in both the first (P = .01) and third (P = .002) month. SHIM-1 (P = .008), SHIM-total (P = .009), and PEP scores (P = .008) were also improved in the third month of the treatment. Neither baseline patient characteristics nor changes in the International Prostate Symptom Score after treatment predicted final outcomes with multivariable analysis. The subgroup analysis of participants who reported "anejaculation" also revealed better outcomes compared with participants ejaculating naturally in the third month as per SHIM ratings. CLINICAL IMPLICATIONS: Despite several male patients having dry orgasms due to Silodosin-induced anejaculation, the majority experienced improved erectile function. STRENGTHS & LIMITATIONS: The present study demonstrated pioneering results while investigating both erectile and ejaculatory dimensions of the male sexual function during Silodosin treatment for BPH. However, lack of partner evaluation, low follow-up rates, and lack of knowledge about reasons why subjects are lost to follow-up after drug initiation have limited our interpretation. CONCLUSION: Most patients using Silodosin 8 mg per day for BPH treatment experienced improvement in their erectile function, estimated IELT, and premature ejaculation profile in the third month of the treatment. Underlying mechanisms and reasons for individual differences necessitate further investigation. Cihan A, Kazaz IO, Yildirim Ö, et al. Changing Aspects of Male Sexual Functions Accompanying Treatment of Benign Prostatic Hyperplasia With Silodosin 8 mg Per Day. J Sex Med 2020;17:1094-1100.

A prospective double-blind, randomized, placebo-controlled study to evaluate the efficacy of silodosin 8 mg as an on-demand, reversible, nonhormonal oral contraceptive for males: a pilot study.

PURPOSE: As silodosin 8 mg, used for treating BPH, is known to cause absence of sperms in the ejaculate, its potential as an on-demand, reversible, nonhormonal oral contraceptive for males was assessed in this pilot study. METHODS: In this randomized, double-blind, placebo-controlled pilot study, healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited. Those using other contraceptive methods were excluded. During the first part of the study, silodosin 8 mg and placebo were crossed over among the randomly assigned two groups of participants and their post-masturbation semen and post-ejaculation urine were analyzed for spermatozoa. During the second part, both groups received silodosin 8 mg 3 h prior to heterosexual vaginal intercourse for 1 year. The primary outcome measure was the number of unintended pregnancies in their female partners. The secondary outcome measure was dropout rate due to adverse events. The clinical trial registry number was CTRI/2017/09/009872. RESULTS: The study period was January 2017 to December 2017 with sample size 63. Reversible azoospermia was noted following silodosin intake during the first part of the study. During the second part, no untended pregnancy was reported. None of the participants dropped out due to adverse events. Four patients were lost to follow-up. CONCLUSIONS: Silodosin 8 mg achieved total reversible azoospermia, hence prevented unintended pregnancies in the female partners of the males who used the drug as an on-demand oral contraceptive.

Silodosin improves functional consequences of lower urinary tract obstruction secondary to benign prostate hypertrophy, a proof of concept study in the spontaneously hypertensive rat supplemented with testosterone.

BACKGROUND: The main purpose of this study is to investigate the effect of silodosin on the urodynamic consequences in a previously established model of lower urinary tract symptoms associated with benign prostate hyperplasia, the spontaneously hypertensive rats (SHR) supplemented with testosterone. METHODS: Three groups of animals (8-week-old; n = 10/group) were considered: Wistar Kyoto (control) rats (WKY), SHR supplemented with testosterone at 3 mg/kg/day and treated with either vehicle (SHR-T, n = 10) or silodosin at 0.1 mg/kg/day (SHR-T + silodosin, n = 10) by oral gavage for 6 weeks. Cystometry experiments were performed. The bladder was harvested, weighed and paraffin-embedded for morphometric analysis. The prostate was also harvested and weighed. RESULTS: The number of animals included in the analysis were n = 10/10 for WKY and n = 7-8/10 for each SHR rats supplemented with testosterone group. SHR-T displayed a significant decrease in the intercontraction interval, infused volume and mean flow rate whereas the frequency of non-voiding contractions was increased. Silodosin improved the voiding behavior of SHR-T by significantly increasing the intercontraction interval, the infused volume and the mean flow rate and decreasing the number of non-voiding contractions. SHR-T displayed a significant increase in prostate and bladder weights and a 15% increase in the detrusor wall area compared to WKY. CONCLUSIONS: Chronic silodosin treatment relieved storage symptoms in SHR supplemented with testosterone and decreased the frequency of non-voiding detrusor contractions during the filling phase.

Effects of silodosin and tadalafil on bladder dysfunction in spontaneously hypertensive rats: Possible role of bladder blood flow.

OBJECTIVES: To investigate the effects of an alpha1-adrenoceptor antagonist, silodosin, or a phosphodiesterase type 5 inhibitor, tadalafil, on bladder overactivity in spontaneously hypertensive rats. METHODS: Twelve-week-old male spontaneously hypertensive rats were perorally administered silodosin (100 µg/kg), tadalafil (2 or 10 mg/kg) or vehicle once daily for 6 weeks. Wistar rats were used as normotensive controls and were treated with the vehicle. At 18-weeks-old, the effects of silodosin or tadalafil on blood pressure, bladder blood flow, urodynamic parameters (i.e. micturition frequency, urine output, inter-contraction interval, maximum voiding pressure, single voided volume and post-voiding residual urine volume), and bladder tissue levels of malondialdehyde, interleukin-6 and tumor necrosis factor-alpha were measured. RESULTS: A significant increase in blood pressure, micturition frequency and bladder tissue levels of malondialdehyde, interleukin-6 and tumor necrosis factor-alpha was noted in spontaneously hypertensive rats. The single voided volume, bladder capacity and bladder blood flow were significantly lower in the spontaneously hypertensive rats than in the Wistar rats. Treatment with silodosin and the higher dose of tadalafil improved the urodynamic parameters, bladder blood flow and bladder tissue levels of malondialdehyde in the spontaneously hypertensive rats without affecting the blood pressure and bladder tissue levels of interleukin-6 and tumor necrosis factor-alpha. CONCLUSIONS: Treatment with silodosin or tadalafil might improve hypertension-related bladder overactivity, as shown in spontaneously hypertensive rats through an improvement in the bladder blood flow and bladder tissue levels of oxidative stress.

[Efficiency and safety of silodosin for treatment of lower urinary tract symptoms, associated of benign prostatic hyperplasia].

Benign prostatic hyperplasia commonly is the most common cause of bladder outlet obstruction and can result in storage and micturition symptoms in men older than 40 years. Nowadays the 1-adrenoreceptor antagonists are the first-line drug for treatment of the lower urinary tract symptoms (LUTS). However, 1-adrenoreceptors are known to be present in other tissues and this fact could be a reason of potential risk of adverse events, associated with changes in peripheral vascular tone, such as orthostatic hypotension, syncopal states, dizziness, etc., especially in patients of advanced age, and those affected by cardiovascular diseases and taking essential drugs. A highly selective -adrenergic blocker silodosin is characterized by a lower rate of mentioned adverse events, comparable with placebo. Silodosin is also highly effective in treating of both types of LUTS in these patients, both as monotherapy and in combination with other drugs. A detailed analysis of clinical data confirming the high efficacy and safety of silodosin is presented in this review of the literature.